Subgingival Mechanotherapy Using a Periodontal Endoscope Compared to Classical Subgingival Mechanotherapy for the Treatment of Periodontitis: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Probing pocket depth (PPD)
研究概览
简要总结
The study aims to comparatively assess clinical parameters, biochemical and microbiological parameters after treatment of periodontitis using subgingival mechanotherapy traditional and subgingival mechanotherapy using a perioscope.
详细描述
Non-surgical treatment is the basic form of disease treatment periodontitis. Its first stage is the mechanical removal of dental plaque along with the control of risk factors. Subgingival mechanotherapy, also known as scaling and root planing (SRP) is the next stage, aimed at the subgingival area. Perioscopy makes possible direct real-time visualization of the root surface during the procedure. The research results published so far indicate improvement or no significant differences clinical parameters after SRP procedure using a perioscope vs traditional subgingival instrumentation. The aim of this study is to indicate, or not, clinical, biochemical (level of pro-inflammatory cytokines) and microbiological (A. actinomycetemcomitans, P. gingivalis, T. denticola) differences after periodontitis treatment using the traditional method vs. using a perioscope.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 20-60; (II)
- •preserved lateral and anterior teeth;
- •no periodontal treatment in the last 12 months;
- •intermediate or advanced periodontitis (Stage II / III / IV)
- •in each quadrant at least three teeth with PPD>5 mm after initial treatment (scaling, motivation, instruction)
排除标准
- •antibiotic therapy in the last 6 months;
- •systemic diseases affecting periodontal tissues;
- •pregnancy or lactation;
- •orthodontic treatment;
- •tooth mobility II / III degree;
- •involvement of third degree furcations according to Hamp classification;
- •endodontic issues
研究组 & 干预措施
Classical subgingival mechanotherapy
Scaling and root planing using ultrasonic scaler and curettes.
干预措施: classical subgingival mechanotherapy (Device)
Subgingival mechanotherapy with perioscopy
Scaling and root planing using ultrasonic scaler and curettes, under the control of a perioscope, enabling real-time, magnified imaging of the root surface.
干预措施: subgingival mechanotherapy with perioscopy (Device)
结局指标
主要结局
Probing pocket depth (PPD)
时间窗: 0 (before), 3 and 6 months after SRP
Distance from the gingival margin to the bottom of the gingival sulcus
Clinical attachment level (CAL)
时间窗: 0 (before), 3 and 6 months after SRP
Distance from the cementoenamel junction to the bottom of the gingival sulcus
Bleeding on probing (BoP)
时间窗: 0 (before), 3 and 6 months after SRP
Percentage of sites with bleeding provoked by applying a probe to the bottom of a sulcus/pocket.
Plaque index (PI)
时间窗: 0 (before), 3 and 6 months after SRP
Percentage of sites with plaque
次要结局
- Gingival thickness (GT)(0 (before), 3 and 6 months after SRP)
- Width of keratinized tissue (KTW)(0 (before), 3 and 6 months after SRP)