BENEFITS OF A NEW MECHANICAL DECONTAMINATION METHOD, TI-BRUSH, ON THE ADJUNCT TREATMENT OF REGENERATIVE THERAPY OF PERI-IMPLANTITIS LESIONS: 12-MONTH OUTCOMES OF A RANDOMIZED CONTROLLED CLINICAL TRIAL
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Evaluate probing pocket depth changes by decontamination of the implant surface with ultrasonics, 3% H2O2, and Ti-Brush™ at 6 and 12 months.
研究概览
简要总结
Objective:
The objective of this study was to evaluate a new mechanical method (Ti-Brush, Straumann, AG, Basel, Switzerland) of implant surface decontamination.
Material and methods:
A randomized double-blinded controlled clinical trial with a 1-year follow-up it is being carried out. After a hygienic phase, defects were randomly assigned to a control (n=18) or to a test group (n=18). In control group, implant surface was decontaminated both mechanically and chemically with 3% H2O2 and plastic ultrasonic scalers, respectively, while in test group Ti-Brush was added. Infrabony defects in both groups were regenerated with BoneCeramic (Straumann, AG, Basel Switzerland) and collagen barrier membrane Cytoplast (Osteogenics, Lubbock, United States). Clinical and radiographic parameters were measured at baseline, 6, and 12 months after surgery.
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)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy or treated periodontal patients
- •A good level of oral hygiene (Plaque Index ≤ 25%) (O'Leary et al., 1972).
- •Presence of at least one titanium implant exhibiting peri-implantitis (peri-implant bone loss > 30% and Implant PPD ≥ 6 mm with bleeding and/or pus suppuration on probing)
- •Osseous defect had to be circumferential, or present at least two walls and 3mm depth.
- •Presence of >1 mm of keratinized peri-implant mucosa
- •Absence of systemic diseases that could influence the outcome of the therapy.
排除标准
- •Pregnant or lactating women
- •Esthetically compromised patients
- •Patients who received systemic antibiotics in the past 3 months or treatment of peri-implantitis in the last 12 months.
- •Smokers of more than 10 cigarettes a day
研究组 & 干预措施
Titanium brush, H2O2 3%, plastic curettes
干预措施: Titanium brush (Device)
Titanium brush, H2O2 3%, plastic curettes
干预措施: Classic decontamination (Other)
H2O2 3%, plastic curettes
干预措施: Classic decontamination (Other)
结局指标
主要结局
Evaluate probing pocket depth changes by decontamination of the implant surface with ultrasonics, 3% H2O2, and Ti-Brush™ at 6 and 12 months.
时间窗: 6 and 12 months
次要结局
未报告次要终点
研究者
Beatriz de Tapia
Associate professor
Universitat Internacional de Catalunya