SPiT-frequency II_Peri-implantitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Peri-implant inflammation
研究概览
简要总结
This is an interventional clinical study on the peri-implant treatment necessary to improve the clinical conditions surrounding dental implants registered with peri-implant inflammation. The focus of this double-armed, examiner blinded, controlled, randomized clinical trial is to examine the effect of short-term increased frequency of a Non-surgical protocol on implants diagnosed with peri-implantitis.
The study is a part of a project assessing the frequency of supportive peri-implant therapy. The current is on non-surgical treatment of peri-implantitis (inflammation and exposed implant surface). The other study is a RCT on treatment of peri-implant mucositis (inflammation and no attachment loss at the implants) and secondary prevention of peri-implant mucositis (REK 790097). Exposure of rough surface may dramatically change the frequency of maintenance needed to improve the inflammatory condition. Thus, a segregation between adequate and low bone level at the implant is necessary.
Subjects with more than one implant and both diagnoses, may be enrolled in both studies, following the frequency of treatment randomized in the peri-implant mucositis study
详细描述
At the screening visit, the following tests and examination will be carried out to screen eligible subjects and provide baseline information for those patients that meet the study criteria:
- Anamnestic information as described in the regular electronic dental journal at the Faculty of Dentistry is collected
- Assessment of clinical registrations; suppuration, plaque, gingival bleeding, PPD, Bleeding index score and presence of keratinized mucosa
- Assessment of existing radiographs to ensure the subject and implants are eligible according to inclusion criteria
- Written and oral information on the study will be given
- Thorough information and instruction in plaque control with tools deemed appropriate by the operator
- Information about the study is given orally and written together with informed consent sheet
Visit 1 Baseline Signed inform consent is collected An experienced, calibrated and board certified specialist in periodontology ("Examiner") performs the following clinical registrations at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) of the included implants: Plaque: the presence or absence recognized by running a probe across the marginal surface of the implant (Mombelli et al. 1987). If plaque is present at the implants to be included, OHI is repeated and Baseline examination is rescheduled PICF (peri implant cravicular fluid): Peri-implant crevicular fluid (PICF) will be collected from one site per implant, at the site with the most severe lesion at the baseline.
Suppuration: the presence or absence after light pressure against gingiva/mucosa or following gentle probing of the peri-implant pocket.
Mucosal bleeding: registered according to the Modified Sulcus Bleeding Index (mBI) (Mombelli et al. 1987).
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)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Subject must be ≥ 20 years, diagnosed with peri-implantitis as defined by the World Workshop 2017 criteria (Berglundh et al., 2018) with a bone level > 3 mm from the expected initial bone level Peri-implantitis: Bleeding after gentle probing at an implant and radiographic bone level > 3 mm
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.
- •HIV positive or other disease severely affecting the immune system
- •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 of inflammation.
- •Anatomical abnormalities.
研究组 & 干预措施
Test. Increased treatment frequency
Submucosal instrumentation will be performed at baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 16 weeks, 24 weeks and 36 weeks
干预措施: Submocosal instrumentation using a ultrasonic device (PEEK). Submucosal cleaning (Procedure)
Control. Conventional frequency
Submucosal instrumentation will be performed at baseline, 12 weeks, 24 weeks and 36 weeks
干预措施: Submocosal instrumentation using a ultrasonic device (PEEK). Submucosal cleaning (Procedure)
结局指标
主要结局
Peri-implant inflammation
时间窗: From baseline to 9 months
To assess the proportion of implants without signs of inflammation (eradication of disease). Inflammation is defined as Bleeding on Probing (BoP) and/or suppuration
次要结局
- Improvement of inflammation severity(From baseline to 9 months)
研究者
Odd Carsten Koldsland
Associate Professor
University of Oslo