Modified Minimally Invasive Surgical Technique in Human Intrabony Defects With or Without Regenerative Materials 10-year Follow-up of a Randomized Clinical Trial: Tooth Retention, Periodontitis Recurrence and Costs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Clinical attachment level changes
研究概览
简要总结
Evaluate the 10-year stability clinical, radiographic outcomes obtained with the application of the modified minimally invasive surgery to deep pockets associated with intrabony defects.
详细描述
This 10-year follow-up of a randomized controlled clinical trial (Cortellini & Tonetti 2011) compares three treatment modalities in deep intrabony defects: i) a control group was treated with modified minimally invasive surgical technique alone (M-MIST, N=15); ii) a second group was treated with M-MIST combined with enamel matrix derivative (M-MIST EMD, N=15, Straumann, Switzerland); iii) a third group was treated with M-MIST+EMD plus Bone Mineral Derived Xenograph (M-MIST+EMD+BMDX, N=15, Geistlich, Switzerland) . The design of the original trial has been reported along with the one-year results and the details of randomization and allocation concealment (Cortellini & Tonetti 2011). Clinical outcomes of the three groups were longitudinally followed for 10 years. The 10-year follow-up was approved by the local ethical committee for clinical research of the Health Service of Tuscany (University Hospital of Firenze protocol ATRO2019, registration n° 15106_oss). All patients gave informed consent to participate into the clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Allocation concealment of surgeon until completion of common part of surgical intervention. Examiner (clinical and radiographic ) and other carers blind to allocation
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
- •Subjects with periodontitis
- •Presence of one intrabony defect not extending into furcation
- •Good general health
- •Adequate plaque control
排除标准
- •Furcation involvement in the experimental tooth
- •Inadequate control of periodontitis
结局指标
主要结局
Clinical attachment level changes
时间窗: 10 years
Periodontal probing to the nearest millimetre
次要结局
- Probing pocket depts(10 years)
- Tooth survival(10 years)
- Complication-free survival(10 years)
- Cost of recurrence(10 years)
- Radiographic bone level(10 years)
