SPiT-frequency; the Effect of Increased Frequency of Intervention, Using Chitosan Brushes, on Post-surgical Peri-implant Inflammation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 主要终点
- Eradication of disease
研究概览
简要总结
This pilot study is an interventional clinical study on the supportive peri-implant treatment (SPiT) necessary to maintain/ improve the clinical conditions surrounding a dental implant following surgical treatment of peri-implantitis. The focus of this pilot, double arm, split-mouth, single centre, controlled, randomised clinical study is to examine the effect of short-term increased frequency of a SPiT-protocol.
详细描述
Patients with surgically treated peri-implantitis enrolled in a maintenance program at the Specialist clinic, Institute for Clinical Dentistry, Dental Faculty, University of Oslo, will receive SPiT by the use of an oscillating chitosan brush (LBC, BioClean, Labrida AS, Oslo, Norway). Subjects with at least two not-adjacent implants of similar brand and defect configuration registered with suppuration or Bleeding index score 3-2 (Roos-Jansaker et al., 2007) on at least 1 of 6 surfaces (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) will be invited to participate in the current pilot study.
Baseline examinations and treatment:
Radiographs of the implants showing clear projections of the implant threads at the mesial and distal surfaces will be taken using standard Eggens holders
The following clinical registrations will be performed at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) of the included implants by the blinded examiner:
Suppuration: the presence or absence after light pressure against gingiva/mucosa or following gentle probing of the peri-implant pocket.
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
- Single (Outcomes Assessor)
盲法说明
The assessor will not participate in the treatment, is blinded to what implant receives which treatment and leaves the room following examination prior to treatment
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must be ≥ 20 years,
- •Subjects must have received surgical treatment of peri-implantitis as defined by the World Workshop 2017 criteria (Berglundh et al., 2018).
- •Subjects have to present inflammation (suppuration or BoP 3-2) at more than one implant of similar implant brand, with similar defect type (Schwarz et al., 2007), and defect severity.
- •The implants must not be replacing adjacent teeth (minimum space for one tooth/implant between test and control.
排除标准
- •• Previous radiotherapy in the affected area, current use of chemotherapy, systemic long-term corticosteroid treatment.
- •No pregnant or nursing subjects.
- •< class 2 according to the ASA (American Society of Anesthesiologists) physical status classification.
- •Registered implant bone loss with exposed modified surface < 2.0 mm.
- •If examiners/operators agree the placement of the implant (angle, position, proximity to adjacent implant or tooth) or suprastructure was suboptimal and considered to play a major role in the development and sustain the peri-implant disease.
- •Anatomical abnormalities
- •clinical exclusion criteria specific to the disease/condition
- •specific concomitant treatment with other devise, mouthrinse or systemic antibiotics
- •participation in any other clinical study within the last month
- •inability to comprehend and respond to the quality of life questionnaire
结局指标
主要结局
Eradication of disease
时间窗: 9 months
Proportion of implants without signs of inflammation defined as BoP and/or suppuration (eradication of disease)
次要结局
- Reduction in inflammation,(9 months)
- Radiographic changes(9 months)
- Morbidity, patient centered outcomes(9 month)
- Implant survival(9 month)
研究者
Odd Carsten Koldsland
Associate professor
University of Oslo