Contribution of Platelet Rich Fibrin (PRF) After Tooth Avulsion in the Prevention of Healing Delay and of Jawbone Osteochemonecrosis Induced by Bisphosphonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 10
- 主要终点
- The appearance of osteochemonecrosis during the follow-up period
研究概览
简要总结
The main objective of our study is to assess, after tooth extraction, the efficacity of PRF in the prevention of healing delay and of jawbone osteochemonecrosis induced by bisphosphonates
详细描述
Scientific Context Bisphosphonates (BP) work by slowing down bone remodelling. They are used in the management of different types of cancers and for the treatment of osteoporosis. Recent studies warned that this drug could produce adverse effects on jawbones .In December 2007, the AFSSAPS (French agency for the Sanitary Security of Health Products) alerted the health professionals about the risks of spontaneous or induced osteonecrosis following invasive odontological procedures on patients receiving BP. Prevalence of these osteonecrosis varies from 6% to 10% after surgical intervention. A healing delay estimated between 20 to 25% of cases frequently precedes the occurrence of osteochemonecrosis.
On the whole , the total rate of all complications amounts to 30%. We are extremely limited in terms of prevention or treatment of an OCN patient. We intend to study a biological autologous sediment obtained from a blood sample for its capacity to avoid these complications supervening. The collection of a coagulum called Platelet Rich Fibrin or PRF susceptible to provide the essential ingredients for the mucous membrane and the bone healing is obtained by centrifugation. This biomaterial rich in autologous fibrin is a concentrate of leukocytes, platelets and a number of factors favouring cicatrisation and immune response. Clinical applications are already well documented in orthopaedic, thoracic and cardiac surgeries and, also in dermatology. The use of PRF in dental surgery is more recent. Literature on this topic is very limited but these new techniques give rise to high hopes. Since February 2007,thanks to the classification as a medical treatment by the AFSSAPS, the PRF technique has been authorized.
Objectives To appraise after dental avulsion the PRF efficiency in preventing delay of cicatrisation and jawbone osteochemonecrosis induced by BP.
This efficiency will be assessed by a retroalveolar X-ray performed at each visit. The main criteria for evaluation is the discovery of cicatrisation delay at week 8 and/or osteochemonecrosis during the follow up.
Material and methods
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient major(male or female)
- •Documented indication at the initial visit at day 0 (JO) for a maximum extraction of 3 teeth.
- •Treatment with nitrogenous or non-nitrogenous BP by intravenous injection or oral administration whichever the reason for this drug prescription:
- •on going BP treatment
- •patient having received a previous treatment with bisphosphonates (irrespective of the duration and withdrawal date of this treatment)
- •Patient having received the specific information letter regarding the study and having signed the clarified consent form.
排除标准
- •Patient having a maxillary or mandibulary OCN at Day 0(JO)
- •Positive HIV serology at Day 0(for patients belonging to the PRF group)
- •Previous history of maxillo-cervico-facial radiotherapy
- •Patients with estimated survival expectancy shorter than one year
- •Lack of social security cover
- •Inability of the patient to respect the study follow-up
- •Patient having reached his/her majority and under tutelage,trusteeship or protection of the court
- •Patient whose diagnosis could not be revealed to him/her (especially when the patient or their family expressed this wish).
结局指标
主要结局
The appearance of osteochemonecrosis during the follow-up period
时间窗: 1 year
Delay in cicatrisation at week 8
时间窗: 8 weeks
次要结局
- The characteristics of the received BP treatment: starting date of ongoing treatment, accumulated dose, type of BP, administration route(1 year)
- The precise location of the extraction site according to the tooth classification number(1 year)