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The objective of this study is to determine to effect of PBM Ortho, a photobiomodulation device, in adult patients undergoing clear aligners orthodontic treatment. We hypothesize that PBM Ortho will reduced the orthodontic associated pain in the clear aligner patients. This effect will be evaluated by recording the pain on visual analog scale given to the patients before the placement of clear aligners and collecting saliva.
Pain associated with orthodontic treatment is one of the main causes of treatment discontinuation and patient non-cooperation. Several treatment modalities have been studied to alleviate orthodontic pain which includes pharmacological, mechanical, and behavioral approach. One potential treatment is the application of photobiomodulation (PBM) therapy which is a form of light therapy. The objective of this study is to determine to effect of PBM therapy in adult patients undergoing clear aligners orthodontic treatment. This effect will be evaluated by recording the pain on visual analog scale given to the patients before the placement of clear aligners and collecting saliva. The patients will be provided with active PBM Ortho device and sham PBM device (placebo, which will look similar to the active device) to use them at home for one 8 minutes application for 7 days (4 minutes per arch, upper or lower). The pain scale sheets will also be given to the patients to fill them every day for 7 days. The inflammatory protein associated with pain present in the saliva will be collected on Day 1 (24 hours after clear aligner treatment start), Day 4 (fourth day of treatment), and Day 7 (after 1 week from the treatment start). On the last visit, the device and pain scale sheets will be collected from the patients. If successful, this device therapy will reduce the orthodontic associated pain and improve patients' compliance and cooperation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PBM Ortho Active device | Active Comparator | PBM Ortho Active group will be given an active device. |
|
| PBM Ortho Sham | Sham Comparator | PBM Ortho Sham device group will be given a non-active device that will not emits light. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PBM Ortho | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual analog scale | 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 | 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 | 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Saliva analysis | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sphinx Orthodontic | Edmonton | Alberta | T5K 2L2 | Canada | ||
| Orthodontic Graduate Clinic, Kaye Clinic, University of Alberta |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28753032 | Background | 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. | |
| 26185899 | Background | 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. |
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| ID | Term |
|---|---|
| D008310 | Malocclusion |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Day 3 |
| Visual analog scale | 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 | 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 | 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 | 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 |
| The saliva will be collected on Day 0 |
| Saliva analysis | 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 | 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 | 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 |
| Edmonton |
| Alberta |
| T6G 1Z1 |
| Canada |
| 24703180 | Background | 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. |
| 15825785 | Background | 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. |
| 27341389 | Background | 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. |
| 25918756 | Background | 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. |
| 25757063 | Background | 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. |
| 24009318 | Background | 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. |
| 7577246 | Background | Dray A. Inflammatory mediators of pain. Br J Anaesth. 1995 Aug;75(2):125-31. doi: 10.1093/bja/75.2.125. |
| 18353001 | Background | 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. |
| 26130260 | Background | 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. |
| 22142957 | Background | Scott DA, Krauss J. Neutrophils in periodontal inflammation. Front Oral Biol. 2012;15:56-83. doi: 10.1159/000329672. Epub 2011 Nov 11. |
| 26187644 | Background | 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. |
| 29588616 | Background | 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. |
| 29182798 | Background | 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. |
| 2750720 | Background | 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. |
| 28009052 | Background | 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. |
| 29967411 | Background | 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. |
| 32554911 | Background | 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. |
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| 32596367 | Background | 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. |