Efficacy of 0.12% Chlorhexidine Gluconate for Peri-implant Mucositis and Gingivitis: a Randomised Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 主要终点
- Bleeding on probing
研究概览
简要总结
The purpose of this study is to analyze the efficacy of 0.12% chlorhexidine gluconate as a chemical adjuvant for the treatment of peri-implant mucositis in single implants compared with homologous teeth with gingivitis, in a non-surgical treatment protocol with a six-month follow-up.
详细描述
The following clinical parameters were evaluated in both test and control groups; visible plaque index (VPI) and gingival bleeding index (GBI) were obtained for full mouth (IPV and ISG) and for each implant and teeth (VPI implant; VPI teeth; GBI implant; GBI teeth). For statistical purposes, percentages of faces with biofilm and marginal bleeding at teeth and implants were calculated. These parameters were evaluated at baseline and at one, three and six months post-therapy.
Probing depth (PD implant; PD teeth) and bleeding on probing (BOP implant; BOP teeth) were collected for all implants and teeth with a North Carolina periodontal probe at six sites. After data collection, an arithmetic averages of the sites with bleeding on probing and probing depths were calculated at baseline, three and six months. The peri-implant and periodontal biotype for each implant and teeth was rated as thin or thick, according to probe transparency during probing depth.
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
- Double (Participant, Investigator)
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
- •Systemically-healthy partially edentulous patients rehabilitated with functional dental implants and prostheses for at least 1 year;
- •Patients had been diagnosed with peri-implant mucositis, probing depth up to 5 mm, bleeding on probing and no radiographic evidence of bone loss beyond the first two threads of the implant;
- •Patients had been diagnosed with gingivitis in homologous teeth to implants.
排除标准
- •Non-smokers and not in maintenance therapy;
- •Periodontal treatment during the last six months;
- •Have not used antimicrobial (systemic or topical), anti-inflammatory or immunosuppressive drugs during the six months preceding the study.
研究组 & 干预措施
Chlorhexidine gluconate
15 ml of solution every 12 hours, twice a day, 30 minutes after brushing, for 14 days
干预措施: Chlorhexidine gluconate (Drug)
Placebo
15 ml of solution every 12 hours, twice a day, 30 minutes after brushing, for 14 days
干预措施: Placebo (Drug)
结局指标
主要结局
Bleeding on probing
时间窗: six months
次要结局
- Probing depth(baseline and at three and six months)
研究者
Karyna de Melo Menezes
Principal Investigator
Universidade Federal do Rio Grande do Norte