Factors Associated With Pain Level Experience in Orthodontic Treatment
Conditions: Orthodontic Pain, Pain, Orthodontic Appliance Complication
Sponsor: Chia Jung Lee

 
 
 
 
 
 
 
 
 
 
 
 
Official title of the study: 
 
Factors Associated with Pain Level 
Experience During Orthodontic 
Treatment 
 
NCT number: Not Available  
 
Date of the document: 04 February 2021

 
Research Proposal 
Research title Factors Associate to Pain Level Experience during Orthodontic treatment 
Main 
Investigator 
CHIA JUNG, LEE 
Abstract 
Orthodontic pain has been the primary concern from all patients who 
requires orthodontic treatment. The design of the study will help us 
comprehend how patient experienced and managed pain during their 
orthodontic treatment, average pain level in different orthodontic 
appliances and factors that could affect pain level experience during 
treatment, including gender, age, braces types, hygiene level and 
habitude. With this research, we can interpret the average pain level 
experience in orthodontic treatment from the survey and clinical data 
collected and find correlations within each individual respective of 
different pain level. 
Research 
background 
& Discussion 
• Since orthodontic pain has been the primary concern for patient, a 
thorough investigation for the pain level experience and it’s factors 
related could help us explain to the patient better before starting their 
treatment, giving information of the general pain level and on what 
circumstances will patient experience more or less pain. 
• There are various clinical studies, literature reviews and hypothesises 
regarding to different factors that could or could not affect the experience 
the pain level during orthodontic treatment. Factors such as, type of 
orthodontic appliances (MBT, self-ligated, Invisalign), gender, age, 
depression history, hygiene level…. were mentioned in different 
literature that it could affect their pain perception. 
• This study is to conclude and correlate factors that could affect one’s pain 
perception during orthodontic treatment 
 
Objective & 
Hypothesis 
of the 
research 
• The main objective is to compare pain level between different 
orthodontic appliances (MBT, self-ligated, Invisalign)  
• The secondary objective is to compare pain level within different factors 
such as gender, age, history of masticatory pain, history of depression, 
hygiene level and habitude. 
• The hypothesis of the research is that different pain level is multifactored 
and with different appliance, age, gender, the pain level could be more 
alleviated or intense.  
Methodology • Study type: Observational 
• Cross-sectional analysis of participants who received orthodontic 
treatment from UAX Innovation and Advanced Specialty Clinic. 
• Inclusion criteria:  
-Patient with orthodontic treatment over 2 months and less than 18 
months 
-Patient with braces or Invisalign 
-Patient who goes to orthodontic visit routinely 
• Exclusion criteria: 
-Patient undergoing ONLY orthopaedic treatment (functional 
appliances, 2x4 braces placement, maxillary expansion device) 
-Patient who does not understand Spanish 

 
-Patient with cognitive impairment 
-Patient who does not want to participate in the study 
-Patient who has compete their orthodontic treatment 
• A simple random sampling of orthodontic patients who attended 
periodically. Each consultation was carried out by a total of 12 dentist 
with more than 2 years of clinical practice experiences and who agreed to 
pass on their patient’s clinical reports to gather their information. 
• The minimum sample size for the study was determined in 150 
participants 
• Consent form (Jotform) and Survey (Surveyhero) was generated as a link 
and sent to each participant through Whatsapp to complete online. 
• Questionnaire was assessed through GESIS survey guideline to ensure 
the efficacy of each questions and quality of the survey data. 
• The outcome measure of the pain level experience is based on visual 
analogue scale (VAS)  
Planning for 
the analysis 
of the result 
• Expectation: Study showed that: 
-Invisalign treatment exhibit the least pain out of all kinds of orthodontic 
appliances.  
-Women tend to tolerate less the pain (hence higher pain level) 
-Age has no influence in different pain level experience during 
orthodontic treatment 
-History of depression could have higher pain level 
• The limitations of the research were:  
-The ethnicity of the participants were mainly Spanish 
-The participants for Invisalign treatment in general are elder patients, 
and the older the pain the better pain tolerance they have. 
-Perception of pain varies between each individual (inter-individual 
variability), it could be interpreted by different perspective biologically 
and psychologically. 
Expectation 
of the 
research 
Hypothetically based on different studies: 
-Invisalign treatment exhibit the least pain out of all kinds of orthodontic 
appliances.  
-Women tend to tolerate less the pain (hence higher pain level) 
-Age has no influence in different pain level experience during 
orthodontic treatment 
-History of depression could have higher pain level 
Bibliographic 
reference  
1) Scheurer PA, Firestone AR, Bürgin WB. Perception of pain as a result 
of orthodontic treatment with fixed appliances. Eur J Orthod. 1996 
Aug;18(4):349-57. PubMed 8921656  
2) Cardoso PC, Espinosa DG, Mecenas P, Flores-Mir C, Normando D. 
Pain level between clear aligners and fixed appliances: 
a systematic review. Prog Orthod. 2020 Jan 20;21(1):3. doi: 10.1186/ 
s40510-019-0303-z. PubMed 31956934  
3) Krukemeyer AM, Arruda AO, Inglehart MR. Pain and orthodontic 
treatment. Angle Orthod. 2009 Nov;79(6):1175-81. doi: 
10.2319/121308-632R.1. PubMed 19852612  
4) Banerjee S, Banerjee R, Shenoy U, Agarkar S, Bhattacharya S. Effect 
of orthodontic pain on quality of life of patients undergoing 

 
orthodontic treatment. Indian J Dent Res. 2018 Jan-Feb;29(1):4-9. 
doi: 10.4103/ ijdr.IJDR_113_16. PubMed 29442079  
5) Kafle D, Rajbhandari A. Anticipated pain and pain experience among 
orthodontic patients: is there any difference? Kathmandu Univ Med 
J (KUMJ). 2012 Apr-Jun;10(38):71-3. PubMed 23132480  
6) Nicotra C, Polizzi A, Zappalà G, Leonida A, Indelicato F, Caccianiga G. 
A Comparative Assessment of Pain Caused by the Placement of 
Banded Orthodontic Appliances with and without Low-Level Laser 
Therapy: A Randomized Controlled Prospective Study. Dent J (Basel). 
2020 Mar 4;8(1). pii: E24. doi: 10.3390/dj8010024. PubMed 
32143365  
7) Campbell P, Jordan KP, Smith BH, Scotland G, Dunn KM. Chronic pain 
in families: a cross-sectional study of shared social, behavioural, and 
environmental influences. Pain. 2018 Jan;159(1):41-47. doi: 
10.1097/j.pain.0000000000001062. PMID: 28937576; PMCID: 
PMC5737454. 
8) Fillingim RB. Individual differences in pain: understanding the mosaic 
that makes pain personal. Pain. 2017 Apr;158 Suppl 1(Suppl 1):S11-
S18. doi: 10.1097/j.pain.0000000000000775. PMID: 27902569; 
PMCID: PMC5350021. 
9) https://www.physio-pedia.com/Visual_Analogue_Scale Description 
The Visual analogue Scale (VAS) for pain assessment  
10) https://eu.jotform.com/myforms/? Description Online consent form 
for the survey  
11) https://www.surveyhero.com 
Description Questionnaire designed and distributed through this 
website  
Research 
programme 
• Time frame: From 4th of February 2021 to 31st of March 2022 
• Investigator: Chia Jung, Lee 
• Resources: UAX clinic, Textbooks, Pubmed, Research gate 
• Auxiliary tools: Jotform (consent form), Surveyhero (questionnaire)  
• Estimate cost: Around 1700 euros  
-Annual fee for the survey form  
-Orthodontic cleaning kits (For the raffle) 
-Fee for ethical committee of Spain approval  
Appendices 
Attachment below: 
• Questionnaire 
 
 
 
 
 
 
 
 
 
 
 

 
Questionnaire Title:  
Pain Level Experience during Orthodontic Treatment 
Survey questions: 
 
Full Name (First and Last name):__________ 
1) What is your gender?  
a. Male 
b. Female 
2) What is your age? ________ 
3) What is your estimate orthodontic treatment time? 
a. 6 months 
b. 12months 
c. 18months 
d. 24months 
e. 30months 
4) What kind of treatments are done or expected to be done? (multiple choices) 
a. Metallic or aesthetic Braces 
b. Clear aligner (Invisalign) 
c. Extractions of teeth 
d. Interproximal reduction (stripping of teeth) 
e. Elastic placement (Doctor assigned me to do daily) 
5) Do you have history of anxiety or depression? 
a. Yes 
b. No 
6) Do you smoke? 
a. Yes  
b. No 
7) Are you on prescription of any medication in general? What is the name of the 
medication? (If you are NOT on any prescription medication you can skip the 
question): ______________ 
8) Do you normally have masticatory muscle pain or grind your teeth at night? 
a. Yes  
b. No 
9) On what occasion do you clean your teeth? 
a. Only in the morning 
b. Only at night 
c. Morning & Night 
d. Morning & Night & every time after meal 
10) Does your gum bleed whiles brushing?  
a. Yes  
b. Sometime 
c. No 
 
 
 
 
Option e  

 
11) From 0-10, how was the initial pain after the appointment of bracket cementation 
or your first Invisalign retainer? ____ 
 
 
 
 
 
 
 
 
 
 
12) Which day after the INICIAL braces cementation you experience the most intense 
pain? 
a. 1st day 
b. 2nd day 
c. 3rd day 
d. 1st week in general 
e. 1st +2nd week 
13) Which day after the INICIAL braces cementation your pain was alleviated?  
(The previous question was: Which day after the INICIAL braces cementation you 
experience the most intense pain?) 
a. 1st day 
b. 2nd day 
c. 3rd day 
d. 1st week in general 
e. 1st +2nd week 
14) From 0-10, how was the pain after every orthodontic visit when new arch wires are 
placed or when new Invisalign retainers are changed? ______ 
 
 
 
 
 
 
 
 
 
 
15)  Which day after the regular visit you experience the most intense pain? 
a. 1st day 
b. 2nd day 
c. 3rd day 
d. 1st week in general 
e. 1st +2nd week 
 
 

 
16) Which day after the regular visit your pain is alleviated? 
(The previous question was: Which day after the regular visit you experience the 
most intense pain?) 
a. 1st day 
b. 2nd day 
c. 3rd day 
d. 1st week in general 
e. 1st +2nd week 
17) When you had pain during orthodontic treatment, did you take analgesics?  
a. Yes (Include sometimes)  
b. No 
18) At which moment do you normally take the analgesic? (Multiple choices) 
(The previous question was: When you had pain during orthodontic treatment, did 
you take analgesics? ) 
a. The first few day (Initial of treatment) after braces were placed 
b. After each regular visits when arch wires are changed or new Invisalign 
retainer was changed 
c. Other reasons (tooth extractions, headache, back pain, TMJ pain, masticatory 
muscle pain) 
19) If you had taken analgesic, what is the name of the analgesic? ___________ 
(The previous question was: At which moment do you normally take the analgesic?) 
20) Did the pain relieve after intaking the analgesic? 
(The previous question was: If you had taken analgesic, what is the name of the 
analgesic?) 
a. Yes 
b. No 
21) In general do you find orthodontic a painful treatment? Grade it from 0-10______ 
 
 
 
 
 
 
 
 
 
 
22) Are you satisfied with your orthodontic treatment at the moment? Grade 0-5: ___ 
23) Do you have any suggestions regarding to your orthodontic treatment to help us 
improve? 
24) Would you like to join the raffle and win an orthodontic cleaning kit? 
a. Yes and please inform me! 
b. No, thank you J 
 
 
 
Thank you for your participation, we really appreciate you help!