TerminatedNot Applicable

Predictive Score For Maxillary Osteonecrosis After Invasive Oral Surgery

Stopped: rate of inclusions too low

France45 participantsStarted 2019-10-10

Plain-language summary

Non-interventional prospective multicentre cohort study to determine a predictive score for the occurrence of osteochimionecrosis of the jaws after invasive oral surgery in patients who have received biphosphonates or antangiogenic drugs as part of chemotherapy with malignant bone disease (multiple myeloma or bone metastasis of a solid tumour). Data are collected during the usual follow-up of patients during the first 3 months following surgery.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * patients who have received at least one of the following molecules as part of chemotherapy with malignant bone disease (multiple myeloma or bone metastasis of a solid tumour): * Biphosphonates: ZOLEDRONATE (ZOMETA®), PAMIDRONATE (AREDIA®, OSTEPAM®) * Anti-angiogenic: DENOSUMAB (XGEVA®), BEVACIZUMAB (AVASTIN®), RITUXIMAB (MABTHERA®, RIXATHON®, TRUXIMA®), SUNITINIB (SUTENT®), PAZOPANIB (VOTRIENT®), AXITINIB (INLYTA®), CARBOZANTINIB (CABOMETYX®, COMETRIQ®), SORAFENIB (NEXAVAR®) * Patient who has had an oral surgical procedure (single or multiple dental extraction, with or without alveolectomy, under local or general anesthesia) Exclusion Criteria: * History of oral and/or cervico-facial radiotherapy * Patient treated successively with biphosphonates and then with anti-angiogenic drugs. * Patient under guardianship, curatorship, or imprisonment * Patient who has notified his refusal to participate in the research

What they're measuring

occurrence of osteonecrosis of the jaw

Timeframe: within 3 months after surgery

Trial details

NCT IDNCT04257721

SponsorCentre Hospitalier Sud Francilien

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-04-06