Photobiomodulation (PBM) has shown favorable results in the postoperative period of endodontic surgery, however, up to now, the level of evidence in this procedure is low. The objective of this study will be to evaluate if photobiomodulation (PBM) can reduce postoperative pain in patients who will undergo endodontic surgery. For this randomized, controlled, and double-blind clinical study, 34 patients without comorbidities who need endodontic surgery in the upper jaw (15 to 25 teeth) will be recruited. They will be randomly divided into an experimental group (n = 17) photobiomodulation (808nm, 100 mW, and 4J/cm2 with 5 points per vestibular). Applications will be made in the immediate postoperative period and 24 hours after surgery. Control group (n = 17) PBM simulation will be performed in the same way as in the experimental group. In this group, the required analgesia will be administered within the standard with ibuprofen. Both groups will perform the necessary conventional procedures considered the gold standard in the literature. Both the patient and the evaluator will be blinded to the intervention performed. The primary outcome variable of the study will be postoperative pain, which will be assessed using the visual analogue scale at all postoperative control visits (baseline, 24 hours and 7 days). As for the secondary outcome variables, the amount of systemic medication received according to the patient’s need (will be provided by the investigator). Radiographic images will be obtained after 1 and 3 months for evaluation of the repair (dimensions of the lesion, radiopacity). These radiographs will be taken digitally with the positioners implemented. Edema, ecchymosis, and evaluation of soft tissues in the anterior portion of the intra and extraoral maxilla will also be evaluated. In addition, the temperature with a digital thermometer. These parameters will be evaluated 24 hours and 7 days after the intervention. The intervention and the X-rays will be taken in the 1st and 3rd month respectively. Once all the data have been collected, their normality will be tested, and the one-way ANOVA test and the complementary Tukey test will be carried out. Data will be presented as mean ± standard deviation (SD) and the accepted p-value will be <0.05.

The authors have declared no competing interest.

NCT05935306 (version: September 2023)N/A

https://clinicaltrials.gov/search?cond=NCT05935306

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I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

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Ethics approval Statement - The project received approval from the Research Ethics Committee of Universidad Católica del Uruguay (UCU), process: 220914

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data availability Statement-all data will be available for the readers.

funding Statement – One author receives a grant from the National Council for Scientific and Technological Development process (CNPq:3146682020-9).

conflict of interest disclosure All authors disclose any financial and personal relationships with other people or organizations that could inappropriately influence (bias) this study.

ethics approval Statement - The project received approval from the Research Ethics Committee of Universidad Católica del Uruguay (UCU), process: 220914

patient consent Statement – All the participants included signed an Informed consent.

clinical trial registration NCT05935306 (version: September 2023)

protocol modifications All the modifications in the protocol will be communicated to relevant parties.

Dissemination policy: We will share trial results with participants, healthcare professionals, the public, and relevant groups.

All relevant data from this study will be made available upon study completion