Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
Healthy Volunteers
NCT05935306

Effect of Photobiomodulation to Reduce Post-operative Pain After Endodontic Surgery

Led by University of Nove de Julho · Updated on 2025-05-07

34

Participants Needed

1

Research Sites

74 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Effect of Photobiomodulation to Reduce Post-operative Pain After Endodontic Surgery

Who Can Participate

Age: 18Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with periapical lesions smaller than 10mm who have already undergone endodontic treatment
  • Patients without comorbidities
  • Age from 18 to 70 years
  • Both genders
  • Healthy permanent teeth with good hygiene
Not Eligible

You will not qualify if you...

  • Taking drugs affecting bone metabolism or inflammation (e.g., corticosteroids, bisphosphonates)
  • Smokers, pregnant or lactating women
  • Used anti-inflammatory drugs in the last 3 months before surgery
  • Interrupted treatment by missing joint appointments
  • Not following guidelines or having acute-phase injury (pain, swelling, exudate)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Universidade Catolica do Uruguay

Montevideo, Uruguay

Actively Recruiting

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Research Team

R

Rolf Wilhem C Cirisola

CONTACT

A

Anna CR Horliana

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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