Predictive Score For Maxillary Osteonecrosis After Invasive Oral Surgery (PREV-ONM)

April 21, 2022 updated by: Centre Hospitalier Sud Francilien

Development Of A Predictive Score For Maxillary Osteochimionecrosis After Invasive Oral Surgery In Patients Treated Whith Biphosphonates Or Biotherapies: The PREV-ONM Study

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.

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aulnay-sous-Bois, France, 93600
        • Centre Hospitalier Intercommunal Robert Ballanger
      • Corbeil-Essonnes, France, 91106
        • Centre Hospitalier Sud Francilien
      • Créteil, France, 94010
        • Centre Hospitalier Universitaire Henri Mondor
      • Vannes, France, 56017
        • Centre Hospitalier Bretagne Atlantique
      • Villejuif, France, 94805
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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) and who has had an oral surgical procedure (single or multiple dental extraction, with or without alveolectomy, under local or general anesthesia)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
occurrence of osteonecrosis of the jaw
Time Frame: within 3 months after surgery
occurrence of osteonecrosis of the jaw
within 3 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of post-operative healing (bone and gingival) and comparison to each patient's UCONNS score.
Time Frame: 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)
within 3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Sud Francilien

Investigators

  • Principal Investigator: Emeline Noaillon, MD, Centre Hospitalier Sud Francilien

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2019

Primary Completion (Actual)

April 6, 2022

Study Completion (Actual)

April 6, 2022

Study Registration Dates

First Submitted

February 4, 2020

First Submitted That Met QC Criteria

February 5, 2020

First Posted (Actual)

February 6, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-A01495-52

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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