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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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The purpose of this study is to determine whether the oral alendronate treatment of post-menopausal osteoporosis could be a risk factor for jaw bone healing after dental extraction.
Alendronate is the main oral bisphosphonate used in the treatment and the prevention of the postmenopausal osteoporosis because of its high antiresorbant ability for bone tissue. Alendronate delayed bone healing after dental extraction on animals models, murine as canine. Anti-angiogenic and anti-osteoclastic characteristics are suggested to explain this phenomenon. There is no available data in human and it is now well known that bisphosphonates are involved in the occurrence of osteonecrosis of the jaws even if this major adverse effect seems to be very seldom with oral alendronate. Moreover, bisphosphonate showed toxicity for oral mucosal cells. The main aim of this study is to quantify the impact of oral alendronate weekly treatment on bone and mucosa healing after dental extraction in postmenopausal osteoporotic women. A secondary aim is to investigate a panel of 50 peptids potentially involved in bone and mucosal healing and to detect changes in their rates by salivary proteomic approach. The investigators hope so identify salivary biomarkers of bone and/or mucosa healing in these women.
Our hypothesis is that after dental extraction, bone healing could be delayed in postmenopausal osteoporotic women treated with oral weekly alendronate (BP+ group) versus matched osteoporotic women untreated with bisphosphonates (BP- group).
This is a prospective and multicentric (17 investigation centers dispatched in France) study including 140 osteoporotic postmenopausal women treated weekly with oral bisphosphonates (BP+ group) and 140 osteoporotic postmenopausal women untreated with bisphosphonates (BP- group). This is a clinical follow-up study (T0, T0 + 7, T0 + 30, T0 + 90 days), a radiological study (T0, T0 + 30, T0 + 90 days), and a salivary proteomic study (T0, T0 + 30, T0 + 90 days). This is a 4 years study starting in april 2012 (anticipated date).
The main investigated parameters are:
The investigators expect that this study will allow us to build a reference scale of bone and mucosa healing in osteoporotic postmenopausal women treated weekly by oral alendronate. This scale will be a helpful tool for dental physicians. The investigators hope also to identify salivary biomarkers variations to make a diagnosis and a prognosis tool of worse bone healing in these patients.
Perspectives of this study is to constitute a national network of deleterious effect on bone healing in such women patients and to up-date guidelines in this area.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women treated by bisphosphonate | Active Comparator | Postmenopausal osteoporotic women treated by alendronate 70 mg weekly per os |
|
| Women didn't treat by bisphosphonate | Sham Comparator | Postmenopausal osteoporotic women untreated by bisphosphonates |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dental extraction | Procedure | 3 dental radiographies realised immediately, then 30 days, then 90 days after dental extraction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Alveolar socket filled by new bone | Rate in % of the alveolar socket filled by new bone | 3 months after extraction |
| Measure | Description | Time Frame |
|---|---|---|
| Mucosal injury | Direct measure of mucosal injury wtih a mini-electronic caliper | 7 days after extraction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian ROUX, MD, PhD | Hôpital Cochin | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hotel-Dieu Hospital | Nantes | 44042 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32404281 | Result | Lesclous P, Cloitre A, Catros S, Devoize L, Louvet B, Chatel C, Foissac F, Roux C. Alendronate or Zoledronic acid do not impair wound healing after tooth extraction in postmenopausal women with osteoporosis. Bone. 2020 Aug;137:115412. doi: 10.1016/j.bone.2020.115412. Epub 2020 May 20. |
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| ID | Term |
|---|---|
| D014081 | Tooth Extraction |
| ID | Term |
|---|---|
| D019647 | Oral Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D003813 | Dentistry |
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