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.

The authors have declared no competing interest.

NCT05924204

https://clinicaltrials.gov/study/NCT05924204?term=NCT05924204&rank=1

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.

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 Católica del Uruguay (#221014b) on 14th October 2022.

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Yes

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Yes

Deidentified research data will be made publicly available when the study is completed and published.