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rate of inclusions too low
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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.
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):
The study protocol is based on the post-operative clinical and radiographic follow-up of patients. 3 consultations are scheduled:
The following information should be noted at each follow-up consultation:
The patient's participation in the study ends:
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| Measure | Description | Time Frame |
|---|---|---|
| occurrence of osteonecrosis of the jaw | occurrence of osteonecrosis of the jaw | within 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of post-operative healing (bone and gingival) and comparison to each patient's UCONNS score. | 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:
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Inclusion Criteria:
Exclusion Criteria:
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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)
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| Name | Affiliation | Role |
|---|---|---|
| Emeline Noaillon, MD | Centre Hospitalier Sud Francilien | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Intercommunal Robert Ballanger | Aulnay-sous-Bois | 93600 | France | |||
| Centre Hospitalier Sud Francilien |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12966493 | Result | Marx RE. Pamidronate (Aredia) and zoledronate (Zometa) induced avascular necrosis of the jaws: a growing epidemic. J Oral Maxillofac Surg. 2003 Sep;61(9):1115-7. doi: 10.1016/s0278-2391(03)00720-1. No abstract available. | |
| 17307580 | Result | Advisory Task Force on Bisphosphonate-Related Ostenonecrosis of the Jaws, American Association of Oral and Maxillofacial Surgeons. American Association of Oral and Maxillofacial Surgeons position paper on bisphosphonate-related osteonecrosis of the jaws. J Oral Maxillofac Surg. 2007 Mar;65(3):369-76. doi: 10.1016/j.joms.2006.11.003. No abstract available. |
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| within 3 months after surgery |
| Corbeil-Essonnes |
| 91106 |
| France |
| Centre Hospitalier Universitaire Henri Mondor | Créteil | 94010 | France |
| Centre Hospitalier Bretagne Atlantique | Vannes | 56017 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| 25234529 | Result | Ruggiero SL, Dodson TB, Fantasia J, Goodday R, Aghaloo T, Mehrotra B, O'Ryan F; American Association of Oral and Maxillofacial Surgeons. American Association of Oral and Maxillofacial Surgeons position paper on medication-related osteonecrosis of the jaw--2014 update. J Oral Maxillofac Surg. 2014 Oct;72(10):1938-56. doi: 10.1016/j.joms.2014.04.031. Epub 2014 May 5. |
| 23605142 | Result | Qi WX, Tang LN, He AN, Yao Y, Shen Z. Risk of osteonecrosis of the jaw in cancer patients receiving denosumab: a meta-analysis of seven randomized controlled trials. Int J Clin Oncol. 2014 Apr;19(2):403-10. doi: 10.1007/s10147-013-0561-6. Epub 2013 Apr 20. |
| 19371816 | Result | Allen MR, Burr DB. The pathogenesis of bisphosphonate-related osteonecrosis of the jaw: so many hypotheses, so few data. J Oral Maxillofac Surg. 2009 May;67(5 Suppl):61-70. doi: 10.1016/j.joms.2009.01.007. |
| 26362756 | Result | Gaudin E, Seidel L, Bacevic M, Rompen E, Lambert F. Occurrence and risk indicators of medication-related osteonecrosis of the jaw after dental extraction: a systematic review and meta-analysis. J Clin Periodontol. 2015 Oct;42(10):922-32. doi: 10.1111/jcpe.12455. Epub 2015 Nov 3. |
| 22898302 | Result | Peddi P, Lopez-Olivo MA, Pratt GF, Suarez-Almazor ME. Denosumab in patients with cancer and skeletal metastases: a systematic review and meta-analysis. Cancer Treat Rev. 2013 Feb;39(1):97-104. doi: 10.1016/j.ctrv.2012.07.002. Epub 2012 Aug 13. |
| 21291478 | Result | Landesberg R, Woo V, Cremers S, Cozin M, Marolt D, Vunjak-Novakovic G, Kousteni S, Raghavan S. Potential pathophysiological mechanisms in osteonecrosis of the jaw. Ann N Y Acad Sci. 2011 Feb;1218:62-79. doi: 10.1111/j.1749-6632.2010.05835.x. |
| 26321065 | Result | Reich W, Bilkenroth U, Schubert J, Wickenhauser C, Eckert AW. Surgical treatment of bisphosphonate-associated osteonecrosis: Prognostic score and long-term results. J Craniomaxillofac Surg. 2015 Nov;43(9):1809-22. doi: 10.1016/j.jcms.2015.07.035. Epub 2015 Aug 6. |