PBM Healing International Limited
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.
Malocclusion
Orthodontic Treatment
PBM Ortho
Not Applicable
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.
Study Type : | Interventional |
Estimated Enrollment : | 50 participants |
Masking: | Quadruple |
Primary Purpose: | Treatment |
Official Title: | Impact of Photobiomodulation on Pain During Orthodontic Treatment |
Actual Study Start Date : | April 17, 2023 |
Estimated Primary Completion Date : | June 30, 2024 |
Estimated Study Completion Date : | June 30, 2024 |
Arm | Intervention/treatment |
---|---|
Active Comparator: PBM Ortho Active device PBM Ortho Active group will be given an active device. |
Device: PBM Ortho |
Sham Comparator: PBM Ortho Sham PBM Ortho Sham device group will be given a non-active device that will not emits light. |
Device: PBM Ortho |
Ages Eligible for Study: | 20 Years to 65 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Sphinx Orthodontic
Edmonton, Alberta, Canada, T5K 2L2
Recruiting
Orthodontic Graduate Clinic, Kaye Clinic, University of Alberta
Edmonton, Alberta, Canada, T6G 1Z1