drugset / Trial / NCT04512638

Best Treatment Choice for Osteonecrosis of the Jaw

NCT04512638

RandomizedParallel-groupOpen-labelTreatment

Summary

BETCON is a pragmatic randomized controlled open-label multi-center study in patients with newly diagnosed stage I-II MRONJ designed to answer the question whether minimally invasive management with LPRF membranes or primary surgical treatment is better than the standard of care of conservative therapy alone. The primary end-point is the time to mucosal healing. Secondary end-points consist of supporting measures of efficacy, patient reported symptoms, quality of life, well-being, and functioning.

Timeline

Start
2021-01-01
Primary completion
2025-10-01
Completion
2026-01-01

Drugs

EvaluationDrugModalityDoseRoute
Background Amoxicillin Other / unclassified 875 mg Oral
Background Amoxicillin Other / unclassified 1 g Oral
Background Chlorhexidine Small molecule 0.05 % Oral
Background Clindamycin Unknown 300 mg Oral