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Best Treatment Choice for Osteonecrosis of the Jaw

NCT04512638 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2023-05-23

No results posted yet for this study

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.

Conditions

  • Medication Related Osteonecrosis of the Jaw

Interventions

DRUG

Antibiotics

Antibiotic treatment is the same in all groups. Monotherapy for 4 weeks with: No penicillin contra-indication * Amoxicillin-clavulanate 875mg tid PO Penicillin contra-indication or intolerance * Clindamycin 300mg tid PO After 4 weeks patients will be switched to consolidation antibiotics: No penicillin contra-indication * Amoxicillin 1g bid PO Penicillin contra-indication or intolerance * Clindamycin 300mg tid PO Antibiotic treatment can be discontinued after 4 weeks when the MRONJ lesions has healed.

DRUG

Chlorhexidine mouthwash

Patients in all treatment groups will be prescribed aqueous chlorhexidine 0.12% tid rinse for 2 weeks, with subsequent switch to 0.05% for the duration of the study or until healing of the MRONJ lesion has occurred.

PROCEDURE

Minimally invasive surgery with LPRF

Minimally-invasive surgical treatment, including sequestrectomy, debridement of soft tissue, and application of LPRF membranes before tension-free wound closure is obtained. Marginal resection of all necrotic bone is not part of this treatment strategy.

PROCEDURE

Surgical resection

Primary surgical management consisting of the removal of the necrotic bone without excessive resection of healthy bone. Buccal mucoperiosteal flaps will be used to achieve a tension-free mucosal coverage.

Sponsors & Collaborators

  • Kom Op Tegen Kanker

    collaborator OTHER

  • Tim Van den Wyngaert

    lead OTHER

Principal Investigators

  • Tim Van den Wyngaert, MD, PhD · University Hospital, Antwerp

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04512638 on ClinicalTrials.gov