Citation
Correlation and Initiation of Nickel Sensitivity Due to Trauma during Orthodontic Treatment

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Title:
Correlation and Initiation of Nickel Sensitivity Due to Trauma during Orthodontic Treatment
Creator:
PARK, ERIC PATRICK ( Author, Primary )
Copyright Date:
2008

Subjects

Subjects / Keywords:
Allergies ( jstor )
Diaries ( jstor )
Household appliances ( jstor )
Lacerations ( jstor )
Nickel ( jstor )
Orthodontic appliances ( jstor )
Orthodontics ( jstor )
Patch tests ( jstor )
Sensitization ( jstor )
Stainless steels ( jstor )

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Source Institution:
University of Florida
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University of Florida
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Copyright Eric Patrick Park. Permission granted to University of Florida to digitize and display this item for non-profit research and educational purposes. Any reuse of this item in excess of fair use or other copyright exemptions requires permission of the copyright holder.
Embargo Date:
7/12/2007

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CORRELATION AND INITIATION OF NICKEL SENSITIVITY DUE TO TRAUMA
DURING ORTHODONTIC TREATMENT




















By

ERIC PATRICK PARK


A THESIS PRESENTED TO THE GRADUATE SCHOOL
OF THE UNIVERSITY OF FLORIDA IN PARTIAL FULFILLMENT
OF THE REQUIREMENTS FOR THE DEGREE OF
MASTER OF SCIENCE

UNIVERSITY OF FLORIDA

2007

































2007 Eric Patrick Park










ACKNOWLEDGMENTS

I would like to express my gratitude to my wife, Lorie, who has supported me in all my

endeavors. To my mother and father, I am grateful for the sacrifices they have made throughout

the years.











TABLE OF CONTENTS



A CK N O W LED G M EN T S ............ ................... .......................... ..... ........ 3

LIST O F TA B LE S........... .. .................... ................................. 5

LIST OF FIGUES ................... ......... ........... .......................... 6

ABSTRACT ........... ......... ............ ......... ........ ............

CHAPTER

1 INTRODUCTION................... ................... ................................. 9

2 MATERIAL AND METHODS..................................................... ........ 12

Experim ental D esign.............................................................. ...... 12
Statistical Analysis ............................................................... .... ..........14

3 RESULTS...................... .................... ......... 16

N ickel P atch T ests........... ..................................... ................. ......... .16
Previous Nickel Exposure from Piercings........................................ .............. 17
Traum a ............. ................... ........................................................... ... .....17
Orthodontic Appliances ................................ ... ..... ................... ...... .....18

4 DISCUSSION ................................... ........ ...................... ... ..... 22

5 C O N C L U SIO N S ................................................................26

APPENDIX

A Q U E S T IO N N A IR E ..................................................................................... .....................2 7

B ORTHODONTIC MAINTENANCE FORM......................................................................28

C MONTHLY PATIENT DIARY ............................................................ ............... 29



L IST O F R E F E R E N C E S .............................................................................. ...........................30

B IO G R A PH IC A L SK E T C H .............................................................................. .....................32






4









LIST OF TABLES

Table page

2-1 A ge ...................................... ............................... ........ .. 12

2-2 Band, bracket and wire nickel composition....................................................................15

3-1 Frequency of trauma.................................... .................... ... .......19

3-2 Wilcoxon signed rank test: Lacerations between appointments.......................................18

3-3 Wilcoxon signed rank test: Ulcerations between appointments.............. ...........18









LIST OF FIGURES


Figure p e

3-1 Nickel allergy patch results at baseline and six months into orthodontic treatment.........19

3-2 Sex differences for baseline nickel allergy patch results .................................. 16

3-3 Descriptive data on baseline piercings of individuals .......................................17

3-4 Average trauma experienced during the first four regularly scheduled appointments.......20

3-5 Change in archwire compositions with ongoing orthodontic treatment .....................20

3-6 Change in archwire dimensions with ongoing orthodontic treatment........................21











Abstract of Thesis Presented to the Graduate School
of the University of Florida in Partial Fulfillment of the
Requirements for the Degree of Master of Science

CORRELATION AND INITIATION OF NICKEL SENSITIVITY DUE TO TRAUMA
DURING ORTHODONTIC TREATMENT


By

Eric Patrick Park

May 2007

Chair: Calogero Dolce
Major: Dental Sciences

The purpose of this study was to determine the susceptibility of nickel sensitization caused

by nickel exposure via trauma from orthodontic appliances during orthodontic treatment. A

prospective, longitudinal study involving 30 orthodontic patients used nickel patch tests to test

for sensitivity and monthly diaries to record trauma. Subjects were recruited from the University

of Florida Graduate Orthodontic clinic. Eight patients failed to continue with the study, leaving

a sample of 22 individuals. Baseline nickel patch test were performed prior to and 6 months

after orthodontic treatment initiation. Trauma was recorded by each participant using a diary.

Appliances utilized were recorded at each regularly scheduled patient visit. Nickel patch results

and trauma were analyzed to see if a correlation existed.

The results showed that the sample undergoing six month patch testing was too small to

gain conclusive data on allergy incidence. Trauma, especially ulcerations, was seen to decrease

through the first three appointments, yet increased during the interval between the third and

fourth visit. Significance was seen for the decrease in ulcerations between visits 1 and 2

(P=0.02); lacerations showed a significant increase between visits 3 and 4 (P=0.03). No









conclusions were possible in correlating nickel sensitivity and orthodontic trauma due to a small

sample size. However, trauma is influenced by the stage of treatment due to the shape and

dimension of the archwires utilized for certain mechanics.











CHAPTER 1
INTRODUCTION

Nickel is second only to poison ivy/poison oak as the most common cause of allergic

contact dermatitis and ranked first in frequency of positive patch test reaction.' Oral

manifestations of nickel sensitivity include mucosal erythema with or without edema, contact

stomatitis, or lip swelling with a perioral rash.2 Eczematous dermatitis or hives/urticaria is

characteristic of the systemic signs for the allergic response.3

Estimated to be found in 14-20% of women and 2-4% of men within the United States,

nickel dermatitis is a cell-mediated, delayed, type IV hypersensitivity reaction that is a response

to the antigen nickel; it is a form of allergic contact dermatitis.4 Once thought of as an

"occupationally-required" allergy, nickel sensitivity has become a "consumer-related"

phenomenon correlating to rising contemporary trends and styles in piercings among both

females and males.

In regard to ear piercing and nickel sensitivity, studies have found a correlation between

the two factors. Dotterud and Falk5 found that 30.8% of Norwegian girls with their ears pierced

were nickel sensitive, compared to only 16.5 % of those without pierced ears. Similar results

were found by Larsson-Stymne and Widstrom;6 among girls with pierced ears, the frequency of

girls sensitive to nickel was found to be 13% and 1% in those without pierced ears. With

changing fashion trends, increasing numbers of males have begun to pierce their ears over the

years. In the study of Norwegian school children, Dotterud and Falk5 found that boys with

pierced ears had a higher rate of nickel sensitivity than boys without pierced ears.

Ear piercing and orthodontic treatment are similar in the fact that they both expose alloys

to a moist and corrosive environment, therefore, increasing the chance of nickel sensitization.









Prior to 1970, orthodontic therapy was conducted mainly with the metals gold and stainless steel.

Nickel-titanium (NiTi) was introduced to the field of orthodontics in 1971. NiTi alloys can

contain as much as 55 % nickel, compared to the 8% found in conventional stainless steel.7

Nickel titanium's properties of elasticity and shape memory make it an ideal alloy for

orthodontic tooth movement. It allows for a constant force to be applied over an extended period

of time.8 With improved technology, the field of orthodontics has been able to take advantage of

the different physical properties and phases martensitee and austenite) of copper Niti (CuNiti);

the wire has all the properties of nickel titanium, but with even more elasticity and less nickel

composition. CuNiti archwires can contain up to 50% nickel; the amount of nickel is less than

contemporary Niti wires, yet still significantly more than traditional stainless steel.

Corrosion of orthodontic alloys has raised concern due to the significance of metal ion

exposure. Fixed orthodontic appliances release a measurable amount of nickel when placed in

the oral cavity.9' 10 Agaoglu et al. 9 found that nickel saliva levels were the highest at the 1 month

treatment time in comparison with start of treatment, 1 week, 1 year, and 2 years into

orthodontics treatment with full appliances. The high nickel release in saliva at the 1 month

period may be due to usage of high nickel content archwires at the beginning of treatment to

level and align.

Previous studies have shown that an increased number of piercings or perforations

correlated to an increased frequency of sensitivity to nickel.5' 11 Ehrlich et al.11 concluded that

the number of body piercings has a positive bearing on the incidence of metal/nickel allergy in

men. Four percent of the unpierced sample was found to be metal sensitive compared to 11.1%

and 14.6% in the single and multiple pierced samples. With more piercings, the amount of

exposure to a moist and corrosive environment is increased. In relation to orthodontic treatment,









nickel appliances are always exposed to a moist and corrosive environment when in the oral

cavity.

Orthodontic treatment is a dynamic process that relies on the body's ability to adapt to

the appliances utilized. As orthodontic brackets and wires are introduced within the oral cavity,

mucosal irritation and lacerations may appear. When the patient's body reacts adversely to the

appliance compositions, a number of factors can be affected: treatment time and efficiency,

treatment satisfaction, general health and quality of life. Patients who seek orthodontic care

desire comfortable care, short treatment times, and esthetic results. Practitioners can provide

optimum treatment by utilizing the "state of the art" technologies available. The introduction of

NiTi has aided orthodontists in achieving patients' desired outcomes. Even so, with increased

exposure to vascular molecules and the immune system, trauma caused by nickel may trigger a

hypersensitivity response. In theory, with trauma or injury inflicted during orthodontic treatment

nickel sensitization may occur.

The objective of this study was to determine the susceptibility of nickel sensitization

caused by nickel exposure from orthodontic appliances during orthodontic treatment.









CHAPTER 2
MATERIALS AND METHODS

Experimental Design

A prospective, longitudinal study involving a desired recruitment goal of 100 patients

from the University of Florida Graduate orthodontic clinic was completed utilizing a daily diary

to record incidence of trauma during treatment with fixed appliances. Patients accepted into the

study were required to be at least 12 years of age, in good general health, have no previous

history of orthodontic treatment with fixed appliances, and treatment planned for orthodontic

treatment in at least one dental arch for a minimum period of 6 months with orthodontic arch

wires and brackets/bands. Participants received comprehensive orthodontic treatment based on

examination and need assessment from supervising clinical faculty. The study was approved by

the Institutional Review Board, and participants completed a written informed consent.

Of the 30 patients recruited, 22 patients continued to participate in the study; 8 patients

either declined orthodontic treatment or failed to partake in the evaluation for initial nickel

sensitivity prior to treatment. 59.1% (13) of the subjects were female; the male sample was

40.1% (9) of the total. Table 2-1 shows statistics of age.

Table 2-1. Age
Median Mean Minimum Maximum
15.8 18.8 11.9 64.1

Each patient was asked to complete a questionnaire to obtain demographic information

and assess general health (Appendix A). To account for previous systemic nickel exposure,

piercing and age at piercing were noted.

Nickel patch tests were administered to assess the initial nickel sensitivity level of each

subject prior to orthodontic treatment. Two 8mm Finn chambers on Scanpor, a hypoallergenic

surgical tape, were filled with either a 5% nickel sulfate suspension or a white petrolatum control









medium; each Finn chamber was filled slightly greater than 50%, according to manufacturer's

recommendations (approximately 4mm). The patches were placed on the patients' non-dominant

forearm for a period of 48 hours. Patients were instructed to avoid moisture around the patch site

and not to remove the patch unless a burning sensation was experienced or an extreme itching

sensation occurred. After 48 hours, the subjects returned to have an assessment of the patch site.

The allergen and control sites were examined by an orthodontic resident at the time of patient

presentation. Patch sites were photographed to be reexamined by a trained oral pathologist.

Scoring for the test sites were defined as follows:

1. (0) negative reaction
2. (1) weak nonvascularr) positive reaction: erythema, infiltration, possible papules
3. (2) strong (vascular) positive reaction: erythema, infiltration, papules, vesicles
4. (3) extreme positive reaction: bullous.

If a strong (2) or extreme (3) reaction was recorded, the patient was not allowed to continue with

the study; one subject did present with a strong positive reaction. After fixed appliance bonding,

patch tests were re-administered after the sixth regularly scheduled orthodontic appointment.

The fixed appliances utilized varied according to faculty preference and availability in

the graduate orthodontic clinic. Appliances and archwires were recorded for six regularly

scheduled orthodontic appointments on the orthodontic maintenance form (Appendix B). The

bands, brackets, archwires, and their compositions are listed in Table 2-2. The maintenance form

was completed by an orthodontic resident after each appointment; its components recorded four

areas: (1) nickel patch test results prior to treatment and after six appointments with fixed

appliances; (2) appliances worn; (3) emergency visits; and (4) iatrogenic trauma during appliance

placement. Emergency visits and the specific reason for the visit were recorded because of the

possible trauma associated with the event.









A daily diary form (Appendix C) was used to record intra-oral trauma experienced by the

patients. Trauma was explained to patients as an ulceration or laceration to the oral tissues. The

diary consisted of three sections: (1) new piercings and their locations during the observation

period; (2) utilization of wax to minimize discomfort experienced from lacerations or ulceration;

and (3) trauma experienced, along with time of experience in days. New piercings were

recorded to account for additional systemic nickel introduction. Upon orthodontic appointment,

the treating orthodontic resident noted any trauma that may not have been reported by the

patient. Diaries were initially given to the participants on the day of appliance bonding; patients

were instructed to return the completed diaries at subsequent appointments, at which point they

received a new form. Diaries were completed for six consecutive regular appointments.

Statistical Analysis

Descriptive data was determined for nickel allergy patch test results, trauma recorded by

diaries, and archwire changes. The study sample was analyzed by Wilcoxon signed rank tests to

assess significance of traumatic occurrences between treatment/appointment interval, at P <.05.










Table 2-2. Band, bracket and wire nickel composition
Appliance Manufacturer


Nickel Composition


Bands


1. American
2. GAC

3. 3M Unitek
Brackets
1. American
2. Damon
3. In-Ovation R
Sliding clip:
4. Mini-Ovation

5. SmartClip
6. Time 2

7. Victory
Wires
1. BioForce
2. Damon/Ormco CuNiTi

3. Nitinol Classic

4. Nitinol HA
5. Stainless steel
6. Nickel titanium
7. TMA


American Orthodontics
GAC
3M
Unitek

American Orthodontics
Ormco
GAC

GAC
3M
Unitek
American Orthodontics
3M
Unitek

GAC
Ormco
3M
Unitek
3M
Unitek
Ortho Technology
Ortho Technology
GAC/Ormco


3-15%
8-10%


10%


3-45%
3-5%
3-5%
10-20%
3-5%

10%
3-45%

9%


50.40%
49.10%

55%

55%
3.5-42.5%
55%
0%









CHAPTER 3
RESULTS

Nickel Patch Tests

Baseline patch tests were placed in order to determine the initial sensitivity of each

patient to nickel. Figure 3-1 illustrates the two positive findings; one was a weak reaction, while

the other was a strong positive reaction. The strong patch result excluded the patient from

continued participation within the study. Positive subjects consisted of one male and one female;

11.1% of males and 7.7% of females tested positively (Figure 3-2).


100%
90%
80%
70%
60%
60% ENegative
50% 00Positive
40%
30%
20%
10%
0% 11.1% 7.7%
0%
Male Female



Figure 3-2. Sex differences for baseline nickel allergy patch results.



Nickel patch tests were again administered after six months or six regularly scheduled

appointments with fixed orthodontic appliances. Only nine of the 22 initial patch subjects were

eligible for re-test at the chosen time of assessment. Figure 3-1 shows that all six individuals had

negative allergic responses.









Previous Nickel Exposure from Piercings

Pre-orthodontic, baseline, piercing data was recorded to take into consideration systemic

nickel exposure prior to fixed appliance therapy. The unpierced subjects consisted of males

only; 13 of the 16 pierced individuals were female. 100% of the females presented with

piercings (Figure 3-3).





100%
80% 18.7%

60% -

40% 81.3% U1000a Male
2 Female

0%
0%
Pierced Not Pierced


Figure 3-3. Descriptive data on baseline piercings of individuals.



Trauma

Patient diaries showed the number of lacerations and ulcerations experienced by patients

during each appointment interval. Figure 3-4 represents the average trend for each type of

trauma for the first four treatment intervals. Only the first four appointment periods were

utilized due to the small number of subjects/diaries available for the latter appointments. Both,

lacerations and ulcerations, tended to decrease with subsequent orthodontic treatment visits.

When compared to lacerations (1.1 to 0.9), ulcerations appeared to decrease a greater degree

from the first to the second appointment (2.5 to 0.8). Average trauma occurrences decreased at









the third visit, yet increased at the subsequent appointment. Total percentage of patients

experiencing trauma showed the same trend (Table 3-1).

Wilcoxon signed rank tests were performed to see if any significant differences existed

for traumatic occurrences between the appointment intervals (Tables 3-2 and 3-3). Subjects were

included only if diaries were available for the two visits within the appointment interval. Visits

after the fourth appointment were again not considered due to small sample size. Lacerations

showed a significance from visit 3 to visit 4 at P=0.03; more cuts were experienced from the

fourth visit than the third. The interval between visit 1 and visit 2 showed significance for

ulcerations experienced at P=0.02; as mentioned previously, average ulceration decreased

noticeably from the first to the second appointment.

Table 3-2. Wilcoxon signed rank test: lacerations between appointments
Appointment Interval Sample Mean Median SD Range P Value
Visit 1-2 13 0.15 0.00 1.68 7.00 0.63
Visit 2-3 11 0.91 0.00 1.64 6.00 0.13
Visit 3-4 10 -0.90 -1.00 0.88 2.00 0.03*
*Significance at P<0.05

Table 3-3. Wilcoxon signed rank rest: ulcerations between appointments
Appointment Interval Sample Mean Median SD Range P Value
Visit 1-2 13 1.46 1.00 1.94 7.00 0.02*
Visit 2-3 11 0.55 0.00 0.82 2.00 0.13
Visit 3-4 10 1.00 0.00 2.00 7.00 0.19
*Significance at P<0.05


Orthodontic Appliances

When observing types of archwires utilized in the subjects completing diaries, nickel

titanium and round wire showed an inverse correlation with stainless steel and rectangular wire

with subsequent visits. As treatment continued nickel titanium and round wire usage decreased

as stainless steel and rectangular wire usage showed an increase (Figures 3-5 and 3-6).











Table 3-1. Frequency of trauma
Visit Total Diaries Percent with Trauma
1 17 94.1
2 13 69.2
3 11 27.3
4 10 70.0
5 8 62.5
6 4 25.0


15

10


0 ---


1 1
0 0 0 0

1 2 3
Nickel Reaction

Baseline 6 Months/Appointment into treatment


Figure 3-1. Nickel allergy patch results at baseline and six months into orthodontic treatment.


















S-- Ulceration
1.5
E-I- Laceration
S1.1 1.2
I 0.9 1

0.5 0.8
r.2
0
1 2 3 4

Month/Visit


Figure 3-4. Average trauma experienced during the first four regularly scheduled appointments.


11





0 0


* Nickel Titanium (NiTi)
* Stainless Steel (SS)
0 NiTi/SS


Visits/Diaries


Figure 3-5. Change in archwire compositions with ongoing orthodontic treatment.










* Round
* Rectangular
o Round/
Rectangular


Visits/Diaries
Figure 3-6. Change in archwire dimensions with ongoing orthodontic treatment.


18
16
14
12
10
8
6
4
2
0


I


0 0


i 44 44
i4


L


vo









CHAPTER 4
DISCUSSION

Based on the limited sample of 22 subjects undergoing orthodontic therapy in fixed

appliances, this study analyzed the prevalence of nickel sensitivity, sensitivity incidence after 6

appointments/visits, and trauma experienced between treatment intervals. One of the main

factors contributing to a negative patient experience during orthodontic treatment is discomfort.

Discomfort may be caused from the annoyance and novelty of having appliances placed intra-

orally, pain from the alteration of the dental and periodontal apparatus, intra-oral trauma, and

many other contributory sources. Trauma, laceration and ulceration of the oral soft tissue, was

followed to see if it had an impact on nickel sensitivity.

Prevalence of nickel sensitivity among the 22 subjects was found to be 9.1%. When

values were examined between sexes, 7.7% of the females tested positive; this result was found

to be lower than the numbers found in other studies/sources.4'12 On the contrary, male

prevalence was at 11.1%, a higher than average finding.4 The explanation for these skewed

values is likely small sample size; of the 22 subjects tested, 9 were male and 13 female. Each

sex contained one positive subject. No control sites reacted positively.

Interestingly, both nickel positive participants presented with previous skin piercings for

jewelry. A study conducted on 520 men serving in the Swedish military found a significant

increase in the sensitivity of nickel; 7.9% tested positive among those men with their ears

pierced, while only 2.7% of those without pierced ears showed a positive result.13 Larsson-

Stymne and Widstrom6 found that among girls with pierced ears, the frequency of girls sensitive

to nickel was found to be 13%; only 1% prevalence was found in those without pierced ears.

For women, the primary means of sensitization is ear piercing with nickel-plated stud earrings;

accessories such as belt buckles, buttons, and other costume jewelry have been shown to cause









nickel reactions to a lesser degree in women.14,15,16,17,18 All of the female subjects in the present

study had piercings prior to orthodontic treatment. Our findings can not support or disprove the

data found in earlier studies without a larger sample size of both sexes.

Menne19 found it difficult to experimentally induce an allergic response to nickel;

repeated exposures to high nickel concentrations (10-15%) combined with irritants were needed

to produce a reaction. With increased exposure to vascular molecules and the immune system,

trauma caused by nickel may trigger a hypersensitivity response. In theory, with trauma or

injury inflicted during orthodontic treatment nickel sensitization may occur.

Trauma, in addition to new piercings during treatment, was recorded by patients utilizing

a take home diary. Of the 22 patients who underwent baseline patch testing, 17 continued to

participate by completing the monthly diaries given at each regularly scheduled appointment,

starting the day of appliance bonding. Studies have shown that compliance rates for diaries are

inconclusive at best.20 The biggest flaw with diaries is reliability of the patient to properly

document the ulcerations or lacerations experienced.

Reports of ulcerations and small wounds caused by fixed appliances have exceeded 75%

in previous studies.21'22 Findings from the current study showed up to 94.1% of subjects

experiencing trauma (Table 3-1). Trauma, particularly ulcerations, showed a decreasing trend

for the first three consecutive appointments. Ulcerations of the soft tissue usually occur with

orthodontic treatment as brackets and archwires are introduced as new sources of chronic

irritation. After initial archwire placement, alignment of the dentition occurs, coinciding with

movement of the brackets into new positions. The oral tissues adapt, since most of the

misalignment is corrected after the first appointment. Average ulcerative incidents decreased the

most between the first and second diary reports (Table 3-3).









Unexpectedly, trauma events increased between the third and fourth diary reports, with

significance seen in lacerations (Figure 3-4, Tables 3-1, 3-2, and 3-3). The archwires being

utilized during these appointments may provide an explanation for this occurrence. With good

alignment, archwire size must increase to provide the dimensions for torque and stiffness for

certain mechanics; archwire compositions also contribute to wire stiffness. As orthodontic

treatment proceeds, archwires usually move up from nickel titanium to stainless steel and from

round to rectangular. The stiffness of the wires may have led to more lacerations experienced by

the subjects. With self-ligating and low-friction brackets gaining popularity, more cuts to the

soft tissue can be a problem if the archwire is not secured properly by crimpable stop placement

and the archwire is allowed to move freely through the brackets.

Most nickel corrosion has been documented to occur early during orthodontic

treatment.9'10 As stated previously, much of the trauma experienced also occurs early in

orthodontic treatment. These findings would lead one to infer that more nickel is introduced

systemically early in treatment, allowing for increased chances of nickel sensitivity. Even so, of

the nine subjects patch tested after 6 months/visits of orthodontic treatment, no positive results

were produced. A larger sample is needed to provide more conclusive data.

There have been mixed results in regards to the idea that nickel containing dental

materials and products have the ability to elicit nickel sensitization or allergic reaction. Bass et

al.23 and Feasby et al.24 found correlations between nickel containing orthodontic appliances and

increase in sensitization to nickel. The study by Bass et al.23 resulted in 2 patients out of 29 with

an initial negative nickel patch test converting to a positive reaction after 4 months of

orthodontic treatment. Other studies have found contrasting results; Menezes et al.25 conducted a

study of 38 patients who received patch test for various substances before orthodontic treatment









and 2 months after the start of orthodontic appliances. There were no significant differences

between positive reactions for nickel sensitivity at the two patch test examinations. Janson et

al.26 studied the incidence of nickel sensitivity in 170 patients undergoing comprehensive

orthodontic treatment; they were divided into three categories: before, during, and after

treatment. No significant difference was determined between the groups, concluding that a

nickel reaction was not initiated by orthodontic treatment. The fact that 5 to 12 times the

concentration needed to elicit an extra-oral nickel reaction is required to cause sensitization

within the oral cavity supports the idea that orthodontic treatment may not induce an allergy.27

Huang et al.28 estimated nickel release for a full-mouth appliance to be 131 g in an environment

with a pH value of 2.5. This value is below the 600-2500kg needed to induce an allergy and

well under the daily dietary intake level of 300-500[g.29'24 Lack of oral mucosa reactivity to

nickel can be explained by a person's innate defenses. A salivary glycoprotein film can form to

create a barrier between the allergen presented and the oral mucosa; the richness of vasculature

and permeability of the oral mucosa can aid in the dispersion and absorption of allergens.2









CHAPTER 5
CONCLUSIONS

The results of this study showed no statistical differences in nickel patch testing results

prior to orthodontic treatment and six months after treatment initiation. The sample size did not

allow for proper statistical analysis of nickel incidence in a population undergoing orthodontic

therapy with regards to trauma.

Orthodontists inform their patients of the risks and benefits that may be experienced

during treatment with appliances. The American Association of Orthodontists' informed consent

form lists trauma as one of the possible risks. Ulceration or laceration of the oral soft tissue was

experienced by a large majority of the treatment population participating in this study. Trauma

reports showed significance with initial bracket and archwire placement and with placement of

more stiff archwires, composed of stainless steel and/or having a rectangular dimension. No

conclusive correlation was assessed with increased trauma and initiation of nickel sensitivity; the

literature has conflicting reports. It is assumed that the standard of care for orthodontic treatment

should result in minimal discomfort for the patient.

Due to inconclusive data on trauma experienced during orthodontic therapy and nickel

sensitivity, it would be in the best interest of the patient to increase patient satisfaction with

minimal injury caused by appliances, there by reducing increased systemic nickel exposure.

Practitioner awareness and patient education is vital to reduce the risk of creating sensitization or

exacerbating a preexisting condition. Standard of care can include cinching archwires, cutting

archwires to appropriate lengths, prophylactic placement of wax in areas more prone to

ulceration, and proper placement of archwire stops.









APPENDIX A
QUESTIONNAIRE


Name:
Address:


Phone:( ) -Gender: Male lI Female El
Date of Birth: / / Age:
Occupation:
If currently a student, what grade/year?
Have you had orthodontic treatment before? Yes E No 1
Do you currently have any piercings (ear, nose, tongue, etc.)? Yes E No E
If yes, check all that apply and date: EaiE / / Nose E / /
Tongue E / / Stomach / / Eye BrowE / /Genitals / /
Other:1 / / List where:


General Health: Do you have, or have you ever had the following:
Yes No Yes No
Heart problems L Hypertension E E
Asthma El E] Rheumatic Fever El OE
Blood disorders ] E Cancer ] E
Tuberculosis E] E Diabetes E] E
Emphysema E] El Seizures E] El
Thyroid Problems m] Arthritis ]
Seasonal Allergies EO O Allergic Reactions EO O
If you answered yes to any of the conditions stated above, please specify and give
details:


Are you currently taking any medications? Yes E No E
If yes, please list:









APPENDIX B
ORTHODONTIC MAINTENANCE

Patient:


Patch test Results: Initial
6 Months into treatment


Date of treatment start (Bond-up): / /
Bracket system:
Archwires(Brand/Type):
Date: _/_/Initial/First Month: Mx- Md-
Date: / / Second Month: Mx- Md-
Date: / / Third Month: Mx- Md-
Date: / / Fourth Month: Mx- Md-
Date: / / Fifth Month: Mx- Md-
Date: / / Sixth Month: Mx- Md-
Emergency Visits:
Date: / /
Reason for emergency:
If broken wire, what wire and how long has it been broken?


Date: / /
Reason for emergency:
If broken wire, what wire and how long has it been broken?


Date: / /
Reason for emergency:
If broken wire, what wire and how long has it been broken?









APPENDIX C
MONTHLY PATIENT DIARY




Patient :
Dates of Diary Period: / / / /
Have you had any new piercings during this period? Yes ] No ]
If yes, where on the body? Ear ] Nose] Tongue E Eye Brow[] Stomach E
Genitals-] Other List where:
Check one of the following boxes every time wax is used:
Date Cut Ulceration
_/ / O
/ / F O
/ / O

/ / O
/ / O
/ / O



Did you experience any trauma (Cuts/Ulcerations)?:
Date Cut Ulceration
/ / D ] How long did it last?
/ / D D How long did it last?
E/ / l How long did it last?

/ / How long did it last?
/ / O O How long did it last?
/ / How long did it last?
/ / O O How long did it last?
/ / O O How long did it last?









LIST OF REFERENCES


1. Garner LA. Contact dermatitis to metals. Dermatol Ther. 2004;17(4):321-7.

2. Spiechowicz E, Glantz PO, Axell T, Chmielewski W. Oral exposure to a nickel-
containing dental alloy of persons with hypersensitive skin reactions to nickel.
Contact Dermatitis. 1984 Apr; 10(4):206-11.

3. Allenby CF, Basketter DA. An arm immersion model of compromised skin (II). Influence
on minimal eliciting patch test concentrations of nickel. Contact Dermatitis. 1993
Mar;28(3):129-33.

4. Belsito DV. Allergic contact dermatitis. In: Freedberg IM, Eisen AZ, Wolff K.
Fitzpatrick's dermatology in general medicine. 5th ed. New York: McGraw-Hill,
1999:1447-61.

5. Dotterud LK, Falk ES. Metal allergy in north Norwegian schoolchildren and its
relationship with ear piercing and atopy. Contact Dermatitis. 1994 Nov;31(5):308-13.

6. Larsson-Stymne B, Widstrom L. Ear piercing: a cause of nickel allergy in schoolgirls?
Contact Dermatitis. 1985 Nov;13(5):289-93.

7. Andreasen GF, Morrow RE. Laboratory and clinical analyses of nitinol wire. Am J
Orthod. 1978 Feb;73(2):142-51.

8. Burstone CJ, Goldberg AJ. Beta titanium: a new orthodontic alloy.
Am J Orthod. 1980 Feb;77(2):121-32.

9. Agaoglu G, Arun T, Izgi B, Yarat A. Nickel and chromium levels in the saliva and serum
of patients with fixed orthodontic appliances. Angle Orthod. 2001 Oct;71(5):375-9.
Erratum in: Angle Orthod 2002 Aug;72(4):377.

10. Eliades T, Athanasiou AE. In vivo aging of orthodontic alloys: implications for corrosion
potential, nickel release, and biocompatibility. Angle Orthod. 2002 Jun;72(3):222-37.

11. Ehrlich A, Kucenic M, Belsito DV. Role of body piercing in the induction of metal
allergies. Am J Contact Dermat. 2001 Sep;12(3):151-5.

12. Josefson A, Farm G, Stymne B, Meding B. Nickel allergy and hand eczema: a 20-year
follow up. Contact Dermatitis. 2006 Nov;55(5):286--90.

13. Meijer C, Bredberg M, Fischer T, Widstrom L. Ear piercing, and nickel and cobalt
sensitization, in 520 young Swedish men doing compulsory military service. Contact
Dermatitis. 1995 Mar;32(3):147-9.

14. Fisher AA. The nickel controversy at home and abroad. Cutis 1993;52(3):134-46.









15. Shah M, Lewis FM, Gawkrodger DJ. Nickel as an occupational allergen: a survey of 368
nickel-sensitive subjects. Arch Dermatol 1998; 134(10):1231-6.

16. Gawkrodger DJ, Lewis FM, Shah M. Contact sensitivity to nickel and other metals in
jewelry reactors. J Am Acad Dermatol 2000;43(1 Pt 1):31-6.

17. Fisher AA. Nickel dermatitis in children. Cutis 1991;47(1):19-21.

18. Hurwitz S. Clinical pediatric dermatology: a textbook of skin disorders of childhood and
adolescence. 2nd ed. Philadelphia: WB Saunders, 1993:75-6.

19. Menne T. Prevention of nickel allergy by regulation of specific exposures.
Ann Clin Lab Sci. 1996 Mar--Apr;26(2):133-8.

20. Broderick JE, Stone AA. Paper and electronic diaries: Too early for conclusions on
compliance rates and their effects: comment on Green, Rafaeli, Bolger, Shrout, and Reis
(2006). Psychol Methods. 2006 Mar; 11(1): 106-11.

21. Kvam E, Gjerdet NR, Bondevik O. Traumatic ulcers and pain during orthodontic
treatment. Community Dent Oral Epidemiol. 1987 Apr;15(2):104-7.

22. Kvam E, Bondevik O, Gjerdet NR. Traumatic ulcers and pain in adults during
orthodontic treatment. Community Dent Oral Epidemiol. 1989 Jun; 17(3):154-7.

23. Bass JK, Fine H, Cisneros GJ. Nickel hypersensitivity in the orthodontic patient.
Am J Orthod Dentofacial Orthop. 1993 Mar;103(3):280-5.

24. Schroeder HA, Balassa JJ, Tipton IH. Abnormal trace metals in man: nickel. J Chronic
Dis. 1962 Jan;15:51-65.

25. Menezes LM, Campos LC, Quintao CC, Bolognese AM. Hypersensitivity to metals in
orthodontics. Am J Orthod Dentofacial Orthop. 2004 Jul;126(1):58-64.

26. Janson GR, Dainesi EA, Consolaro A, Woodside DG, de Freitas MR. Nickel
hypersensitivity reaction before, during, and after orthodontic therapy. Am J Orthod
Dentofacial Orthop. 1998 Jun;113(6):655--60.

27. Nielsen C, Klashcker F. Tesstudien an der Mundschleimhaut bei Ekzemallergikern. Dtsch
Jahn-Mund-Kieferheilkd. 1971; 57:201-18.

28. Huang HH, Chiu YH, Lee TH, Wu SC, Yang HW, Su KH, Hsu CC.Ion release from NiTi
orthodontic wires in artificial saliva with various acidities. Biomaterials. 2003
Sep;24(20):3585-92.

29. Kaaber K, Veien NK, Tjell JC. Low nickel diet in the treatment of patients with chronic
nickel dermatitis. Br J Dermatol. 1978 Feb;98(2):197-201.









BIOGRAPHICAL SKETCH

Eric Patrick Park was born in Birmingham, Alabama, and reared in Lithia Springs,

Georgia. He received his degree of Bachelor of Science in microbiology at the University of

Georgia in 2000. In 2004, he was awarded the degree of Doctor of Dental Medicine from the

University of Alabama School of Dentistry. Upon completion of his dental training, he

continued his education at the University of Florida College of Dentistry, receiving a certificate

in orthodontics and Master of Science in 2007.




Full Text

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CORRELATION AND INITIATION OF NICKEL SENSITIVITY DUE TO TRAUMA DURING ORTHODONTIC TREATMENT By ERIC PATRICK PARK A THESIS PRESENTED TO THE GRADUATE SCHOOL OF THE UNIVERSITY OF FLORIDA IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF MASTER OF SCIENCE UNIVERSITY OF FLORIDA 2007 1

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Eric Patrick Park 2

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ACKNOWLEDGMENTS I would like to express my gratitude to my wife, Lorie, who has supported me in all my endeavors. To my mother and father, I am grateful for the sacrifices they have made throughout the years. 3

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TABLE OF CONTENTS page ACKNOWLEDGMENTS.......3 LIST OF TABLES...................5 LIST OF FIGUES....6 ABSTRACT.....7 CHAPTER 1 INTRODUCTION....9 2 MATERIAL AND METHODS......12 Experimental Design..12 Statistical Analysis.14 3 RESULTS Nickel Patch Tests..16 Previous Nickel Exposure from Piercings..17 Trauma....17 Orthodontic Appliances...... 4 DISCUSSION.....22 5 CONCLUSIONS....................................................................................................................26 APPENDIX A QUESTIONNAIRE................................................................................................................27 B ORTHODONTIC MAINTENANCE FORM.........................................................................28 C MONTHLY PATIENT DIARY.............................................................................................29 LIST OF REFERENCES...............................................................................................................30 BIOGRAPHICAL SKETCH.........................................................................................................32 4 4

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LIST OF TABLES Table page 2-1 Age..12 2-2 Band, bracket and wire nickel composition.......................................................................15 3-1 Frequency of trauma... 3-2 Wilcoxon signed rank test: Lacerations between appointments.........................................18 3-3 Wilcoxon signed rank test: Ulcerations between appointments.18 5 5

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LIST OF FIGURES Figure page 3-1 Nickel allergy patch results at baseline and six months into orthodontic treatment......19 3-2 Sex differences for baseline nickel allergy patch results 3-3 Descriptive data on baseline piercings of individuals 3-4 Average trauma experienced during the first four regularly scheduled appointments.......20 3-5 Change in archwire compositions with ongoing orthodontic treatment ......20 3-6 Change in archwire dimensions with ongoing orthodontic treatment........ 6 6

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Abstract of Thesis Presented to the Graduate School of the University of Florida in Partial Fulfillment of the Requirements for the Degree of Master of Science CORRELATION AND INITIATION OF NICKEL SENSITIVITY DUE TO TRAUMA DURING ORTHODONTIC TREATMENT By Eric Patrick Park May 2007 Chair: Calogero Dolce Major: Dental Sciences The purpose of this study was to determine the susceptibility of nickel sensitization caused by nickel exposure via trauma from orthodontic appliances during orthodontic treatment. A prospective, longitudinal study involving 30 orthodontic patients used nickel patch tests to test for sensitivity and monthly diaries to record trauma. Subjects were recruited from the University of Florida Graduate Orthodontic clinic. Eight patients failed to continue with the study, leaving a sample of 22 individuals. Baseline nickel patch test were performed prior to and 6 months after orthodontic treatment initiation. Trauma was recorded by each participant using a diary. Appliances utilized were recorded at each regularly scheduled patient visit. Nickel patch results and trauma were analyzed to see if a correlation existed. The results showed that the sample undergoing six month patch testing was too small to gain conclusive data on allergy incidence. Trauma, especially ulcerations, was seen to decrease through the first three appointments, yet increased during the interval between the third and fourth visit. Significance was seen for the decrease in ulcerations between visits 1 and 2 (P=0.02); lacerations showed a significant increase between visits 3 and 4 (P=0.03). No 7

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conclusions were possible in correlating nickel sensitivity and orthodontic trauma due to a small sample size. However, trauma is influenced by the stage of treatment due to the shape and dimension of the archwires utilized for certain mechanics. 8

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CHAPTER 1 INTRODUCTION Nickel is second only to poison ivy/poison oak as the most common cause of allergic contact dermatitis and ranked first in frequency of positive patch test reaction. 1 Oral manifestations of nickel sensitivity include mucosal erythema with or without edema, contact stomatitis, or lip swelling with a perioral rash. 2 Eczematous dermatitis or hives/urticaria is characteristic of the systemic signs for the allergic response. 3 Estimated to be found in 14% of women and 2% of men within the United States, nickel dermatitis is a cell-mediated, delayed, type IV hypersensitivity reaction that is a response to the antigen nickel; it is a form of allergic contact dermatitis. 4 Once thought of as an occupationally-required allergy, nickel sensitivity has become a consumer-related phenomenon correlating to rising contemporary trends and styles in piercings among both females and males. In regard to ear piercing and nickel sensitivity, studies have found a correlation between the two factors. Dotterud and Falk 5 found that 30.8% of Norwegian girls with their ears pierced were nickel sensitive, compared to only 16.5 % of those without pierced ears. Similar results were found by Larsson-Stymne and Widstrom; 6 among girls with pierced ears, the frequency of girls sensitive to nickel was found to be 13% and 1% in those without pierced ears. With changing fashion trends, increasing numbers of males have begun to pierce their ears over the years. In the study of Norwegian school children, Dotterud and Falk 5 found that boys with pierced ears had a higher rate of nickel sensitivity than boys without pierced ears. Ear piercing and orthodontic treatment are similar in the fact that they both expose alloys to a moist and corrosive environment, therefore, increasing the chance of nickel sensitization. 9

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Prior to 1970, orthodontic therapy was conducted mainly with the metals gold and stainless steel. Nickel-titanium (NiTi) was introduced to the field of orthodontics in 1971. NiTi alloys can contain as much as 55 % nickel, compared to the 8% found in conventional stainless steel. 7 Nickel titaniums properties of elasticity and shape memory make it an ideal alloy for orthodontic tooth movement. It allows for a constant force to be applied over an extended period of time. 8 With improved technology, the field of orthodontics has been able to take advantage of the different physical properties and phases (martensite and austenite) of copper Niti (CuNiti); the wire has all the properties of nickel titanium, but with even more elasticity and less nickel composition. CuNiti archwires can contain up to 50% nickel; the amount of nickel is less than contemporary Niti wires, yet still significantly more than traditional stainless steel. Corrosion of orthodontic alloys has raised concern due to the significance of metal ion exposure. Fixed orthodontic appliances release a measurable amount of nickel when placed in the oral cavity. 9, 10 Agaoglu et al. 9 found that nickel saliva levels were the highest at the 1 month treatment time in comparison with start of treatment, 1 week, 1 year, and 2 years into orthodontics treatment with full appliances. The high nickel release in saliva at the 1 month period may be due to usage of high nickel content archwires at the beginning of treatment to level and align. Previous studies have shown that an increased number of piercings or perforations correlated to an increased frequency of sensitivity to nickel. 5, 11 Ehrlich et al. 11 concluded that the number of body piercings has a positive bearing on the incidence of metal/nickel allergy in men. Four percent of the unpierced sample was found to be metal sensitive compared to 11.1% and 14.6% in the single and multiple pierced samples. With more piercings, the amount of exposure to a moist and corrosive environment is increased. In relation to orthodontic treatment, 10

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nickel appliances are always exposed to a moist and corrosive environment when in the oral cavity. Orthodontic treatment is a dynamic process that relies on the bodys ability to adapt to the appliances utilized. As orthodontic brackets and wires are introduced within the oral cavity, mucosal irritation and lacerations may appear. When the patients body reacts adversely to the appliance compositions, a number of factors can be affected: treatment time and efficiency, treatment satisfaction, general health and quality of life. Patients who seek orthodontic care desire comfortable care, short treatment times, and esthetic results. Practitioners can provide optimum treatment by utilizing the state of the art technologies available. The introduction of NiTi has aided orthodontists in achieving patients desired outcomes. Even so, with increased exposure to vascular molecules and the immune system, trauma caused by nickel may trigger a hypersensitivity response. In theory, with trauma or injury inflicted during orthodontic treatment nickel sensitization may occur. The objective of this study was to determine the susceptibility of nickel sensitization caused by nickel exposure from orthodontic appliances during orthodontic treatment. 11

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CHAPTER 2 MATERIALS AND METHODS Experimental Design A prospective, longitudinal study involving a desired recruitment goal of 100 patients from the University of Florida Graduate orthodontic clinic was completed utilizing a daily diary to record incidence of trauma during treatment with fixed appliances. Patients accepted into the study were required to be at least 12 years of age, in good general health, have no previous history of orthodontic treatment with fixed appliances, and treatment planned for orthodontic treatment in at least one dental arch for a minimum period of 6 months with orthodontic arch wires and brackets/bands. Participants received comprehensive orthodontic treatment based on examination and need assessment from supervising clinical faculty. The study was approved by the Institutional Review Board, and participants completed a written informed consent. Of the 30 patients recruited, 22 patients continued to participate in the study; 8 patients either declined orthodontic treatment or failed to partake in the evaluation for initial nickel sensitivity prior to treatment. 59.1% (13) of the subjects were female; the male sample was 40.1% (9) of the total. Table 2-1 shows statistics of age. Table 2-1. Age Median Mean Minimum Maximum 15.8 18.8 11.9 64.1 Each patient was asked to complete a questionnaire to obtain demographic information and assess general health (Appendix A). To account for previous systemic nickel exposure, piercing and age at piercing were noted. Nickel patch tests were administered to assess the initial nickel sensitivity level of each subject prior to orthodontic treatment. Two 8mm Finn chambers on Scanpor, a hypoallergenic surgical tape, were filled with either a 5% nickel sulfate suspension or a white petrolatum control 12

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medium; each Finn chamber was filled slightly greater than 50%, according to manufacturers recommendations (approximately 4mm). The patches were placed on the patients non-dominant forearm for a period of 48 hours. Patients were instructed to avoid moisture around the patch site and not to remove the patch unless a burning sensation was experienced or an extreme itching sensation occurred. After 48 hours, the subjects returned to have an assessment of the patch site. The allergen and control sites were examined by an orthodontic resident at the time of patient presentation. Patch sites were photographed to be reexamined by a trained oral pathologist. Scoring for the test sites were defined as follows: 1. (0) negative reaction 2. (1) weak (nonvascular) positive reaction: erythema, infiltration, possible papules 3. (2) strong (vascular) positive reaction: erythema, infiltration, papules, vesicles 4. (3) extreme positive reaction: bullous. If a strong (2) or extreme (3) reaction was recorded, the patient was not allowed to continue with the study; one subject did present with a strong positive reaction. After fixed appliance bonding, patch tests were re-administered after the sixth regularly scheduled orthodontic appointment. The fixed appliances utilized varied according to faculty preference and availability in the graduate orthodontic clinic. Appliances and archwires were recorded for six regularly scheduled orthodontic appointments on the orthodontic maintenance form (Appendix B). The bands, brackets, archwires, and their compositions are listed in Table 2-2. The maintenance form was completed by an orthodontic resident after each appointment; its components recorded four areas: (1) nickel patch test results prior to treatment and after six appointments with fixed appliances; (2) appliances worn; (3) emergency visits; and (4) iatrogenic trauma during appliance placement. Emergency visits and the specific reason for the visit were recorded because of the possible trauma associated with the event. 13

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A daily diary form (Appendix C) was used to record intra-oral trauma experienced by the patients. Trauma was explained to patients as an ulceration or laceration to the oral tissues. The diary consisted of three sections: (1) new piercings and their locations during the observation period; (2) utilization of wax to minimize discomfort experienced from lacerations or ulceration; and (3) trauma experienced, along with time of experience in days. New piercings were recorded to account for additional systemic nickel introduction. Upon orthodontic appointment, the treating orthodontic resident noted any trauma that may not have been reported by the patient. Diaries were initially given to the participants on the day of appliance bonding; patients were instructed to return the completed diaries at subsequent appointments, at which point they received a new form. Diaries were completed for six consecutive regular appointments. Statistical Analysis Descriptive data was determined for nickel allergy patch test results, trauma recorded by diaries, and archwire changes. The study sample was analyzed by Wilcoxon signed rank tests to assess significance of traumatic occurrences between treatment/appointment interval, at P <.05. 14

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Table 2-2. Band, bracket and wire nickel composition Appliance Manufacturer Nickel Composition Bands 1. American American Orthodontics 3% 2. GAC GAC 8% 3. 3M Unitek 3M Unitek 10% Brackets 1. American American Orthodontics 3% 2. Damon Ormco 3% 3. In-Ovation R GAC 3% Sliding clip: 100% 4. Mini-Ovation GAC 3% 5. SmartClip 3M Unitek 10% 6. Time 2 American Orthodontics 3% 7. Victory 3M Unitek 9% Wires 1. BioForce GAC 50.40% 2. Damon/Ormco CuNiTi Ormco 49.10% 3. Nitinol Classic 3M Unitek 55% 4. Nitinol HA 3M Unitek 55% 5. Stainless steel Ortho Technology 3.5.5% 6. Nickel titanium Ortho Technology 55% 7. TMA GAC/Ormco 0% 15

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CHAPTER 3 RESULTS Nickel Patch Tests Baseline patch tests were placed in order to determine the initial sensitivity of each patient to nickel. Figure 3-1 illustrates the two positive findings; one was a weak reaction, while the other was a strong positive reaction. The strong patch result excluded the patient from continued participation within the study. Positive subjects consisted of one male and one female; 11.1% of males and 7.7% of females tested positively (Figure 3-2). Figure 3-2. Sex differences for baseline nickel allergy patch results. Nickel patch tests were again administered after six months or six regularly scheduled appointments with fixed orthodontic appliances. Only nine of the 22 initial patch subjects were eligible for re-test at the chosen time of assessment. Figure 3-1 shows that all six individuals had negative allergic responses. 1 1 8 12 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% N egative Positive 11.1% 7.7% Male Female 16

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Previous Nickel Exposure from Piercings Pre-orthodontic, baseline, piercing data was recorded to take into consideration systemic nickel exposure prior to fixed appliance therapy. The unpierced subjects consisted of males only; 13 of the 16 pierced individuals were female. 100% of the females presented with piercings (Figure 3-3). 100% 3 18.7% 80% 60% 6 81.3% 100% Male 13 40% Female 20% 0 0% Pierce d N ot Pierce d Figure 3-3. Descriptive data on baseline piercings of individuals. Trauma Patient diaries showed the number of lacerations and ulcerations experienced by patients during each appointment interval. Figure 3-4 represents the average trend for each type of trauma for the first four treatment intervals. Only the first four appointment periods were utilized due to the small number of subjects/diaries available for the latter appointments. Both, lacerations and ulcerations, tended to decrease with subsequent orthodontic treatment visits. When compared to lacerations (1.1 to 0.9), ulcerations appeared to decrease a greater degree from the first to the second appointment (2.5 to 0.8). Average trauma occurrences decreased at 17

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the third visit, yet increased at the subsequent appointment. Total percentage of patients experiencing trauma showed the same trend (Table 3-1). Wilcoxon signed rank tests were performed to see if any significant differences existed for traumatic occurrences between the appointment intervals (Tables 3-2 and 3-3). Subjects were included only if diaries were available for the two visits within the appointment interval. Visits after the fourth appointment were again not considered due to small sample size. Lacerations showed a significance from visit 3 to visit 4 at P=0.03; more cuts were experienced from the fourth visit than the third. The interval between visit 1 and visit 2 showed significance for ulcerations experienced at P=0.02; as mentioned previously, average ulceration decreased noticeably from the first to the second appointment. Table 3-2. Wilcoxon signed rank test: lacerations between appointments Appointment Interval Sample Mean Median SD Range P Value Visit 1-2 13 0.15 0.00 1.68 7.00 0.63 Visit 2-3 11 0.91 0.00 1.64 6.00 0.13 Visit 3-4 10 -0.90 -1.00 0.88 2.00 0.03* *Significance at P<0.05 Table 3-3. Wilcoxon signed rank rest: ulcerations between appointments Appointment Interval Sample Mean Median SD Range P Value Visit 1-2 13 1.46 1.00 1.94 7.00 0.02* Visit 2-3 11 0.55 0.00 0.82 2.00 0.13 Visit 3-4 10 1.00 0.00 2.00 7.00 0.19 *Significance at P<0.05 Orthodontic Appliances When observing types of archwires utilized in the subjects completing diaries, nickel titanium and round wire showed an inverse correlation with stainless steel and rectangular wire with subsequent visits. As treatment continued nickel titanium and round wire usage decreased as stainless steel and rectangular wire usage showed an increase (Figures 3-5 and 3-6). 18

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Table 3-1. Frequency of trauma Visit Total Diaries Percent with Trauma 1 17 94.1 2 13 69.2 3 11 27.3 4 10 70.0 5 8 62.5 6 4 25.0 25 20 20 Subject Numbe r 15 9 10 5 1 1 0 0 0 0 0 0 1 2 3 N ickel Reactio n 6 Months/Appointment into treatment Baseline Figure 3-1. Nickel allergy patch results at baseline and six months into orthodontic treatment. 19

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3 2.5 2.5 # Trauma Occurrences 2 Ulceration 1.5 Laceration 1.2 1.1 0.9 1 1 0.8 0.5 0.2 0 1 2 3 4 Month/Visi t Figure 3-4. Average trauma experienced during the first four regularly scheduled appointments. 17 Figure 3-5. Change in archwire compositions with ongoing orthodontic treatment. 11 8 6 0 1 1 2 0 1 2 2 0 2 4 6 8 10 12 14 16 18 Subjects N ickel Titanium (NiTi) Stainless Steel (SS) N iTi/SS 1 2 3 4 Visits/Diaries 20

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17 Figure 3-6. Change in archwire dimensions with ongoing orthodontic treatment. 9 4 2 0 2 4 4 0 2 3 4 0 2 4 6 8 10 12 14 16 18 Round Subjects Rectangular Round/ Rectangular 1 2 3 4 Visits/Diaries 21

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CHAPTER 4 DISCUSSION Based on the limited sample of 22 subjects undergoing orthodontic therapy in fixed appliances, this study analyzed the prevalence of nickel sensitivity, sensitivity incidence after 6 appointments/visits, and trauma experienced between treatment intervals. One of the main factors contributing to a negative patient experience during orthodontic treatment is discomfort. Discomfort may be caused from the annoyance and novelty of having appliances placed intra-orally, pain from the alteration of the dental and periodontal apparatus, intra-oral trauma, and many other contributory sources. Trauma, laceration and ulceration of the oral soft tissue, was followed to see if it had an impact on nickel sensitivity. Prevalence of nickel sensitivity among the 22 subjects was found to be 9.1%. When values were examined between sexes, 7.7% of the females tested positive; this result was found to be lower than the numbers found in other studies/sources. 4, 12 On the contrary, male prevalence was at 11.1%, a higher than average finding. 4 The explanation for these skewed values is likely small sample size; of the 22 subjects tested, 9 were male and 13 female. Each sex contained one positive subject. No control sites reacted positively. Interestingly, both nickel positive participants presented with previous skin piercings for jewelry. A study conducted on 520 men serving in the Swedish military found a significant increase in the sensitivity of nickel; 7.9% tested positive among those men with their ears pierced, while only 2.7% of those without pierced ears showed a positive result. 13 Larsson-Stymne and Widstrom 6 found that among girls with pierced ears, the frequency of girls sensitive to nickel was found to be 13%; only 1% prevalence was found in those without pierced ears. For women, the primary means of sensitization is ear piercing with nickel-plated stud earrings; accessories such as belt buckles, buttons, and other costume jewelry have been shown to cause 22

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nickel reactions to a lesser degree in women. 14,15,16,17,18 All of the female subjects in the present study had piercings prior to orthodontic treatment. Our findings can not support or disprove the data found in earlier studies without a larger sample size of both sexes. Menne 19 found it difficult to experimentally induce an allergic response to nickel; repeated exposures to high nickel concentrations (10%) combined with irritants were needed to produce a reaction. With increased exposure to vascular molecules and the immune system, trauma caused by nickel may trigger a hypersensitivity response. In theory, with trauma or injury inflicted during orthodontic treatment nickel sensitization may occur. Trauma, in addition to new piercings during treatment, was recorded by patients utilizing a take home diary. Of the 22 patients who underwent baseline patch testing, 17 continued to participate by completing the monthly diaries given at each regularly scheduled appointment, starting the day of appliance bonding. Studies have shown that compliance rates for diaries are inconclusive at best. 20 The biggest flaw with diaries is reliability of the patient to properly document the ulcerations or lacerations experienced. Reports of ulcerations and small wounds caused by fixed appliances have exceeded 75% in previous studies. 21,22 Findings from the current study showed up to 94.1% of subjects experiencing trauma (Table 3-1). Trauma, particularly ulcerations, showed a decreasing trend for the first three consecutive appointments. Ulcerations of the soft tissue usually occur with orthodontic treatment as brackets and archwires are introduced as new sources of chronic irritation. After initial archwire placement, alignment of the dentition occurs, coinciding with movement of the brackets into new positions. The oral tissues adapt, since most of the misalignment is corrected after the first appointment. Average ulcerative incidents decreased the most between the first and second diary reports (Table 3-3). 23

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Unexpectedly, trauma events increased between the third and fourth diary reports, with significance seen in lacerations (Figure 3-4, Tables 3-1, 3-2, and 3-3). The archwires being utilized during these appointments may provide an explanation for this occurrence. With good alignment, archwire size must increase to provide the dimensions for torque and stiffness for certain mechanics; archwire compositions also contribute to wire stiffness. As orthodontic treatment proceeds, archwires usually move up from nickel titanium to stainless steel and from round to rectangular. The stiffness of the wires may have led to more lacerations experienced by the subjects. With self-ligating and low-friction brackets gaining popularity, more cuts to the soft tissue can be a problem if the archwire is not secured properly by crimpable stop placement and the archwire is allowed to move freely through the brackets. Most nickel corrosion has been documented to occur early during orthodontic treatment. 9,10 As stated previously, much of the trauma experienced also occurs early in orthodontic treatment. These findings would lead one to infer that more nickel is introduced systemically early in treatment, allowing for increased chances of nickel sensitivity. Even so, of the nine subjects patch tested after 6 months/visits of orthodontic treatment, no positive results were produced. A larger sample is needed to provide more conclusive data. There have been mixed results in regards to the idea that nickel containing dental materials and products have the ability to elicit nickel sensitization or allergic reaction. Bass et al. 23 and Feasby et al. 24 found correlations between nickel containing orthodontic appliances and increase in sensitization to nickel. The study by Bass et al. 23 resulted in 2 patients out of 29 with an initial negative nickel patch test converting to a positive reaction after 4 months of orthodontic treatment. Other studies have found contrasting results; Menezes et al. 25 conducted a study of 38 patients who received patch test for various substances before orthodontic treatment 24

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and 2 months after the start of orthodontic appliances. There were no significant differences between positive reactions for nickel sensitivity at the two patch test examinations. Janson et al. 26 studied the incidence of nickel sensitivity in 170 patients undergoing comprehensive orthodontic treatment; they were divided into three categories: before, during, and after treatment. No significant difference was determined between the groups, concluding that a nickel reaction was not initiated by orthodontic treatment. The fact that 5 to 12 times the concentration needed to elicit an extra-oral nickel reaction is required to cause sensitization within the oral cavity supports the idea that orthodontic treatment may not induce an allergy. 27 Huang et al. 28 estimated nickel release for a full-mouth appliance to be 131g in an environment with a pH value of 2.5. This value is below the 600-2500g needed to induce an allergy and well under the daily dietary intake level of 300-500g. 29,24 Lack of oral mucosa reactivity to nickel can be explained by a persons innate defenses. A salivary glycoprotein film can form to create a barrier between the allergen presented and the oral mucosa; the richness of vasculature and permeability of the oral mucosa can aid in the dispersion and absorption of allergens. 2 25

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CHAPTER 5 CONCLUSIONS The results of this study showed no statistical differences in nickel patch testing results prior to orthodontic treatment and six months after treatment initiation. The sample size did not allow for proper statistical analysis of nickel incidence in a population undergoing orthodontic therapy with regards to trauma. Orthodontists inform their patients of the risks and benefits that may be experienced during treatment with appliances. The American Association of Orthodontists informed consent form lists trauma as one of the possible risks. Ulceration or laceration of the oral soft tissue was experienced by a large majority of the treatment population participating in this study. Trauma reports showed significance with initial bracket and archwire placement and with placement of more stiff archwires, composed of stainless steel and/or having a rectangular dimension. No conclusive correlation was assessed with increased trauma and initiation of nickel sensitivity; the literature has conflicting reports. It is assumed that the standard of care for orthodontic treatment should result in minimal discomfort for the patient. Due to inconclusive data on trauma experienced during orthodontic therapy and nickel sensitivity, it would be in the best interest of the patient to increase patient satisfaction with minimal injury caused by appliances, there by reducing increased systemic nickel exposure. Practitioner awareness and patient education is vital to reduce the risk of creating sensitization or exacerbating a preexisting condition. Standard of care can include cinching archwires, cutting archwires to appropriate lengths, prophylactic placement of wax in areas more prone to ulceration, and proper placement of archwire stops. 26

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APPENDIX A QUESTIONNAIRE Name:______________________________________________ Address:____________________________________________ ____________________________________________ Phone:(____)______-__________ Gender: Male Female Date of Birth:____/____/____ Age:______ Occupation:__________________________________________ If currently a student, what grade/year?__________________ Have you had orthodontic treatment before? Yes No Do you currently have any piercings (ear, nose, tongue, etc.)? Yes No If yes, check all that apply and date: Ear __/__/__ Nose __/__/__ Tongue __/__/__ Stomach __/__/__ Eye Brow __/__/__Genitals __/__/__ Other:____/__/__ List where:______________________________________ _____________________________________________________________________ General Health: Do you have, or have you ever had the following: Yes No Yes No Heart problems Hypertension Asthma Rheumatic Fever Blood disorders Cancer Tuberculosis Diabetes Emphysema Seizures Thyroid Problems Arthritis Seasonal Allergies Allergic Reactions If you answered yes to any of the conditions stated above, please specify and give details:__________________________________________________________________________________________________________________________________ Are you currently taking any medications? Yes No If yes, please list:______________________________________________________ 27

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APPENDIX B ORTHODONTIC MAINTENANCE Patient: ___________________________________________________ Patch test Results: Initial____________________ 6 Months into treatment____________________ Date of treatment start (Bond-up):____/____/____ Bracket system: _____________________________ Archwires(Brand/Type): Date:__/__/__Initial/First Month: Mx-____________Md-_____________ Date:__/__/__ Second Month: Mx-____________Md-_____________ Date:__/__/__ Third Month: Mx-____________Md-_____________ Date:__/__/__ Fourth Month: Mx-____________Md-_____________ Date:__/__/__ Fifth Month: Mx-____________Md-_____________ Date:__/__/__ Sixth Month: Mx-____________Md-_____________ Emergency Visits: Date: ____/____/_____ Reason for emergency: ________________________________________ If broken wire, what wire and how long has it been broken? _________ ____________________________________________________________ Date: ____/____/_____ Reason for emergency: ________________________________________ If broken wire, what wire and how long has it been broken? _________ ____________________________________________________________ Date: ____/____/_____ Reason for emergency: ________________________________________ If broken wire, what wire and how long has it been broken? _________ 28

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APPENDIX C MONTHLY PATIENT DIARY Patient : ___________________________________________________ Dates of Diary Period: ____/____/____ ____/____/____ Have you had any new piercings during this period? Yes No If yes, where on the body? Ear Nose Tongue Eye Brow Stomach Genitals Other List where:__________________________________ Check one of the following boxes every time wax is used: Date Cut Ulceration ____/____/____ ____/____/____ ____/____/____ ____/____/____ ____/____/____ ____/____/____ ____/____/____ Did you experience any trauma (Cuts/Ulcerations)?: Date Cut Ulceration ____/____/____ How long did it last?________________ ____/____/____ How long did it last?________________ ____/____/____ How long did it last?________________ ____/____/____ How long did it last?________________ ____/____/____ How long did it last?________________ ____/____/____ How long did it last?________________ ____/____/____ How long did it last?________________ ____/____/____ How long did it last?________________ 29

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LIST OF REFERENCES 1. Garner LA. Contact dermatitis to metals. Dermatol Ther. 2004;17(4):321. 2. Spiechowicz E, Glantz PO, Axell T, Chmielewski W. Oral exposure to a nickel-containing dental alloy of persons with hypersensitive skin reactions to nickel. Contact Dermatitis. 1984 Apr;10(4):206. 3. Allenby CF, Basketter DA. An arm immersion model of compromised skin (II). Influence on minimal eliciting patch test concentrations of nickel. Contact Dermatitis. 1993 Mar;28(3):129. 4. Belsito DV. Allergic contact dermatitis. In: Freedberg IM, Eisen AZ, Wolff K. Fitzpatrick's dermatology in general medicine. 5th ed. New York: McGraw-Hill, 1999:1447. 5. Dotterud LK, Falk ES. Metal allergy in north Norwegian schoolchildren and its relationship with ear piercing and atopy. Contact Dermatitis. 1994 Nov;31(5):308. 6. Larsson-Stymne B, Widstrm L. Ear piercing: a cause of nickel allergy in schoolgirls? Contact Dermatitis. 1985 Nov;13(5):289. 7. Andreasen GF, Morrow RE. Laboratory and clinical analyses of nitinol wire. Am J Orthod. 1978 Feb;73(2):142. 8. Burstone CJ, Goldberg AJ. Beta titanium: a new orthodontic alloy. Am J Orthod. 1980 Feb;77(2):121. 9. Agaoglu G, Arun T, Izgi B, Yarat A. Nickel and chromium levels in the saliva and serum of patients with fixed orthodontic appliances. Angle Orthod. 2001 Oct;71(5):375. Erratum in: Angle Orthod 2002 Aug;72(4):377. 10. Eliades T, Athanasiou AE. In vivo aging of orthodontic alloys: implications for corrosion potential, nickel release, and biocompatibility. Angle Orthod. 2002 Jun;72(3):222. 11. Ehrlich A Kucenic M Belsito DV Role of body piercing in the induction of metal allergies. Am J Contact Dermat. 2001 Sep;12(3):151 5. 12. Josefson A, Farm G, Stymne B, Meding B. Nickel allergy and hand eczema: a 20-year follow up. Contact Dermatitis. 2006 Nov;55(5):286-90. 13. Meijer C, Bredberg M, Fischer T, Widstrom L. Ear piercing, and nickel and cobalt sensitization, in 520 young Swedish men doing compulsory military service. Contact Dermatitis. 1995 Mar;32(3):147. 14. Fisher AA. The nickel controversy at home and abroad. Cutis 1993;52(3):134. 30

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15. Shah M, Lewis FM, Gawkrodger DJ. Nickel as an occupational allergen: a survey of 368 nickel-sensitive subjects. Arch Dermatol 1998;134(10):1231. 16. Gawkrodger DJ, Lewis FM, Shah M. Contact sensitivity to nickel and other metals in jewelry reactors. J Am Acad Dermatol 2000;43(1 Pt 1):31. 17. Fisher AA. Nickel dermatitis in children. Cutis 1991;47(1):19. 18. Hurwitz S. Clinical pediatric dermatology: a textbook of skin disorders of childhood and adolescence. 2nd ed. Philadelphia: WB Saunders, 1993:75. 19. Menne T. Prevention of nickel allergy by regulation of specific exposures. Ann Clin Lab Sci. 1996 Mar-Apr;26(2):133. 20. Broderick JE, Stone AA. Paper and electronic diaries: Too early for conclusions on compliance rates and their effects: comment on Green, Rafaeli, Bolger, Shrout, and Reis (2006). Psychol Methods. 2006 Mar;11(1):106. 21. Kvam E, Gjerdet NR, Bondevik O. Traumatic ulcers and pain during orthodontic treatment. Community Dent Oral Epidemiol. 1987 Apr;15(2):104. 22. Kvam E, Bondevik O, Gjerdet NR. Traumatic ulcers and pain in adults during orthodontic treatment. Community Dent Oral Epidemiol. 1989 Jun;17(3):154. 23. Bass JK, Fine H, Cisneros GJ. Nickel hypersensitivity in the orthodontic patient. Am J Orthod Dentofacial Orthop. 1993 Mar;103(3):280. 24. Schroeder HA, Balassa JJ, Tipton IH. Abnormal trace metals in man: nickel. J Chronic Dis. 1962 Jan;15:51. 25. Menezes LM, Campos LC, Quintao CC, Bolognese AM. Hypersensitivity to metals in orthodontics. Am J Orthod Dentofacial Orthop. 2004 Jul;126(1):58. 26. Janson GR, Dainesi EA, Consolaro A, Woodside DG, de Freitas MR. Nickel hypersensitivity reaction before, during, and after orthodontic therapy. Am J Orthod Dentofacial Orthop. 1998 Jun;113(6):655-60. 27. Nielsen C, Klashcker F. Tesstudien an der Mundschleimhaut bei Ekzemallergikern. Dtsch Jahn-Mund-Kieferheilkd. 1971; 57:201. 28. Huang HH, Chiu YH, Lee TH, Wu SC, Yang HW, Su KH, Hsu CC.Ion release from NiTi orthodontic wires in artificial saliva with various acidities. Biomaterials. 2003 Sep;24(20):3585. 29. Kaaber K, Veien NK, Tjell JC. Low nickel diet in the treatment of patients with chronic nickel dermatitis. Br J Dermatol. 1978 Feb;98(2):197. 31

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BIOGRAPHICAL SKETCH Eric Patrick Park was born in Birmingham, Alabama, and reared in Lithia Springs, Georgia. He received his degree of Bachelor of Science in microbiology at the University of Georgia in 2000. In 2004, he was awarded the degree of Doctor of Dental Medicine from the University of Alabama School of Dentistry. Upon completion of his dental training, he continued his education at the University of Florida College of Dentistry, receiving a certificate in orthodontics and Master of Science in 2007. 32