Actively Recruiting
Led by University of Nove de Julho · Updated on 2025-05-07
34
Participants Needed
1
Research Sites
13 weeks
Total Duration
This research aims to evaluate whether photobiomodulation (FBM) can reduce postoperative pain in patients undergoing endodontic surgery on upper jaw teeth. The study is a randomized, controlled, and double-blind clinical trial involving 34 adult participants aged 18 to 70 years, all diagnosed with chronic periapical lesions smaller than 10mm and without comorbidities. The trial assesses pain levels and healing outcomes following the surgical procedure. Participants will be randomly assigned to one of two groups: an experimental group receiving photobiomodulation treatment with specific parameters (808nm wavelength, 100 mW power, 4J/cm2 energy density at five points on the vestibular area) immediately after surgery and again at 24 hours, and a control group receiving a simulated photobiomodulation procedure with placebo ibuprofen. Both groups will undergo the same standard surgical procedures considered gold standard. The study uses triple blinding so neither patients, evaluators, nor treatment administrators know group assignments. During the study, participants will be monitored for postoperative pain using a visual analog scale at baseline, 24 hours, and 7 days after surgery. Secondary measures include the amount of analgesic medication taken, swelling (edema), bruising (ecchymosis), soft tissue healing, and local and systemic temperature measured at the same time points. Radiographic images will be taken digitally at 1 and 3 months to evaluate bone repair and lesion healing. These assessments will provide comprehensive data on pain relief and tissue recovery over time.
CONDITIONS
Effect of Photobiomodulation to Reduce Post-operative Pain After Endodontic Surgery
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 days
Participants undergo endodontic surgery followed by photobiomodulation or its simulation immediately after surgery and 24 hours later to reduce postoperative pain.
2 visits (immediate post-surgery and 24 hours after surgery)
Duration - 7 days
Participants are monitored for pain, edema, ecchymosis, soft tissue healing, and local and systemic temperature at baseline, 24 hours, and 7 days after surgery.
3 visits (baseline, 24 hours, and 7 days after surgery)
Duration - 3 months
Radiographic images are taken to evaluate bone consolidation and lesion repair at 1 and 3 months after surgery.
2 visits (1 month and 3 months post-surgery)
Total: 1 location
1
Universidade Catolica do Uruguay
Montevideo, Uruguay
Actively Recruiting
R
Rolf Wilhem C Cirisola
A
Anna CR Horliana
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Rolf Wilhem Consolandich Cirisola, Luis Eduardo Pascuali Moya, María Victoria García Olazabal...
https://pubmed.ncbi.nlm.nih.gov/41218940