Healing of Periodontal Pockets Following Treatment With Minimally Non Surgical Approach or Conventional Non Surgical Therapy. A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- Change of Probing Depth (PD) (millimeters)
研究概览
简要总结
This study aims to evaluate the clinical results of non-surgical periodontal therapy performed with micro-instruments compared to traditional approach (standard curettes) after 6 months of follow-up.
The patients enrolled, subject to written informed consent, will be divided into a Test group (T) and a Control group (C) through a randomization process. Both groups will be motivated on the rules of oral hygiene, treated scrupulously and monitored monthly for 6 months, at the end of which the final data will be collected for statistical processing (in particular by analyzing the difference between baseline and after 6 months of the parameter "probing depth" or PD).
详细描述
The aim of the study is to evaluate the clinical results of non-surgical periodontal therapy performed with micro-instruments (micro-curettes) compared to traditional instruments (standard curettes) after 6 months of follow-up.
The proposed clinical trial will be conducted according to the principles of the Declaration of Helsinki on experimentation involving human subjects.
All subjects will be recruited from the Area of Odontostomatology - Department of Neuroscience, Reproductive and Odontostomatological Sciences of the University of Naples "Federico II".
In a first phase, all patients will be treated with a supragingival scaling session in order to remove plaque and tartar and it will be provided instructions for a correct oral hygiene. After 1 week, the clinical parameters (PD, FMPS, FMBS, CAL, REC) will be recorded and the subjects randomly assigned to the Test (T) or Control (C) group.
In the Test group, after local anesthesia, subgingival mechanical debridement will be performed using an ultrasonic scaler with specific thin tips and Gracey micro-curette to minimize soft tissue trauma.
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
- None
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
- 是
入选标准
- •Untreated patients diagnosed with severe/advanced periodontitis with slow/moderate rate of progression
- •Age > 18 years
- •Patients at least 10 teeth per arch
- •Presence at least of two teeth with PD > 5 mm per quadrant
- •Single-rooted teeth or multi-rooted without furcation involvement
排除标准
- •Patients with systemic diseases
- •Pregnant or lactating
- •Tobacco smokers (<10 cigarettes/day)
- •Previous periodontal treatment in the last 2 years
- •Prolonged antibiotic treatment or anti-inflammatory treatment within 6 months prior to periodontal therapy
- •Furcation involvement
- •Acute periodontal or endodontic abscesses
- •Third molars
研究组 & 干预措施
Gracey micro-curettes
Subgingival mechanical debridement will be performed using an ultrasonic scaler with specific thin tips and Gracey micro-curette.
干预措施: Gracey micro-curettes (Procedure)
Standard Gracey curettes
Subgingival mechanical debridement will be performed using a conventional ultrasonic scaler and standard Gracey curettes.
干预措施: Standard Gracey curettes (Procedure)
结局指标
主要结局
Change of Probing Depth (PD) (millimeters)
时间窗: baseline, 1 week after supragingival scaling, 6 months after non-surgical periodontal therapy
The distance from gingival margin to the bottom of the pocket
次要结局
- Change of Full-Mouth Plaque Score (FMPS) (percentage)(baseline, 1 week after supragingival scaling, 6 months after non-surgical periodontal therapy)
- Change of Full-Mouth Bleeding Score (FMBS) (percentage)(baseline, 1 week after supragingival scaling, 6 months after non-surgical periodontal therapy)
- Change of Clinical Attachment Level (CAL) (millimeters)(baseline, 1 week after supragingival scaling, 6 months after non-surgical periodontal therapy)
- Change of Gingival Recession (GR) (millimeters)(baseline, 1 week after supragingival scaling, 6 months after non-surgical periodontal therapy)
研究者
Luca Ramaglia
Professor Luca Ramaglia
Federico II University