Limosilactobacillus Reuteri as an Adjuvant in the Treatment of Peri-implant Mucositis in Total Rehabilitation: an Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Modified bleeding index
研究概览
简要总结
Mechanical debridement is the traditional method for the treatment of peri-implant mucositis and its success depends on the patient's correct oral hygiene. It is believed that probiotics may help by their ability to modulate the oral biofilm, resulting in anti-inflammatory and anti-bacterial plaque action. The aim of this study is to evaluate the adjuvant effect of the probiotic Limosilactobacillus reuteri in the mechanical treatment of peri-implant mucositis. This study aims to include 32 subjects with implant-supported total rehabilitation and peri-implant mucositis, divided into test and control groups, equally subjected to professional mechanical debridement, with the administration of a daily GUM® PerioBalance® lozenge for 30 days added to the test group. Plaque Index, Bleeding Index and probing pocket depth are evaluated before the intervention (baseline) and at 6 and 10 weeks later.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(i) dental implants placed for at least 12 months according to the All-on-4® concept;
- •(ii) removal of the dental prosthesis as part of the conventional implant maintenance protocol;
- •(iii) modified Bleeding Index19 score >0 in at least one implant in the studied rehabilitation;
- •(iv) implants connected to the prosthesis by means of transepithelial abutments;
- •(v) if there were natural teeth in opposing arch, they were periodontally healthy or had been treated for periodontitis and were on periodontal support with residual pockets ≤5mm;
- •(vi) demonstrated previous compliance with oral hygiene appointments; (vii) read and signed the informed consent.
排除标准
- •(i) Peri-implantitis proven clinically (implant mobility, suppuration and/or pocket depth (PD) ≥5mm) and/or radiographically (bone remodeling greater than 2mm in the first year of function20 and mean marginal bone loss greater than 0.2mm for each subsequent year21 in the rehabilitated arch that was intended to be studied);
- •(ii) clinically active peri-implantitis (mobility, suppuration and/or PD ≥5mm) in the opposing arch to the one intended to be studied;
- •(iii) presence of an extra-maxillary/zygomatic implant in the rehabilitated arch that was intended to be studied;
- •(iv) current probiotic supplementation;
- •(v) diabetes mellitus not controlled by medication;
- •(vi) current use of oral hygiene products containing chlorohexidine or essential oils;
- •(vii) special needs individuals who depended on others for their oral hygiene and medication uptake.
结局指标
主要结局
Modified bleeding index
时间窗: baseline, 6 weeks, 10 weeks
Change of the bleeding score on each dental implant from baseline to 6 weeks and from baseline to10 weeks. Modified bleeding index- 0: absence of bleeding; 1: isolated bleeding spots visible; 2: blood forms a confluent red line on margin; 3: heavy or profuse bleeding.
次要结局
- Modified plaque index(baseline, 6 weeks, 10 weeks)
- Probing pocket depth(baseline, 6 weeks, 10 weeks)