Predictive Score for Maxillary Osteonecrosis After Invasive Oral Surgery

Terminated

• Conditions: Osteonecrosis Due to Drugs, Jaw

• Registration Number: NCT04257721
• Lead Sponsor: Centre Hospitalier Sud Francilien

Brief 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.

Detailed Description

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 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®)

The study protocol is based on the post-operative clinical and radiographic follow-up of patients. 3 consultations are scheduled:

* 1 week after surgery

* 1 month after surgery

* 3 months after surgery

The following information should be noted at each follow-up consultation:

* Appearance of gingival and mucosal tissues : normal or inflammatory physiological state

* Description of possible bone exposure: size, colour, spontaneous or induced bleeding

* Description and assessment of local pain

* Description of a local infection

* Results of a bacteriological sample in case of suppuration

The patient's participation in the study ends:

* at the end of one of the consultations at 1 week and 1 month as soon as osteochimionecrosis of the jaws is diagnosed by the investigating physician

* at the end of the consultation at 3 months otherwise

* in the event of the patient's death during the study

* in the event of the patient's renouncement to participate in the study The patient's participation period is therefore a maximum of 3 months.

Study Timeline

• Study Start: 2019-10-10
• Study First Submitted: 2020-02-04
• Study First Submitted QC: 2020-02-05
• Study First Posted: 2020-02-06
• Primary Completion: 2022-04-06
• Study Completion: 2022-04-06
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 45

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
occurrence of osteonecrosis of the jaw	within 3 months after surgery	occurrence of osteonecrosis of the jaw

Secondary Outcome Measures

Name	Time	Method
Frequency of post-operative healing (bone and gingival) and comparison to each patient's UCONNS score.	within 3 months after surgery	Frequency of post-operative healing (bone and gingival) and comparison to each patient's UCONNS score.; The UCONNS score was proposed in 2011. Its objective is to be able to predict the occurrence of osteochimionecrosis in conjunction with biphosphonate treatment before a dental invasive procedure (dental avulsions, implant placement, etc.). It takes into account several types of variables: * The patient's general condition and comorbidities (HIV, osteoporosis, rheumatoid arthritis, diabetes, presence or not of a soft tissue tumour, presence or not of a breast or prostate tumour, multiple myeloma, ...); * The nature, dose, and duration of use of the biphosphonate received; * Oral hygiene; * presence of suppuration, presence of osteomyelitis; * The dental surgery received (endodontic treatment, periodontal treatment, surgery muco-gingival, tooth extraction, apical surgery, bone resection)

Trial Locations

Locations (5)

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Centre Hospitalier Bretagne Atlantique; 🇫🇷 Vannes, France

Centre Hospitalier Intercommunal Robert Ballanger; 🇫🇷 Aulnay-sous-Bois, France

Centre Hospitalier Sud Francilien; 🇫🇷 Corbeil-Essonnes, France

Centre Hospitalier Universitaire Henri Mondor; 🇫🇷 Créteil, France