UnknownPhase 4

Best Treatment Choice for Osteonecrosis of the Jaw

Belgium125 participantsStarted 2021-01-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria: * \>18 years of age * Provision of signed informed consent * A history of at least one administration of, or an ongoing treatment with, a bone modifying agent in dose registered for the prevention of skeletal related events in bone metastatic disease or multiple myeloma * Diagnosis of stage I-II MRONJ according to AAOMS 2014 criteria not more than 8 weeks prior to the date of screening Exclusion criteria: * Any prior treatment for MRONJ other than local antiseptic rinses, systemic antibiotics, or analgesics * Prior radiotherapy to the head and neck region * Medical contraindication to receive any of the possible study treatments * Stage III MRONJ characterized by very extensive bone necrosis, pathological fracture, or fistulas to the skin or sinuses * Multiple MRONJ lesions that cannot be closed in a single surgical procedure

What they're measuring

Time to confirmed mucosal healing

Timeframe: 12 months

Trial details

NCT IDNCT04512638

SponsorTim Van den Wyngaert

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-01

Contact for this trial

Tim Van den Wyngaert, MD, PhD

003238213568 tim.van.den.wyngaert@uza.be