Anti-infectious Therapy of Chronic Periodontitis Using One Stage Full Mouth Disinfection With Subgingival Airpolishing - a Comparison of Different Clinical Strategies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 228
- 试验地点
- 10
- 主要终点
- Change of clinical attachment level
研究概览
简要总结
It is the aim of the study to evaluate the efficiency of "One stage full mouth disinfection" according to the original protocol (Quirynen et al. 1995) in comparison to other approaches considering different scaling strategies and different disinfection concepts. Therefore, a multicenter randomized control treatment will be performed. In total, 204 patients with chronic periodontitis shall be allocated to the following treatment concepts. Group A: quadrant scaling with weekly intervals (Q-SRP; N = 51); Group B: full mouth scaling (FMS; N = 51); Group C: full mouth disinfection (FMD; N = 51); Group D: full mouth disinfection with subgingival glycine air polishing using erythritol powder (FMDP; N = 51). Evaluation of periodontopathic parameters and periodontal pathogens at baseline, 3 months and 6 months shall give evidence about the benefits of concept and the single components of FMD.
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 (Investigator)
盲法说明
The examiner performing the measurement of all clinical periodontal parameters is not aware of the type of treatment provided to the patient.
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
- •patients with generalized moderate to severe chronic periodontitis
- •presence of at least 18 teeth
- •with at least 2 multi-rooted and / or 2 single-rooted teeth in the first quadrant with at least 6 sites with periodontal probing depth of ≥ 6 mm
- •radiographic bone loss of at least 25% of the root length
排除标准
- •subgingival scaling and root planing within the last 12 months
- •antimicrobial rinsing or intake of systemic antibiotics within the last 4 months
- •systemic diseases with known interactions to periodontal disease or known need for antibiotic prophylaxis
- •known intolerance / allergies to chlorhexidine
- •pregnancy
结局指标
主要结局
Change of clinical attachment level
时间窗: Baseline, 3 months, 6 months
Measuring the change of the distance between the cemento-enamel junction and the bottom of the periodontal pocket 3 and 6 months after therapy compared to baseline
次要结局
- Change of bleeding on probing(Baseline, 3 months, 6 months)
- Change of gingival index(Baseline, 3 months, 6 months)
- Change of pocket probing depth(Baseline, 3 months, 6 months)
- Change of presence of periodontopathogenic bacteria A. actinomycetemcomitans, P. gingivalis, P. intermedia and T. denticola(Baseline, 3 months, 6 months)
- Change of plaque index(Baseline, 3 months, 6 months)
研究者
Sareh Michael
Dr. med.
RWTH Aachen University