Effect of Photobiomodulation to Reduce Post-operative Pain After Endodontic Surgery
Effect of Photobiomodulation to Reduce Post-operative Pain After Endodontic Surgery: a Randomized Controlled Clinical Trial
University of Nove de Julho
34 participants
Jun 30, 2024
INTERVENTIONAL
Conditions
Summary
The objective of this study will be to evaluate if photobiomodulation (FBM) 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) a FBM 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 analog 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 2 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 extra-oral maxilla will also be evaluated. In addition, a digital thermometer. These parameters will be evaluated 24 hours and 7 days after the intervention. The X-rays will be taken in the 1st and 3rd month respectively.
Eligibility
Inclusion Criteria5
- :• Patients with periapical lesions who have already undergone endodontic treatment (lesions smaller than 10mm in their greatest diameter - Metin et al., 2018, single and chronic lesions)
- Patients with not comorbidities,
- Age from 18 to 70 years,
- Both genders,
- Healthy permanent teeth with good hygiene.
Exclusion Criteria5
- Who are taking drugs that affect bone metabolism and the inflammatory process (for example: corticosteroids, bisphosphonates),
- Smokers, pregnant or lactating women,
- Who used anti-inflammatory drugs in the last 3 months before surgery.
- Who for any reason interrupted the evolution of the treatment for not attending joint appointments.
- Patients who do not follow the guidelines or have an injury in the acute phase (pain, edema, exudate)
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Interventions
All participants will undergo the same conventional surgical procedure. Patients will receive the FBM simulation and will be treated identically to the G2 group.
The person responsible for applying the FBM will simulate the radiation by placing the devices in the same places described for the FBM group, however, the equipment will remain turned off.
. Patients will receive FBM and will be treated identically to the G2 group. The irradiated region will be on the lesion at 4 equidistant points on the vertex of a flat square 1 cm away.
Placebo ibuprofen will be manipulated by pharmacy (Matias Gonzalez)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05935306