- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05361616
Impact of Photobiomodulation on Pain During Orthodontic Treatment.
Impact of Photobiomodulation on Pain During Orthodontic Treatment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tarek El-Bialy, PhD
- Phone Number: 7806953110
- Email: telbialy@ualberta.ca
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T5K 2L2
- Recruiting
- Sphinx Orthodontic
-
Contact:
- Tarek El-Bialy, PhD
- Phone Number: 7806953110
- Email: telbialy@ualberta.ca
-
Edmonton, Alberta, Canada, T6G 1Z1
- Recruiting
- Orthodontic Graduate Clinic, Kaye Clinic, University of Alberta
-
Contact:
- Tarek El-Bialy, PhD
- Phone Number: 7806953110
- Email: telbialy@ualberta.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Systemically healthy male and female patients (age 20 to 65), i.e., do not suffer from systemic illness nor require medication during the saliva collection period.
- Permanent dentition, with Little's Irregularity Index (LII) of 2 mm or greater for the upper and lower arch.
- Orthodontic treatment using clear aligners via non-extraction therapy.
- Patient is available for follow-up visits.
- Patient is able and willing to comply with the requirements of this trial protocol.
- Non-smoker with no use of chewing tobacco.
- Good oral hygiene.
- Caries free.
- No sign of periodontal disease.
Exclusion Criteria:
- Systemic diseases
- Medication use for the past 6 months; specially use of anti-inflammatory (e.g., NSAIDs), antiviral, antibiotics.
- Smoking.
- Active dental caries.
- Any periodontal problem including bleeding, tooth mobility, bone loss, attachment loss, deep pockets.
- Sleep apnea and other airway pathologies.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: PBM Ortho Active device
PBM Ortho Active group will be given an active device.
|
The device will be used by the patients at home for one 8 minutes per day (4 minutes each upper and lower) for 7 days.
|
Sham Comparator: PBM Ortho Sham
PBM Ortho Sham device group will be given a non-active device that will not emits light.
|
The device will be used by the patients at home for one 8 minutes per day (4 minutes each upper and lower) for 7 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analog scale
Time Frame: Day 0: prior to seating first clear aligner tray
|
Study endpoint for effectiveness in decreasing the pain perception during orthodontic tooth movement.
Pain intensity will be scored between 0 (no pain) and 10 (worst imaginable pain) on the numeric scale.
Pain intensity does not have a unit to describe.
The pain intensity will be recorded in both groups at Day 0 (after the placement of the first composite attachments on the teeth but before the seating of the first clear aligner), and then every day for 7 consecutive days.
|
Day 0: prior to seating first clear aligner tray
|
Visual analog scale
Time Frame: Day 1
|
Study endpoint for effectiveness in decreasing the pain perception during orthodontic tooth movement.
Pain intensity will be scored between 0 (no pain) and 10 (worst imaginable pain) on the numeric scale.
Pain intensity does not have a unit to describe.
The pain intensity will be recorded in both groups at Day 0 (after the placement of the first composite attachments on the teeth but before the seating of the first clear aligner), and then every day for 7 consecutive days.
|
Day 1
|
Visual analog scale
Time Frame: Day 2
|
Study endpoint for effectiveness in decreasing the pain perception during orthodontic tooth movement.
Pain intensity will be scored between 0 (no pain) and 10 (worst imaginable pain) on the numeric scale.
Pain intensity does not have a unit to describe.
The pain intensity will be recorded in both groups at Day 0 (after the placement of the first composite attachments on the teeth but before the seating of the first clear aligner), and then every day for 7 consecutive days.
|
Day 2
|
Visual analog scale
Time Frame: Day 3
|
Study endpoint for effectiveness in decreasing the pain perception during orthodontic tooth movement.
Pain intensity will be scored between 0 (no pain) and 10 (worst imaginable pain) on the numeric scale.
Pain intensity does not have a unit to describe.
The pain intensity will be recorded in both groups at Day 0 (after the placement of the first composite attachments on the teeth but before the seating of the first clear aligner), and then every day for 7 consecutive days.
|
Day 3
|
Visual analog scale
Time Frame: Day 4
|
Study endpoint for effectiveness in decreasing the pain perception during orthodontic tooth movement.
Pain intensity will be scored between 0 (no pain) and 10 (worst imaginable pain) on the numeric scale.
Pain intensity does not have a unit to describe.
The pain intensity will be recorded in both groups at Day 0 (after the placement of the first composite attachments on the teeth but before the seating of the first clear aligner), and then every day for 7 consecutive days.
|
Day 4
|
Visual analog scale
Time Frame: Day 5
|
Study endpoint for effectiveness in decreasing the pain perception during orthodontic tooth movement.
Pain intensity will be scored between 0 (no pain) and 10 (worst imaginable pain) on the numeric scale.
Pain intensity does not have a unit to describe.
The pain intensity will be recorded in both groups at Day 0 (after the placement of the first composite attachments on the teeth but before the seating of the first clear aligner), and then every day for 7 consecutive days.
|
Day 5
|
Visual analog scale
Time Frame: Day 6
|
Study endpoint for effectiveness in decreasing the pain perception during orthodontic tooth movement.
Pain intensity will be scored between 0 (no pain) and 10 (worst imaginable pain) on the numeric scale.
Pain intensity does not have a unit to describe.
The pain intensity will be recorded in both groups at Day 0 (after the placement of the first composite attachments on the teeth but before the seating of the first clear aligner), and then every day for 7 consecutive days.
|
Day 6
|
Visual analog scale
Time Frame: Day 7
|
Study endpoint for effectiveness in decreasing the pain perception during orthodontic tooth movement.
Pain intensity will be scored between 0 (no pain) and 10 (worst imaginable pain) on the numeric scale.
Pain intensity does not have a unit to describe.
The pain intensity will be recorded in both groups at Day 0 (after the placement of the first composite attachments on the teeth but before the seating of the first clear aligner), and then every day for 7 consecutive days.
|
Day 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Saliva analysis
Time Frame: The saliva will be collected on Day 0
|
2 ml of saliva samples will be obtained from all the patients enrolled in the study at Day 0, Day 1, Day 4 and Day 7 time points in 15-ml Falcon tubes. The samples will be immediately frozen and stored at -80°C refrigerator until assayed. Multiplex immunoassay will be used to analyze target proteins: cortisol, testosterone, alpha amylase, interleukin 1β (IL-1β), prostaglandin E2 (PGE2), receptor activator of nuclear factor kappa-B ligand (RANKL), nerve growth factor (NGF), brain derived neurotrophic factor (BDNF), substance P (SP), macrophage inflammatory protein-4 (MIP-4), matrix metalloproteinase-8 (MMP-8). ELISA kits for each target protein will be utilized to quantify the protein in the saliva and the unit will be according to the protocol provided in the kit. |
The saliva will be collected on Day 0
|
Saliva analysis
Time Frame: The saliva will be collected on Day 1
|
2 ml of saliva samples will be obtained from all the patients enrolled in the study at Day 0, Day 1, Day 4 and Day 7 time points in 15-ml Falcon tubes. The samples will be immediately frozen and stored at -80°C refrigerator until assayed. Multiplex immunoassay will be used to analyze target proteins: cortisol, testosterone, alpha amylase, interleukin 1β (IL-1β), prostaglandin E2 (PGE2), receptor activator of nuclear factor kappa-B ligand (RANKL), nerve growth factor (NGF), brain derived neurotrophic factor (BDNF), substance P (SP), macrophage inflammatory protein-4 (MIP-4), matrix metalloproteinase-8 (MMP-8). ELISA kits for each target protein will be utilized to quantify the protein in the saliva and the unit will be according to the protocol provided in the kit. |
The saliva will be collected on Day 1
|
Saliva analysis
Time Frame: The saliva will be collected on Day 4
|
2 ml of saliva samples will be obtained from all the patients enrolled in the study at Day 0, Day 1, Day 4 and Day 7 time points in 15-ml Falcon tubes. The samples will be immediately frozen and stored at -80°C refrigerator until assayed. Multiplex immunoassay will be used to analyze target proteins: cortisol, testosterone, alpha amylase, interleukin 1β (IL-1β), prostaglandin E2 (PGE2), receptor activator of nuclear factor kappa-B ligand (RANKL), nerve growth factor (NGF), brain derived neurotrophic factor (BDNF), substance P (SP), macrophage inflammatory protein-4 (MIP-4), matrix metalloproteinase-8 (MMP-8). ELISA kits for each target protein will be utilized to quantify the protein in the saliva and the unit will be according to the protocol provided in the kit. |
The saliva will be collected on Day 4
|
Saliva analysis
Time Frame: The saliva will be collected on Day 7
|
2 ml of saliva samples will be obtained from all the patients enrolled in the study at Day 0, Day 1, Day 4 and Day 7 time points in 15-ml Falcon tubes. The samples will be immediately frozen and stored at -80°C refrigerator until assayed. Multiplex immunoassay will be used to analyze target proteins: cortisol, testosterone, alpha amylase, interleukin 1β (IL-1β), prostaglandin E2 (PGE2), receptor activator of nuclear factor kappa-B ligand (RANKL), nerve growth factor (NGF), brain derived neurotrophic factor (BDNF), substance P (SP), macrophage inflammatory protein-4 (MIP-4), matrix metalloproteinase-8 (MMP-8). ELISA kits for each target protein will be utilized to quantify the protein in the saliva and the unit will be according to the protocol provided in the kit. |
The saliva will be collected on Day 7
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Ngan P, Kess B, Wilson S. Perception of discomfort by patients undergoing orthodontic treatment. Am J Orthod Dentofacial Orthop. 1989 Jul;96(1):47-53. doi: 10.1016/0889-5406(89)90228-x.
- Baldini A, Nota A, Santariello C, Assi V, Ballanti F, Cozza P. Influence of activation protocol on perceived pain during rapid maxillary expansion. Angle Orthod. 2015 Nov;85(6):1015-20. doi: 10.2319/112114-833.1. Epub 2015 Mar 10.
- Long H, Wang Y, Jian F, Liao LN, Yang X, Lai WL. Current advances in orthodontic pain. Int J Oral Sci. 2016 Jun 30;8(2):67-75. doi: 10.1038/ijos.2016.24.
- Ren Y, Vissink A. Cytokines in crevicular fluid and orthodontic tooth movement. Eur J Oral Sci. 2008 Apr;116(2):89-97. doi: 10.1111/j.1600-0722.2007.00511.x.
- Topolski F, Moro A, Correr GM, Schimim SC. Optimal management of orthodontic pain. J Pain Res. 2018 Mar 16;11:589-598. doi: 10.2147/JPR.S127945. eCollection 2018.
- Monk AB, Harrison JE, Worthington HV, Teague A. Pharmacological interventions for pain relief during orthodontic treatment. Cochrane Database Syst Rev. 2017 Nov 28;11(11):CD003976. doi: 10.1002/14651858.CD003976.pub2.
- White DW, Julien KC, Jacob H, Campbell PM, Buschang PH. Discomfort associated with Invisalign and traditional brackets: A randomized, prospective trial. Angle Orthod. 2017 Nov;87(6):801-808. doi: 10.2319/091416-687.1. Epub 2017 Jul 28.
- Wiedel AP, Bondemark L. A randomized controlled trial of self-perceived pain, discomfort, and impairment of jaw function in children undergoing orthodontic treatment with fixed or removable appliances. Angle Orthod. 2016 Mar;86(2):324-30. doi: 10.2319/040215-219.1. Epub 2015 Jul 17.
- Johal A, Fleming PS, Al Jawad FA. A prospective longitudinal controlled assessment of pain experience and oral health-related quality of life in adolescents undergoing fixed appliance treatment. Orthod Craniofac Res. 2014 Aug;17(3):178-86. doi: 10.1111/ocr.12044. Epub 2014 Apr 7.
- Polat O, Karaman AI. Pain control during fixed orthodontic appliance therapy. Angle Orthod. 2005 Mar;75(2):214-9. doi: 10.1043/0003-3219(2005)0752.0.CO;2.
- Panda S, Verma V, Sachan A, Singh K. Perception of pain due to various orthodontic procedures. Quintessence Int. 2015 Jul-Aug;46(7):603-9. doi: 10.3290/j.qi.a33933.
- Mangnall LA, Dietrich T, Scholey JM. A randomized controlled trial to assess the pain associated with the debond of orthodontic fixed appliances. J Orthod. 2013 Sep;40(3):188-96. doi: 10.1179/1465313313Y.0000000045.
- Dray A. Inflammatory mediators of pain. Br J Anaesth. 1995 Aug;75(2):125-31. doi: 10.1093/bja/75.2.125.
- Zeng M, Kou X, Yang R, Liu D, Wang X, Song Y, Zhang J, Yan Y, Liu F, He D, Gan Y, Zhou Y. Orthodontic Force Induces Systemic Inflammatory Monocyte Responses. J Dent Res. 2015 Sep;94(9):1295-302. doi: 10.1177/0022034515592868. Epub 2015 Jun 30.
- Scott DA, Krauss J. Neutrophils in periodontal inflammation. Front Oral Biol. 2012;15:56-83. doi: 10.1159/000329672. Epub 2011 Nov 11.
- Yan Y, Liu F, Kou X, Liu D, Yang R, Wang X, Song Y, He D, Gan Y, Zhou Y. T Cells Are Required for Orthodontic Tooth Movement. J Dent Res. 2015 Oct;94(10):1463-70. doi: 10.1177/0022034515595003. Epub 2015 Jul 17.
- Fleming PS, Strydom H, Katsaros C, MacDonald L, Curatolo M, Fudalej P, Pandis N. Non-pharmacological interventions for alleviating pain during orthodontic treatment. Cochrane Database Syst Rev. 2016 Dec 23;12(12):CD010263. doi: 10.1002/14651858.CD010263.pub2.
- Wu S, Chen Y, Zhang J, Chen W, Shao S, Shen H, Zhu L, Ye P, Svensson P, Wang K. Effect of low-level laser therapy on tooth-related pain and somatosensory function evoked by orthodontic treatment. Int J Oral Sci. 2018 Jul 2;10(3):22. doi: 10.1038/s41368-018-0023-0.
- Al-Okla N, Bader D, Al-Mulla A, Ferguson D, Shaughnessy T. Effect of photobiomodulation on pain perception among orthodontic patients: a randomized clinical trial. J Clin Orthod. 2020 Feb;54(2):96-103. No abstract available.
- Farias RD, Closs LQ, Miguens SA Jr. Evaluation of the use of low-level laser therapy in pain control in orthodontic patients: A randomized split-mouth clinical trial. Angle Orthod. 2016 Mar;86(2):193-8. doi: 10.2319/122214-933.1. Epub 2015 Jul 1.
- Sfondrini MF, Vitale M, Pinheiro ALB, Gandini P, Sorrentino L, Iarussi UM, Scribante A. Photobiomodulation and Pain Reduction in Patients Requiring Orthodontic Band Application: Randomized Clinical Trial. Biomed Res Int. 2020 May 25;2020:7460938. doi: 10.1155/2020/7460938. eCollection 2020.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00112179
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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