Effect of Photobiomodulation to Control Pain after Placement of Elastomeric Spacers: a Randomized Controlled Study Protocol

Recent studies have shown that photobiomodulation (FBM) can modulate pain after the placement of elastomeric separators, however, to date, there is no ideal protocol for its application. Therefore, the objective of this study will be to evaluate the effect of photobiomodulation on pain control 24 hours after the placement of elastomeric separators using the visual analog scale (VAS). Twenty-five participants between 13 and 30 years old with the need for the placement of orthodontic bands in the lower first molars bilaterally will be included, which establishes a sample of fifty molars (right and left). Elastomeric separators will be placed on the mesial and distal surfaces of the right and left molars. The study groups will be G1 (experimental) - elastomeric separators + FBM (diode laser, 808nm, 100mw power, with 4 J, 3 points per vestibular and 3 points per palatal, single session) and G2-(control)-elastomeric separators + FBM simulation. Treatment will be randomized to the right molar and the opposite treatment will be applied to the left side. The patient and the evaluator will be blinded to the intervention performed. The primary outcome variable will be spontaneous pain assessed 24 hours after the placement of elastomeric separators measured with the VAS scale. Secondary outcome variables will be pain during mastication (measured with the VAS scale) at 72h after the placement, count of the number of analgesics (paracetamol), and local temperature (measured with a digital thermometer). To assess the impact of oral health on quality of life. of the participant, the OHIP-14 questionnaire will be applied. All the outcomes will be evaluated at baseline, 24 and 72 hours after the placement of elastomeric separators. If the data are normal, they will be submitted to the ANOVA – one-way test. Data will be presented as means ± SD and the p-value will be set to < 0.05. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT05924204 ### Clinical Protocols ### Funding Statement The funders did not and will not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study received approval from the Committee for Ethics in Research (CEP) at the Universidad Cat#x00F3;lica del Uruguay (#221014b) on 14th October 2022. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Deidentified research data will be made publicly available when the study is completed and published.