The Adjunctive Effect of a Titanium Brush in the Non-Surgical Treatment of Peri-Implantitis: a Randomized Multi-Center Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Pocket depth changes
研究概览
简要总结
Peri-implantitis is a plaque-associated condition occurring around dental implants, characterized by inflammation in the peri-implant mucosa and loss of supporting bone. To stop this progression, mechanical debridement of biofilm and calculus is commonly used to treat peri-implant lesions as well as the use of adjunctive measures such as titanium brushes. As observed, they improved plaque removal when compared with steel curettes alone. Therefore, it is of interest to evaluate the impact of this procedure in terms of clinical, radiographic and microbiological outcomes to assess their efficacy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients with ≥18 years of age.
- •Ability to understand all the study procedures and to comply with them along the entire study period. Ability and willingness to give written informed consent.
- •An adequate level of oral hygiene (plaque index ≤ 25%) (O'Leary et al., 1972).
- •Treated periodontal disease.
- •Presence of at least one titanium implant with peri-implantitis [i.e., presence of bleeding and/or suppuration on gentle probing with probing depth of ≥6 mm, and progressive bone loss. In the absence of initial radiographs, a bone level ≥2 mm apical to the most coronal part of the intrabony portion of the implant will be used as threshold of disease (Romandini et al., 2021)].
- •Horizontal and vertical peri-implant bone defects.
- •Implant function time ≥ 1 year.
- •Presence of ≥2mm of keratinized peri-implant mucosa.
- •Screw-retained single and multiple restorations.
排除标准
- •Untreated periodontitis.
- •Smokers > 10 cigarettes per day.
- •Local or systemic diseases that would interfere with routine periodontal therapy (i.e., uncontrolled diabetes mellitus, cancer, HIV, chronic high-dose steroid therapy, metabolic bone disease, radiation, immunosuppressive disease, hepatic dysfunction, immunosuppressive disease, autoimmune disease).
- •Pregnant or lactating women.
- •Previous surgical and non-surgical treatment of affected implants at least 12 months prior to the beginning of the study.
- •Radiographic peri-implant bone loss > two-thirds.
- •Mobility of the implant.
- •Known allergy or intolerance to macrolides.
- •Use of systemic antibiotics during the last 3 months.
- •Need of endocarditis prophylaxis.
研究组 & 干预措施
Control Group
Participants will receive submucosal debridement alone
干预措施: Submucosal debridement (Device)
Control Group
Participants will receive submucosal debridement alone
干预措施: Submucosal debridement + titanium brushes (Device)
Test Group
Participants will receive submucosal debridement and titanium brushes
干预措施: Submucosal debridement (Device)
Test Group
Participants will receive submucosal debridement and titanium brushes
干预措施: Submucosal debridement + titanium brushes (Device)
结局指标
主要结局
Pocket depth changes
时间窗: 12 Months
The primary outcome variable will be pocket depth changes at 1 year of follow-up.
次要结局
- Microbiological analysis(12 Months)
- Radiographic parameters(12 Months)
- Modified plaque index (mPI)(12 Months)
- Modified bleeding index (mBI)(12 Months)
- Suppuration on probing (SoP)(12 Months)
- Full mouth plaque index (FMPI)(12 Months)
- Full mouth bleeding index (FMBI)(12 Months)
- Mucosal recession (MR)(12 Months)
- Keratinized mucosa (KM)(12 Months)
研究者
Javi Vilarrasa
Clinical Professor
Universitat Internacional de Catalunya