Split Mouth Comparison of Minimally Invasive Non Surgical Therapy Versus Conventional Scaling and Root Planing for Treatment of Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of diseased sites
研究概览
简要总结
Minimally invasive non-surgical therapy (MINST) is a new approach towards regeneration of deep periodontal defects. Important part of MINST procedure, besides usage of magnification loupes and piezo-electric devices seems to be the usage of special mini-curettes, originally mini-five and after mini-five of Hu-Friedy. So far only descriptive data about the clinical effects of such procedure are available and comparative studies that would include other treatment alternatives are lacking. Therefore, the aim of our study is, on split-mouth model, to compare the number of diseased sites (defined by probing depth ˃ 4 mm and bleeding on probing) after conventional non-surgical therapy and MINST with the usage of special mini-curettes. In addition, new 3D parameters obtained from 3D optical scanning will be developed for evaluation of volume changes of soft tissues.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Evaluator different to care provider
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
- •periodontitis Stage III, grade B/C
- •at least 20 teeth
- •at least 9 teeth (excluding molars) in the upper jaw
- •without FPD, implants
- •without occlusal trauma signs
- •no pathology of endodontic origin
- •without chronic systemic diseases
- •no periodontal treatment in the last 6 months
排除标准
- •poor oral hygiene (PI > 20% at evaluation)
- •antibiotic treatment in the last 6 months or during the observation period
- •pregnant women, lactation, serious chronic systemic diseases, medication with known influence on periodontium or wound healing
研究组 & 干预措施
MINST
Usage of magnification loupes, specific thin and delicate tips together with piezoelectric device and specifically designed Hu-Friedy "mini five", "micro mini five", and "after five" Gracey curettes under local anaesthesia.
干预措施: MINST (Procedure)
Conventional SRP
Conventional non-surgical mechanical treatment using piezoelectric device (PiezoLED, Kavo) and standard Gracey curettes under local anaesthesia.
干预措施: Conventional SRP (Procedure)
结局指标
主要结局
Number of diseased sites
时间窗: 3 months, 6 months, 12 months
Difference in No of Sites with PPD (probing pocket depth) \> 4 mm and BOP (bleeding upon probing)
次要结局
- CAL(3 months, 6 months, 12 months)
- PPD(3 months, 6 months, 12 months)
- REC(3 months, 6 months, 12 months)
- VOL(1 week, 1 month, 3 months, 6 months, 12 months)
研究者
Rok Gašperšič
Assist. Prof.
University of Ljubljana