The Role of Surgical Flap Design on the Healing of Intraosseous Defects Treated by Means Regenerative Therapy. Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Clinical attachment level gain ( CAL gain)
研究概览
简要总结
The aim of the present study was to evaluate the impact of surgical flap design on the healing of intrabony defects treated by means periodontal regeneration. Forty patients were enrolled and allocated random in two groups. Patients of test group received a minimally invasive surgical flap , while patients of control group received a conventional access flap. In both group the intrabony were treated by means the same periodontal regeneration procedure (i.e application of enamel matrix derivative). Periodontal parameters were recoded at baseline and after 12-months observation time.
详细描述
This study was designed as multicenter randomized control clinical trial. The present trial was conduced according to CONSORT statement for improving the quality of reports of parallel-group randomized trials .
The intra-bony defects of subjects allocated in test group were treated with a combination of minimally invasive surgical technique (MIST) and enamel matrix derivative(EMD), while the intra-bony defects of control group were treated using a combination of conventional open flap debridement with papilla preservation (COFD+PP) and EMD.
Primary outcome
The primary outcome was based on Clinical attachment level gain( CAL gain)
Null hypothesis
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patients suffering from chronic periodontitis;
- •Male and female ;
- •Age 18 years old;
- •Presence of intra-bony defects (contained and non-contained defects) in either the maxilla or the mandible with a PD ≥ 6 mm.
- •II and III wall Intra-bony defects with an intra-bony component range from 3 mm to 6 mm for both groups;
- •Intra-bony defect located only at one aspect ( mesial or distal)
排除标准
- •• Patients with systemic disease;
- •Prolonged antibiotic treatment or anti-inflammatory treatment within 4 weeks prior to surgery;
- •Pregnant or lactating;
- •Tobacco smokers;
- •Patients with FMPS and FMBS 25 % after completion of non surgical periodontal therapy (recorded at six sites per tooth);
- •Furcations;
- •Third molars
- •Teeth with circumferencial defects
- •I-wall intra-bony defects
结局指标
主要结局
Clinical attachment level gain ( CAL gain)
时间窗: At 12 months
Vertical measure from the cement enamel junction to the bottom of the defect.
次要结局
未报告次要终点
研究者
Vincenzo Iorio-Siciliano
DDS,PhD
Iorio Research and Dental Practice