A PROSPECTIVE, LONGITUDINAL, STUDY OF INITIAL DISCOMFORT

ASSOCIATED WITH FIXED AND INVISALIGN TREATMENT

Jonathan W. Rucker, D.D.S.

An Abstract Presented to the Graduate Faculty of

Saint Louis University in Partial Fulfillment
of the Requirements for the Degree of
Master of Science in Dentistry

2012
 Abstract

Objective: To evaluate, over the first three weeks of

treatment, the differences in discomfort between Invisalign®

and fixed Damon appliances. Materials and Methods: A

prospective, longitudinal cohort study involving 60 adult

orthodontic patients (30 with Invisalign® and 30 with fixed

Damon appliances) was completed by using an electronic

survey. Treatment impacts were analyzed at four time

points: 24 hours, 1 week, 2 weeks, and 3 weeks after

starting orthodontic treatment. At each time point, the

patients were asked four discomfort related questions using

visual analog scale and three quality-of-life related

questions using a Likert scale. Results: The two treatment

groups showed baseline discomfort scores that were not

significantly different and did not change over time.

Consistent differences in discomfort were shown between

subjects treated with Invisalign® and fixed appliances

during the first week of treatment, with the greatest

differences reported 24 hours after the start of treatment.

The fixed appliance group reported a significantly (P<.05)

greater level of general discomfort related to orthodontic

appliances and greater discomfort when biting down on their

anterior and posterior teeth than the Invisalign® group. The

1
Invisalign® group experienced a statistically significant

increase in discomfort at two weeks, but there were no

group differences when compared to the fixed appliance

group. Subjects treated with fixed appliances also

reported taking significantly (P<.05) greater amounts of

medication to relieve pain associated with orthodontic

appliances. Differences in sleep interruptions were not

statistically significant between the groups. Conclusions:

Adults treated with fixed appliances experience a greater

level of discomfort and take more medications than adult

patients treated with Invisalign® aligners during the first

week of orthodontic treatment. Changing aligners at two

weeks has a small, but measurable, effect.

2
A PROSPECTIVE, LONGITUDINAL, STUDY OF INITIAL DISCOMFORT
ASSOCIATED WITH FIXED AND INVISALIGN TREATMENT

Jonathan W. Rucker, D.D.S.

A Thesis Presented to the Graduate Faculty of

Saint Louis University in Partial Fulfillment
of the Requirements for the Degree of
Master of Science in Dentistry

2012
 UMI Number: 1534373

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COMMITTEE IN CHARGE OF CANDIDANCY:

Adjunct Professor Peter H. Buschang,

Chairperson and Advisor

Professor Rolf G. Behrents

Professor Eustaquio Araujo

i
 DEDICATION

I dedicate this thesis to my family for their love and

support.

To my wife, Lissa, for her companionship and love

throughout the journey. For her commitment to education

and willingness to live as a student for so many years.

And for being a wonderful mother to our children.

To my two children, Kylea and Kade, for bringing

tremendous joy to my life each day.

ii
 ACKNOWLEDGEMENTS

I would like to thank the orthodontists and staff who

went out of their way to collect the data for this study,

namely the offices of Dr. David Paquette, Dr. Chris Klein,

Dr. David Sander, and Dr. Dave Ries.

Thank you to each member of my committee. Thanks to

Dr. Behrents for bringing humor into as many situations as

possible and keeping things lively. Thanks to Dr. Buschang

for seeing the value in my project and for his countless

hours in guiding my thesis each step of the way. A special

thanks to Dr. Araujo, who since our initial interview has

taken me in as his own. For his patience with me

throughout my education and being an example of great

character in his relationships with people. For his high

level of leadership, experience, and friendship. And most

importantly for his devoted and sincere interest in my

success.

iii
 TABLE OF CONTENTS

List of Tables..................................................v

List of Figures................................................vi

CHAPTER 1 : INTRODUCTION........................................1

CHAPTER 2 : REVIEW OF THE LITERATURE

Process of Pain.......................................3
Local Factors and Analgesics..........................4
Psychology of Pain....................................6
Measurement of Pain...................................6
Pain Progression, Acceptance, and Compliance..........8
Fixed vs. Removable...................................9
References...........................................13

CHAPTER 3 : JOURNAL ARTICLE

Abstract.............................................16
Introduction.........................................18
Materials and Methods................................20
Sample..........................................20
Statistical Analyses............................23
Results..............................................25
Group Descriptive Statistics....................25
Discussion...........................................37
Conclusions..........................................40
References...........................................42

Vita Auctoris..................................................43

iv
 LIST OF TABLES

Table 3.1 – Electronic survey questions .......................24

Table 3.2 – VAS scores describing baseline discomfort..........28

Table 3.3 – VAS scores describing general, anterior, and

posterior teeth discomfort .........................29
Table 3.4 – Likert scores describing sleep interruption and
medication taken ...................................32
Table 3.5 – Correlation between medication taken and
general, anterior, and posterior teeth
discomfort .........................................37

v
 LIST OF FIGURES

Figure 3.1 – VAS score baseline discomfort.....................28

Figure 3.2 – VAS score general teeth discomfort................30

Figure 3.3 – VAS score anterior teeth discomfort...............30

Figure 3.4 – VAS score posterior teeth discomfort..............31

Figure 3.5 – Likert score sleep interruption...................33

Figure 3.6 – Likert score tooth pain related medication........34

Figure 3.7 – Likert score non-tooth pain related medication....35

vi
 CHAPTER 1: INTRODUCTION

Pain and discomfort are common side-effects

experienced by a majority of patients treated with

orthodontic appliances.1,2 Studies have shown that

discomfort from orthodontic forces is a key discouraging

factor in patients deciding to start treatment.3 Discomfort

from orthodontic appliances has also been shown to

negatively impact compliance and treatment times.4

Furthermore, it has been shown that pain is a common reason

why patients often choose to interrupt or terminate their

treatment.5

On that basis, controlling pain and discomfort is

critical for patients undergoing orthodontic treatment,

especially when considering that appliances are expected to

be worn between 22-24 hours per day and often several

years. Control of pain and discomfort becomes even more

critical when the appliance can be removed by the patient.

If an appliance is significantly discomforting or painful

the patient may be less compliant with wearing the

appliance as instructed. Orthodontists must be able to

knowledgably inform their patients how much discomfort,

both in terms of intensity and duration, should be

1
anticipated by orthodontic appliances if treatment goals

are to be met.

Based on the foregoing, the primary purpose of the

present study was to compare pain and discomfort

experienced by patients treated with Invisalign® aligners to

those treated with fixed appliances (Damon System). The

secondary purpose was to evaluate difference in sleep

interruptions and pain medications used between the two

treatment approaches.

Four surveys were completed by each patient

participating in the study, evaluating changes in their

perceptions beginning the day after the orthodontic

treatment starts and over the following three weeks.

2
 CHAPTER 2 - REVIEW OF THE LITERATURE

Process of Pain

The process of pain can be identified as occurring in

four stages: transduction, transmission, perception, and

modulation. Transduction occurs when noxious stimuli are

detected by nociceptors that are located in skin, bones,

viscera and deep tissues. Nociceptors detect noxious

stimuli such as tissue damage and inflammation, also known

as endogenous stress factors. The activity detected by

nociceptors is transmitted through the neural pathway to

the brain where the information is perceived. Once the

pain signal is processed and modulated, the consequences

are expressed in various degrees of suffering and pain

behavior. These pain behaviors are measurable and provide

parameters for clinical assessment.6,7

Pain and discomfort from orthodontic forces follow the

pain process described previously. Discomfort caused by

orthodontic forces begins as a complex cellular response

within the periodontium. Furstman and Bernick8 suggest that

the experience of pain is initiated through a process of

pressure followed by ischemia, inflammation, and edema.

These changes in the periodontal ligament space are

3
detected by nociceptors, which transmit the noxious stimuli

to the brain where the information is perceived and

modulated. Therefore, the process of pain from orthodontic

forces begins at the cellular level when pressure creates

ischemic areas in the periodontal ligament and is

subsequently passed to the brain where the information is

processed and modulated.6,9,10

Local Factors and Analgesics

Studies have indicated that pain perception is

correlated with changes in blood flow as previously

indicated. Once ischemic areas are formed within the

periodontal ligament there is an increase in the presence

of local factors such as cytokines, growth factors and

other inflammatory stimuli. The presence of these local

factors stimulates the production of prostaglandins through

the cyclo-oxegenase-1 (COX-1) and cyclo-oxegenase-2 (COX-2)

pathways.6,9,10

Prostaglandins are important mediators of pain, fever,

and inflammation. Tissues that are not otherwise

responsive to pain become sensitive when there is an

increased presence of prostaglandins within the tissue.

Ferreira11 found that prostaglandins induce a hyperalgesic

4
effect by increasing sensitivity to noxious agents like

histamine, bradykinin serotonin, acetylcholine, and

substance P. Therefore, prostaglandins work primarily by

increasing the sensitivity of nociceptors to local factors

rather than directly activating nociceptors.6,9,10 Again,

these local changes are detected by nociceptors and

transmitted to the brain where the information is processed

and modulated. The subsequent consequences are expressed in

various degrees of suffering and pain behavior, which are

clinically measureable.6,7

There have been various modalities employed to

control pain caused by orthodontic forces. One such

modality is the use of non-steroidal anti-inflammatory

agents (NSAIDS), which are commonly prescribed to patients

experiencing orthodontic pain. The use of NSAIDs reduces

orthodontic pain by inhibiting the cyclo-oxegenase pathway

and effectively reduces prostaglandin synthesis.12

Furthermore, a recent meta-analysis found that over-the-

counter medications, such as NSAIDS, that inhibit or

suppress prostaglandins, effectively reduce orthodontic

pain.13 Although NSAIDs provide relief from orthodontic

pain, the level of pain relief that patients experience is

variable and depends on both the type and dose of

medication taken by the patient.

5
 Psychology of Pain

In addition to local noxious stimuli, some authors

have demonstrated psychological factors as be influential

in pain and discomfort experienced by patients treated with

orthodontic appliances.4,14,15 Psychological studies have

found that personal values and expectations of treatment

outcomes influence pain and discomfort experienced by the

patient.15,16 Psychological factors of particular importance

are the patients perceived severity of their malocclusions,

dental esthetics, and expectations of treatment outcomes.

These personal characteristics might also serve as

important motivational factors for patients seeking

orthodontic treatment.17,18,19 In conclusion, psychological

factors can influence pain and discomfort experienced by

orthodontic patients in addition to the effects produced by

local noxious stimuli.

Measurement of Pain

Once a pain signal is processed and modulated, the

consequences are expressed in various degrees of suffering

and pain behavior. These pain behaviors are measurable and

provide parameters for clinical assessment.6,7 Pain is a

6
multidimensional, complex, and multifactorial experience

that may be emotionally influenced, often making it

difficult to measure.20,21 However, studies have shown that

the visual analog scale (VAS) is a reliable method for

evaluating the pain experience.22,23,24

The visual analog scale (VAS) is traditionally

displayed as a horizontal line, 100 mm in length, and

anchored by two verbal descriptors at each extreme.

Subjects mark anywhere along the line to indicate the pain

or discomfort they are experiencing based on the particular

question being asked. The VAS score is determined by

measuring from the left side of the horizontal line to the

point where the patient made a mark. This concept is

easily understood by most patients experiencing pain.25

The method of administration of surveys is another key

factor in obtaining reliable data. An ideal pain intensity

scale must be easy to administer and the responses should

be easy to collect.25 Electronic surveys fit the criteria

in both ease of administration and collection while

providing the added advantages of being more cost

efficient, more legible, and providing the ability to more

easily track and collect responses. In conclusion, an

electronic version of the VAS provides an excellent tool

for measuring perception of pain.

7
 Pain Progression, Acceptance, and Compliance

The progression of pain after initiation of

orthodontic treatment has been well established. Several

studies have used VAS surveys to demonstrate the

progression of pain after initiating orthodontic forces.

Such studies have demonstrated that patients experience an

increase in pain within the first four hours after

placement of the initial archwire. This initial increase

in pain reaches a peak at 24 hours followed by a gradual

decrease until pain returns to baseline levels by day

seven.1,22,27-30 From these studies it can be concluded that

pain and discomfort begins within 24 hours after initial

archwire placement followed by an adjustment period of

seven days after the start of applied orthodontic force.

Appliance acceptance and patient compliance are

critical factors in treating patients with fixed and

removable appliances. Studies have shown that appliance

acceptance and compliance is directly correlated with pain

and discomfort. Sergl and Klages4 found a significant

correlation between patient compliance and appliance

acceptance during the first six months of orthodontic

treatment. These authors concluded that patients are less

compliant with appliances that are more discomforting. The

8
results of their study are in accord with the conclusion of

another study that found an association between discomfort

and patients’ expressed desire for early discontinuation of

orthodontic treatment.10 For these reasons, it is important

to better understand the intensity and duration of pain

experienced by patients being treated with fixed and

removable appliances; appliance acceptance and compliance

may be significantly affected.

Fixed vs. Removable

Several studies have described the pain and discomfort

experienced by patients treated with conventional, fixed

appliances. According to Kvam et al,9 95% of orthodontic

patients experience pain with a majority of these patients

experiencing a high intensity of pain. The same study also

found that while the majority of patients experience pain

lasting only a few days, some patients report constant pain

during the course of treatment. Jones and Chan1 reported

that, for some patients, pain experienced after initial

archwire placement may be greater than post-extraction

pain. There is no question that the intensity of pain and

discomfort significantly impact patients treated with

conventional, fixed appliances.

9
 There are a limited number of studies reporting pain

and discomfort experienced by patients treated with

removable appliances. Sergl and Klages4 used patient

questionnaires to study patient acceptance of removable

appliances during the first six months of orthodontic

treatment. Results of this study imply that patients adapt

to new orthodontic appliances, including removable

appliances, within the first seven days after appliance

insertion. These findings are consistent with the pattern

of pain progression established within the first week of

applied orthodontic force by fixed appliances.

Many patients are seeking the removable appliance

Invisalign® for their orthodontic treatment. One reason for

their interest in this appliance is they believe or have

been told that it is less painful or discomforting than

fixed appliance therapy. The only study that confirms this

concept was performed recently by Miller et al,31 which

compared the pain progression of patients treated with

traditional fixed appliances to those treated with

Invisalign®. This was a prospective, longitudinal cohort

study involving 60 adult orthodontic patients for whom pain

and discomfort were measured using surveys during the first

week of treatment. Subjects were instructed to complete

identical surveys for seven consecutive days. The survey

10
included 17 questions with only one asking about pain using

visual analog scale.

Results from this study confirmed the seven day pain

progression experienced by subjects treated with fixed and

removable appliances. In addition, Miller et al31 found

that the fixed appliance group reported a significantly

greater intensity of pain from days one through seven.

Pain level in the removable appliance group returned to

baseline levels by day seven, whereas pain level for the

fixed appliance groups did not completely return to

baseline by day seven. The authors concluded that subjects

treated with Invisalign® aligners experience an overall

better quality of life during the first week of orthodontic

treatment when compared to subjects treated with fixed

appliances.

While Miller et al31 described orthodontic pain

experienced by patients during the first week of

orthodontic treatment, their study may not fully explain

the pain experienced after the first week of treatment.

Although it has been established that discomfort falls to

near baseline levels within the first seven days, the study

does not take into account that Invisalign® is re-activated

every 14 days with the insertion of a new aligner.

Subjects treated with Invisalign® may experience an

11
increased frequency of pain progression compared to

subjects treated with fixed appliances as new aligners are

inserted every two weeks.

The study by Miller and colleagues may also be limited

in that the fixed appliance group included various types of

fixed appliance systems, which variation could produce

inconsistent results. Furthermore, subjects were taken

from a combination of multiple operators in private

orthodontic offices and a University. Variation with using

multiple private offices in combination with a University

setting could result in unpredictable psychological

influences.4,14,15,31 These factors may lead some readers to

question the validity of results found by the author.

The purpose of the present study was to compare pain

and discomfort experienced by patients treated with

Invisalign® aligners to those treated with fixed appliances

(Damon System). Orthodontists must be able to knowledgably

inform their patients as to how much discomfort, both in

terms of intensity and duration, that they should

anticipate if treatment goals are to be met. Understanding

the pain progression with Invisalign® beyond the first week

of treatment would be of value to the orthodontist in

educating patients about what to expect during the full

course of treatment.

12
 References

1. Jones M, Chan C. The pain and discomfort experienced

during orthodontic treatment: a randomized controlled
clinical trial of two initial aligning arch wires. Am J
Orthod Dentofacial Orthop 1992;102:373-81.

2. Kluemper GT. Efficacy of a wax containing benzocaine in

the relief of oral mucosal pain caused by orthodontic
appliances. Am J Orthod Dentofacial Orthop 2002;
122:359-65.

3. Oliver RG, Knapman YM. Attitudes to orthodontic

treatment. Br J Orthod 1985;12:179-88.

4. Sergl HG, Klages U, Zentner A. Pain and discomfort

during orthodontic treatment: causative factors and
effects on compliance. Am J Orthod Dentofacial Orthop
1998;114:684-91.

5. O'Connor PJ. Patients perceptions before, during, and

after orthodontic treatment. J Clin Orthod 2000;34:591-
92.

6. Kidd BL, Urban LA. Mechanisms of inflammatory pain. Br J

Anaesth 2001;87:3-11.

7. Loeser JD, Melzack R. Pain: an overview. Lancet

1999;353:1607-09.

8. Furstman L, Bernick S. Clinical considerations of the

periodontium. Am J Orthod Dentofacial Orthop
1972;61:138-55.

9. Kvam E, Gjerdet NR. Traumatic ulcers and pain during

orthodontic treatment. Community Dent Oral Epidemiol
1987;15:104-07.

10. White LW. Pain and cooperation in orthodontic treatment.

J Clin Orthod 1984;18:572-75.

11. Ferreira SH, Nakamura M, de Abreu Castro MS. The

hyperalgesic effects of prostacyclin and prostaglandin
E2. Prostaglandins 1978;16:31-7.

13
12. Chen L, Yang G, Grosser T. Prostanoids and inflammatory
pain. Prostaglandins Other Lipid Mediat 2012;12:116-5.

13. Angelopoulou MV, Vlachou V, Halazonetis DJ.

Pharmacological management of pain during orthodontic
treatment: a meta-analysis. Orthod and Cranio Research
2012;15:71-83.

14. Brown DF, Moerenhout RG. The pain experience and

psychological adjustment of orthodontic treatment of
preadolescents, adolescents, and adults. Am J Orthod
Dentofacial Orthop 1991;100:349-356.

15. Bandura A. Self-efficacy: toward a unifying theory of

behavioral change. Psychol Rev 1977;84:191-215.

16. Rotter JB. Generalized expectancies for internal versus

external control of reinforcement. Psychol Monogr
1966;80:1-28.

17. Mehra T, Nanda RS, Sinha PK. Orthodontists’ assessment

and management of patient compliance. Angle Orthod
1998;68:115-22.

18. Klages U. Development of a questionnaire for assessment

of the psychosocial impact of dental aesthetics in young
adults. Eur J Orthod 2006;28:103-11.

19. Slavkin HC. What we know about pain. J Am Dent Assoc

1996;127:1536-41.

20. Sessle BJ. The neurobiology of facial and dental pain:

present knowledge, future directions. J Dent Res
1987;66:962-81.

21. Merskey H. The perception and measurement of pain. J

Psychosom 1973;17:251-55.

22. Ngan P, Kess B, and Wilson S. Perception of discomfort

by patients undergoing orthodontic treatment. Am J
Orthod Dentofacial Orthop 1989;47-53.

23. Melzack R, Torgerson WS. On the language of pain.

Anesthesiology 1971;34:50-9.

24. Huskisson EC. Measurement of pain. Lancet 1974;2:1127-

31.

14
25. Jensen MP. The measurement of clinical pain intensity:
a comparison of six methods. Pain 1986;27:117-26.

26. Merskey H. The perception and measurement of pain. J

Psychosom Res 1973;17:251-55.

27. Wilson S, Ngan P, Kess B. Time course of the discomfort

in young patients undergoing orthodontic treatment.
Pediatr Dent 1989;11:107-10.

28. Scheurer PA, Firestone AR, Burgin WB. Perception of

pain as a result of orthodontic treatment with fixed
appliances. Eur J Orthod 1997;19:377-82.

29. Sergl HG, Klages U, Zentner A. Functional and social

discomfort during orthodontic treatment-effects on
compliance and prediction of patients’ adaptation by
personality variables. Eur J Orthod 2000;22:307-15.

30. Stewart FN, John W, Kerr S, Philip JS. Appliance wear:

the patient’s point of view. Eur J Orthod 1997;19:377-
82.

31. Miller KB. A comparison of treatment impacts between

Invisalign aligner and fixed appliance therapy during
the first week of treatment. Am J Orthod Dentofacial
Orthop 2007;131:302.e1-e9.

15
 CHAPTER 3: JOURNAL ARTICLE

Abstract

Objective: To evaluate, over the first three weeks of

treatment, the differences in discomfort between Invisalign®

and fixed appliances. Materials and Methods: A prospective,

longitudinal cohort study involving 60 adult orthodontic

patients (30 with Invisalign® and 30 with fixed Damon

appliances) was completed by using an electronic survey.

Treatment impacts were analyzed at four time points: 24

hours, 1 week, 2 weeks, and 3 weeks after starting

orthodontic treatment. At each time point, the patients

were asked four discomfort related questions using visual

analog scale and three quality-of-life related questions

using a Likert scale. Results: The two treatment groups

showed baseline discomfort scores that were not

significantly different and did not change over time.

Consistent differences in discomfort were shown between

subjects treated with Invisalign® and fixed appliances

during the first week of treatment, with the greatest

differences reported 24 hours after the start of treatment.

The fixed appliance group reported a significantly (P<.05)

greater level of general discomfort related to orthodontic

16
appliances and greater discomfort when biting down on their

anterior and posterior teeth than the Invisalign® group. The

Invisalign® group experienced a statistically significant

increase in discomfort at two weeks, but there were no

group differences when compared to the fixed appliance

group. Subjects treated with fixed appliances also

reported taking significantly (P<.05) greater amounts of

medication to relieve pain associated with orthodontic

appliances. Differences in sleep interruptions were not

statistically significant between the groups. Conclusions:

Adults treated with fixed appliances experience a greater

level of discomfort and take more medications than adult

patients treated with Invisalign® aligners during the first

week of orthodontic treatment. Changing aligners at two

weeks has a small, but measurable, effect.

17
 Introduction

Pain and discomfort are common side-effects

experienced by a majority of patients treated with

orthodontic appliances.1,2 Studies have shown that

discomfort from orthodontic forces is a key discouraging

factor in patients deciding to start treatment.3 Discomfort

from orthodontic appliances has also been shown to

negatively impact compliance and treatment times.4

Furthermore, it has been shown that pain is a common reason

why patients often choose to interrupt or terminate their

treatment.5

On that basis, controlling pain and discomfort is

critical for patients undergoing orthodontic treatment,

especially when considering that appliances are expected to

be worn between 22-24 hours per day and often several

years. Control of pain and discomfort becomes even more

critical when the appliance can be removed by the patient.

If an appliance is significantly discomforting or painful

the patient may be less compliant with wearing the

appliance as instructed. Orthodontists must be able to

knowledgably inform their patients how much discomfort,

both in terms of intensity and duration, should be

18
anticipated by orthodontic appliances if treatment goals

are to be met.

Based on the foregoing, the primary purpose of the

present study was to compare pain and discomfort

experienced by patients treated with Invisalign® aligners to

those treated with fixed appliances (Damon System). The

secondary purpose was to evaluate difference in sleep

interruptions and pain medications used between the two

treatment approaches.

There will be four surveys completed by each patient

participating in the study, evaluating changes in their

perceptions between the day after the orthodontic treatment

starts and three weeks thereafter.

19
 MATERIALS AND METHODS

Sample

A prospective, longitudinal cohort study involving 60

consecutive adult orthodontic patients (30 with Invisalign®

and 30 with fixed appliances) was completed by using an

electronic survey. Subjects from both groups were selected

for orthodontic treatment by four different orthodontists

practicing in four separate private orthodontic offices.

The subjects were selected based on the following criteria:

(1) at least 18 years of age, (2) to have received

treatment in both dental arches, (3) initial crowding

ranging from 2-7 mm per arch, (4) extractions not part of

the treatment plan during the survey period, but

interproximal reductions of up to 0.5 mm per contact were

acceptable. If the selection criteria were met and

subjects agreed to take part in the study, the orthodontic

office sent the principal investigator an email address and

expected start date of orthodontic treatment. The study

was approved by the Institutional Review Board of Saint

Louis University.

The fixed appliance group (30 subjects, 10 male and 20

female) was treated with the Damon System brackets and

20
.013-inch or .014-inch Damon copper nitinol wires (ORMCO).

The fixed appliances consisted of brackets and wires only.

This group did not include patients treated with skeletal

anchorage devices, functional appliances, elastics, or any

additional appliances during the survey period. The

removable appliance group (30 subjects, 14 male and 16

female) was treated with Invisalign® aligners. The

Invisalign® group was instructed to wear the appliance at

least 23 hours per day and a new aligner was to be inserted

every two weeks.

Four analogous post-appliance delivery surveys were

used to measure the effect of the appliances on patient

discomfort. An email containing a link to the survey was

sent to each subject participating in the study beginning

the day after the orthodontic treatment starting date.

This electronic survey delivery method was again employed

one, two and three weeks later, resulting in four

measurement occasions.

The survey consisted of seven questions (Table 3.1).

The first question was included to assess baseline

discomfort and to measure consistency between the answers

to each survey. This was followed by three discomfort

based treatment questions. All four questions were

answered using a 10 bubble long visual analog scale, with

21
“no discomfort” and “worst discomfort ever” as the anchors

at each extreme. There was one question that asked if the

appliance interfered with sleep, which was scored with a 4-

point Likert scale. Two questions asked what, if any, pain

medications were taken and scored with a 4-point Likert

scale. There were three additional questions asking the

gender, year of birth, and appliance type that the patient

was being treated with.

22
 Statistical Analyses

The pre- and post-treatment results were measured and

analyzed. All statistics calculated using SPSS software

version 18 (SPSS Inc., Chicago, Illinois). For the four

VAS measures, the groups were compared at each time point

using t-tests. Changes of the VAS measures within each

group were compared using paired t-tests. For the Likert

scores, the groups were compared using the non-parametric

Mann-Whitney test. Significance level was set at P <.05.

23
Table 3.1: Electronic survey questions

Measurement Question Possible Answers

VAS Rate the worst physical No discomfort → Worst

discomfort that you have ever discomfort ever
had in your entire life.

VAS Rate the level of discomfort No discomfort → Worst

that you are currently discomfort ever
experiencing with your braces or
Invisalign® treatment.

VAS While eating, how much No discomfort → Worst

discomfort do you experience discomfort ever
when you bite down on your front
teeth?

VAS While eating, how much No discomfort → Worst

discomfort are you experiencing discomfort ever
when you bite down on your back
teeth?

Likert Does discomfort caused by your Never, Sometimes, Often, Always

orthodontic appliance interfere
with your sleep?

Likert In the past 24 hours, how often Never, Sometimes, Often, Always
have you taken medication to
relieve tooth pain?

Likert In the past 24 hours, how often Never, Sometimes, Often, Always
have you taken medication to
relieve pain not associated with
tooth pain?

Direct What is your gender? Male, Female

Direct What orthodontic appliance do Invisalign®, Braces

you have?
Direct What year were you born 1950 → 1994

24
 Results

Group Descriptive Statistics

The two treatment groups showed baseline scores that

were not significantly different (p>.05) (Figure 3.1).

Repeated measures ANOVA showed no statistically significant

differences in reported baseline scores over the four time

points for either of the two groups.

There were no statistically significant differences in

the sex (P=.29) or age (P=.19) distributions between the

Invisalign® group and fixed appliance group. The three

questions evaluating discomfort consistently showed

differences between the Invisalign® group and fixed

appliance group during the first week of treatment (i.e.,

at 24 hours and at 1 week), with the greatest differences

reported 24 hours after the start of treatment. Both

groups experienced a peak in discomfort at 24 hours

followed by decreases in discomfort as treatment progressed

(Figures 3.2-3.4). The fixed appliance group reported a

significantly greater level of general discomfort 24 hours

and 1 week after starting orthodontic treatment when

compared to the Invisalign® group (Figure 3.2). The fixed

appliance group also experienced greater discomfort while

25
biting down on their anterior (Figure 3.3) and posterior

(Figure 3.4) teeth. For all three of these measures, the

group differences were statistically significant both at 24

hours and one week after starting orthodontic treatment.

The group differences two and three weeks after the start

of orthodontic treatment were not statistically

significant. The Invisalign® group showed a statistically

significant increase in discomfort at two weeks for three

of the measures, even though the group differences were not

significant (Fig 3.2-3.4).

Both groups experienced decreases in sleep

interruptions between 24 hours and 3 weeks (Figure 3.5).

The group differences in interferences with sleep

approached a significant level at 24 hours.

Subjects treated with fixed appliances reported taking

statistically significant greater amounts of medication to

relieve pain associated with orthodontic appliances at 24

hours and 1 week after starting treatment. The greater

amounts of pain medication taken by the fixed appliance

group also correlated with general, anterior, and posterior

teeth discomfort at 24 hours and 1 week after starting

treatment (Table 3.5). Over 70% of the Invisalign® subjects

reported taking no medication 24 hours after starting

treatment, whereas over 70% of the fixed appliance group

26
were taking medications sometimes (40%) or often (30%).

Similarly, only 3.3% of the Invisalign® patients took

medication sometimes after one week, whereas 23.3% and 3.3%

of those treated with fixed appliances reported taking

medications sometimes or often, respectively (Figure 3.6).

There were no statistically significant group differences

in the amounts of medication taken for discomfort that was

not related to tooth pain (Figure 3.7).

27
Table 3.2: VAS scores describing baseline discomfort of the Invisalign® group
and fixed appliance group at 24 hours, 1 week, 2 weeks, and 3 weeks

Invisalign® Fixed Appliance Prob.

Time Mean SD Mean SD Diff.

24 hrs 8.37 1.83 9.10 1.06 .134

1 wk 8.63 1.50 9.20 1.10 .111

2 wks 8.83 1.15 9.33 0.88 .084

3 wks 8.67 1.27 9.10 1.06 .192

Figure 3.1 – VAS score describing baseline discomfort “Rate the worst
physical discomfort that you have ever had in your entire life” evaluated at
four time points

28
 Table 3.3: VAS scores describing general discomfort, anterior teeth discomfort, and posterior teeth discomfort
of the Invisalign® group and fixed appliance group evaluated at 24 hours, 1 week, 2 weeks, and 3 weeks

Invisalign® Fixed Appliance Prob.

Question Time Mean SD Mean SD Diff.

24 hrs 2.93 1.08 4.30 1.51 ≤.001 ***

with your braces
Rate the level

or Invisalign®
of discomfort
that you are

experiencing

1 wk 2.33 1.12 3.27 1.41 .002 **

currently

treatment

2 wks 2.57 1.07 2.50 1.01 .757

3 wks 2.27 0.91 2.00 0.74 .284

24 hrs 3.23 1.74 5.17 1.95 ≤.001 ***

29

you experiencing
discomfort are
While eating,

when you bite

down on your
front teeth?

1 wk 2.77 1.17 3.83 1.91 .030 *

how much

2 wks 3.10 1.49 2.97 1.67 .651

3 wks 2.50 1.04 2.47 1.38 .560

24 hrs 3.13 2.00 4.37 2.24 .019 *

you experiencing
discomfort are
While eating,

when you bite

down on your

1 wk 2.33 1.52 3.27 1.39 .005 **

back teeth?
how much

2 wks 2.70 1.49 2.33 1.24 .386

3 wks 1.93 0.78 1.93 0.74 .832

*** indicates P≤.001

** indicates P≤.01
* indicates P≤.05
 *** indicates P≤.001
** indicates P≤.01
* indicates P≤.05

Figure 3.2 – VAS score describing general teeth discomfort “Rate the level of
discomfort that you are currently experiencing with your braces or Invisalign®
treatment” evaluated at four time points

*** indicates P≤.001

** indicates P≤.01
* indicates P≤.05

Figure 3.3 – VAS score describing anterior teeth discomfort “While eating, how
much discomfort are you experiencing when you bite down on your front teeth?”
evaluated at four time points

30
 *** indicates P≤.001
** indicates P≤.01
* indicates P≤.05

Figure 3.4 – VAS score describing posterior teeth discomfort “While eating, how
much discomfort are you experiencing when you bite down on your back teeth?”
evaluated at four time points

31
 Table 3.4: Likert scores describing sleep interruption and medication taken by the Invisalign® group and fixed
appliance group evaluated at 24 hours, 1 week, 2 weeks, and 3 weeks

Invisalign® Fixed Appliance Prob.

Question Time point Median IQR Median IQR Diff.

50th 25th,75th 50th 25th,75th

24 hrs 0 0,0 0 0,1 .055

Does discomfort
caused by your

interfere with

1 wk 0 0,0 0 0,0 .259

orthodontic

your sleep?
appliance

2 wks 0 0,0 0 0,0 .317

3 wks 0 0,0 0 0,0 .317

32

24 hrs 0 0,1 1 0,2 <.001 ***

hours, how often
In the past 24

have you taken

medication to
relieve tooth

1 wk 0 0,0 0 0,1 .012 *

2 wks 0 0,0 0 0,0 1.000

pain?

3 wks 0 0,0 0 0,0 1.000

24 hrs 0 0,0 0 0,0 .557

hours, how often

relieve pain not

associated with
In the past 24

have you taken

medication to

1 wk 0 0,0 0 0,0 .557

tooth pain?

2 wks 0 0,0 0 0,0 .040 *

3 wks 0 0,0 0 0,0 1.000

*** indicates P≤.001

* indicates P≤.05
33

Figure 3.5 – Likert score describing sleep interruption “Does discomfort caused by your orthodontic appliance
interfere with your sleep?” evaluated at four time points
34

Figure 3.6 – Likert score describing tooth pain related medication taken “In the past 24 hours, how often have
you taken medication to relieve tooth pain?” evaluated at four time points
35

Figure 3.7 – Likert score describing non-tooth pain related medication taken “In the past 24 hours, how often
have you taken medication to relieve pain not associated with tooth pain?” evaluated at four time points
 Table 3.5: Correlations between reported medication taken to relieve tooth pain and general teeth discomfort,
anterior teeth discomfort, and posterior tooth discomfort of the Invisalign® group and fixed appliance group
evaluated at 24 hours and 1 week

Invisalign® Fixed Appliance

Question Time r p r p
discomfort that you
Rate the level of

experiencing with

24 hrs .186 .326 .615 <.001 ***

your braces or
are currently

Invisalign®
treatment

1 wk -.037 .845 .535 .002 **

36

you experiencing

24 hrs .408 .025 * .615 <.001 ***

discomfort are
While eating,

when you bite

down on your
front teeth?
how much

1 wk -.133 .483 .417 .022 *

you experiencing

24 hrs .193 .307 .533 .002 **

discomfort are
While eating,

when you bite

down on your
back teeth?
how much

1 wk -.224 .234 .547 .002 **

*** indicates P≤.001

** indicates P≤.01
* indicates P≤.05
 Discussion

The progression of pain after the initiation of orthodontic

treatment1,4,6,8-10 has been well established and recognized that

pain peaks at 24 hours.1,8,9 Both groups in this study

experienced a peak in discomfort at 24 hours followed by a

decrease as treatment progressed between 24 hours to 3 weeks

(Figures 3.2-3.4).

The initial discomfort was significantly greater for those

in fixed appliances. These results are consistent with previous

studies that have compared the differences in discomfort between

fixed appliances compared with removable appliances. Scheurer

et al9 found that for patients treated with fixed appliances,

eating has the greatest impact on quality of life. Oliver and

Knapman3 found that the appearance of fixed appliances to be a

major factor during treatment. Other explanations for

differences in discomfort between the groups have been

attributed to the smaller size of Invisalign®, lack of sharp

edges, and the ability to remove the Invisalign® appliance for

hygiene. These factors likely increase the patient’s quality of

life when treated with Invisalign®.6,10

Subjects treated with Invisalign® experienced a change in

discomfort at 2 weeks, which is consistent with the insertion of

new aligners. Although the changes were small and no group

37
differences were found, changes in discomfort were statistically

significant. The author believes that group differences may be

found with a larger sample size.

Although the differences did not attain statistical

significance, the fixed appliance group experienced greater

interference with sleep. This difference was again most notable

between 24 hours and 1 week. Both groups experienced a steady

improvement in sleep interruption as treatment time progressed.

These findings are consistent with the literature for fixed

appliances.10,11 No other study has investigated sleep

interruption with Invisalign® therapy.

An increase in pain medication taken by the fixed appliance

group correlated with an increased discomfort level reported for

general, anterior, and posterior teeth discomfort (Table 3.5).

Subjects treated with fixed appliances reported taking greater

amounts of medication to relieve pain associated with

orthodontic appliances at 24 hours and 1 week after starting

treatment. These findings agree with other studies comparing

fixed and removable appliances.1,7-9 Miller et al6 in comparing

subjects treated fixed appliances to those treated with

Invisalign® also found that pain medication intakes peaked at 24

hours and the consumption was greater for those treated with

fixed appliances. The results of this study confirm what other

38
studies have found in regards to pain medication consumed by

patients treated with orthodontic appliances.

Several factors may explain the lower intensity of pain and

discomfort experienced by the Invisalign® group. The amount of

tooth movement for each activation period of two weeks is pre-

determined by Invisalign® and is likely to be much less when

compared to fixed appliances. The Invisalign® appliance may also

demonstrate a less consistent force over each activation period.

This is probably due to the stretching and absorption of water

of the Invisalign® material over time. Also, unlike the fixed

appliance group, subjects treated with Invisalign® had the

ability to remove the appliance at the peak of discomfort.

The present study reports a lower intensity of discomfort

for both the Invisalign® and fixed appliance groups when compared

to the study by Miller et al6. The statistical method in

reporting pain in the study by Miller et al6 may explain this

difference as the data were not normally distributed, which

could lead to artificially inflated values.

39
 Conclusions

According to the results of this study, adult orthodontic

patients treated with Invisalign® and fixed appliance therapies

demonstrated the following differences:

1) Consistent differences in discomfort were shown between

Invisalign® and fixed appliances during the first week of

treatment, with the greatest differences reported 24 hours after

the start of treatment.

2) The fixed appliance group reported a significantly

greater level of general discomfort than the Invisalign® group 24

hours and 1 week after starting orthodontic treatment. Both

groups experienced a decrease in discomfort as treatment

progressed between 24 hours to 3 weeks.

3) The fixed appliance group experienced a significantly

greater level of discomfort while biting down on their anterior

and posterior teeth 24 hours and 1 week after starting

orthodontic treatment.

4) The slight increases in discomfort experienced by the

Invisalign® group, between the first and second weeks, correlated

with the insertion of a new Invisalign® aligner. The changes in

40
discomfort were statistically significant, but no group

differences were found.

5) Although the differences did not attain statistical

significance, the fixed appliance group experienced greater

interference with sleep. This difference was again most notable

between 24 hours and 1 week. Both groups experienced decreases

in sleep interruptions between 24 hours and 3 weeks.

6) Subjects treated with fixed appliances reported taking

statistically significant greater amounts of medication to

relieve pain associated with orthodontic appliances at 24 hours

and 1 week after starting treatment. The greater amounts of

pain medication taken by the fixed appliance group also

correlated with general, anterior, and posterior teeth

discomfort at 24 hours and 1 week after starting treatment.

41
 References

1. Jones M, Chan C. The pain and discomfort experienced during

orthodontic treatment: a randomized controlled clinical trial
of two initial aligning arch wires. Am J Orthod Dentofacial
Orthop 1992;102:373-81.

2. Kluemper GT. Efficacy of a wax containing benzocaine in the

relief of oral mucosal pain caused by orthodontic appliances.
Am J Orthod Dentofacial Orthop 2002; 122:359-65.

3. Oliver RG, Knapman YM. Attitudes to orthodontic treatment. Br

J Orthod 1985;12:179-88.

4. Sergl HG, Klages U, Zentner A. Pain and discomfort during

orthodontic treatment: causative factors and effects on
compliance. Am J Orthod Dentofacial Orthop 1998;114:684-91.

5. O'Connor PJ. Patients perceptions before, during, and after

orthodontic treatment. J Clin Orthod 2000;34:591-92.

6. Miller KB. A comparison of treatment impacts between

Invisalign aligner and fixed appliance therapy during the
first week of treatment. Am J Orthod Dentofacial Orthop
2007;131:302.e1-e9.

7. Erdinc AM and Dincer B. Perception of pain during orthodontic

treatment with fixed appliances. Eu J Orthod 2004;26:79-85.

8. Ngan P, Kess B, and Wilson S. Perception of discomfort by

patients undergoing orthodontic treatment. Am J Orthod
Dentofacial Orthop 1989;47-53.

9. Scheurer PA, Firestone AR, Burgin WB. Perception of pain as

a result of orthodontic treatment with fixed appliances. Eur
J Orthod 1997;19:377-82.

10. Stewart FN, John W, Kerr S, Philip JS. Appliance wear: the
patient’s point of view. Eur J Orthod 1997;19:377-82.

11. Wu AK, McGrath C, Wong RW, Wiechmann D. A comparison of pain

experienced by patients treated with labial and lingual
orthodontic appliances. Eur J Orthod 2010;32:403-7.

42
 VITA AUCTORIS

Jonathan Wade Rucker was born on July 20th, 1982 in Orange,

California to Bruce Leonard Rucker and Marcy Ann Rucker. He is

the third of five boys.

He was raised in Palm Desert, California and graduated from

Palm Desert High School in May 2000. He attended Brigham Young

University-Hawaii in Laie, Hawaii and later Brigham Young

University in Provo, Utah, where he obtained a Bachelor of

Science degree in June 2006. He obtained his Doctor of Dental

Surgery from Virginia Commonwealth University in 2010. In June

2010, he began his orthodontic residency program at Saint Louis

University, Center for Advanced Dental Education, where he

expects to receive a Master of Science in Dentistry in December

2012.

Jonathan met his wife, Lissa, while attending Brigham Young

University-Hawaii in September 2000. They were married on June

26, 2004 in La Jolla, California. They have two children, Kylea

and Kade. Upon graduation, they plan to move to Palm Desert,

California where Jonathan will enter private practice.

43