Prospective Randomized Clinical Study: Role of Platelet Rich Fibrin (PRF) in the Tooth Extraction Site in the Prevention of Jaw Osteonecrosis on Patients Under Bisphosphonates Therapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Number of jaw osteonecrosis after tooth extraction
研究概览
简要总结
This prospective study will include patients taking or having taken bisphosphonates and needing dental extractions.
The aim of this study is to validate the contribution of PRF (Platelet Rich Fibrin) in tooth extraction sites.
In the test group (PRF) and in the control group (no PRF), we use the same atraumatic extraction protocol associated with the same antibiotic procedure.
详细描述
Dental extractions are the main cause of jaw osteonecrosis in patients taking oral or iv bisphosphonates.
This prospective randomized study will include a cohort of 100 patients treated with bisphosphonates (for benign or malignant conditions) and requiring dental extractions (non-retainable teeth for infectious, traumatic or parodontal reasons). 50 patients will benefit of PRF placement in the tooth extraction site (group 1) while 50 patients do not (group 2).
The rest of the procedure will be the same in the 2 arms. In the literature, studies suggest a benefit from a long term antibiotherapy before and after tooth extraction. Extraction procedure should be the least traumatic as possible.
The main objective of our study is to assess, after tooth extraction, the contribution of PRF in the prevention of jaw osteonecrosis induced by bisphosphonates.
A follow-up period of one year after extraction is indicated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients taking bisphosphonates whatever the indication, the type, the administration and the duration of treatment (we include patients taking or having taken bisphosphonates, even several years ago)
- •And who need tooth extraction (not recoverable in conservative dentistry and symptomatic tooth: dental and periodontal infections, symptomatic traumatic tooth fracture).
排除标准
- •pregnant women
- •younger than 50 years old
- •jaw's radiotherapy
- •history of jaw osteonecrosis
- •jaw metastasis from an other cancer
研究组 & 干预措施
tooth extraction and insertion of PRF
Experimental: Atraumatic tooth extraction with antibiotics( amoxicillin clavulanate combination) .Insertion of PRF membrane in tooth-extraction site.
干预措施: tooth extraction with antibiotics (amoxicillin- clavulanate, clindamycine) (Drug)
tooth extraction and insertion of PRF
Experimental: Atraumatic tooth extraction with antibiotics( amoxicillin clavulanate combination) .Insertion of PRF membrane in tooth-extraction site.
干预措施: atraumatic extraction (Procedure)
No PRF
Atraumatic extraction with antibiotic without PRF insertion
干预措施: tooth extraction with antibiotics (amoxicillin- clavulanate, clindamycine) (Drug)
No PRF
Atraumatic extraction with antibiotic without PRF insertion
干预措施: atraumatic extraction (Procedure)
结局指标
主要结局
Number of jaw osteonecrosis after tooth extraction
时间窗: 1year
7 symptoms \> 6 weeks for the diagnosis of osteonecrosis: * bone exposure * bone spicule * mucosal inflammation * pain * paresthésias * suppuration * jaw fracture * number of jaw osteonecrosis after tooth extraction in the oral bisphosphonates group in comparison with the IV bisphosphonates group
次要结局
未报告次要终点