Clinical and Microbiological Effects of a 0.03% Chlorhexidine Mouth Rinse in the Prevention of Peri-implant Diseases: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Change on bleeding on probing on implants
研究概览
简要总结
Aim: To evaluate the efficacy of a 0.03% chlorhexidine (CHX) and 0.05% cetyl pyridinium chloride (CPC) mouth rinse, as an adjunct to professionally and patient-administered mechanical plaque removal, in the treatment of peri-implant mucositis.
Material and Methods: Patients displaying peri-implant mucositis in, at least, one implant were included in this randomized, double-blinded, clinical trial. Subjects received a conventional professional prophylaxis (at baseline and 6-month visits) and were instructed to regular oral hygiene practices and to rinse, twice daily, during one year, with a 0.03% CHX and 0.05% CPC mouth rinse, or a placebo. Clinical, radiographic and microbiological data were recorded at baseline, 6 and 12 months. Disease resolution was defined as the absence of bleeding on probing (BOP). Repeated measures ANOVA, Student-t and chi square tests were used.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the presence of, at least, one dental implant with clinical signs of peri-implant mucositis, defined as gently bleeding on probing (BOP) and/or suppuration without progressive radiographic bone loss (after at least 1 year of functional loading)
排除标准
- •untreated or recurrent periodontitis [presence of nine or more sites with PD 5 mm and with full mouth bleeding score (FMBS) > 25%];
- •implants affected by peri-implantitis, (BOP and/or suppuration and progressive radiographic bone loss);
- •removable implant-retained prosthesis;
- •history of intake of systemic antibiotics within the previous month or other chronic systemic medications that could interfere with the study outcomes;
- •and women being pregnant or breast-feeding.
研究组 & 干预措施
Placebo
Mechanical treatment + Placebo mouth rinse
干预措施: Placebo (Other)
Chlorhexidine
Mechanical treatment + 0.03% chlorhexidine + 0.05% CPC mouthrinse
干预措施: Chlorhexidine (Other)
结局指标
主要结局
Change on bleeding on probing on implants
时间窗: Change baseline-12 months
Bleeding on probing (BOP) on implants, evaluated dichotomously (presence/absence), considering a positive score when evident bleeding was observed within 15 s after gentle probing (Jepsen et al. 2015) at baseline, 3, 6, 9 and 12 months. Primary outcome would be considered for the change between baseline and 12 months One blinded and calibrated investigator recorded BOP at 6 sites around implants, using a plastic periodontal probe (PCV12, HuFriedy, Chicago, IL, USA) Calibration was achieved in double measurement calibration sessions, with a gold standard, on six randomly selected patients within one week. The inter-examiner agreement resulting in kappa (k) values of 0.78 for BOP).
次要结局
- Plaque on teeth(12 months)
- Probing depth on implants(12 months)
- Crown-length implant(12 months)
- Recession on teeth(12 months)
- Microbiological outcomes_frequency of detection(12 months)
- Bleeding on probing (BOP) on implants(12 months)
- Bleeding on probing (BOP) on teeth(12 months)
- Plaque on implants(12 months)
- Probing depth on teeth(12 months)
- Microbiological outcomes_proportions(12 months)
- Microbiological outcomes_total counts(12 months)
- Radiographic bone loss on implants(12 months)
- Staining(12 months)
- Adverse effect(12 months)