Pilot Study for the Management of Peri-implant Mucositis With Ozone Water Jet: a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Change in BOP - Bleeding on Probing (percentage)
研究概览
简要总结
The aim of this study is to assess if ozonized water can be used for the treatment of peri-implant mucositis in patients with dental implants.
Patients willl undergo professional dental hygiene also with the use of glycine powders, then they will be randomly divided into two groups:
- Trial Group: irrigation of peri-implant periodontium with mucositis with ozonized water.
- Placebo Group: irrigation of peri-implant periodontium with mucositis with water.
Periodontal indices will be recorded at the baseline, after 1 and 2 months. After 1 and 2 months, only glycine powders will be performed, together with ozonized water or water irrigation and the collection of periodontal indices.
详细描述
The aim of this study is to assess if ozonized water can be used for the treatment of peri-implant mucositis in patients with dental implants.
Patients who respond to eligibility criteria and that will sign the informed consent will undergo a professional oral hygiene procedure.
Patients willl undergo professional dental hygiene also with the use of glycine powders. Then, glycine powders air-flow will be administered. Then they will be randomly divided into two groups:
- Trial Group: irrigation of peri-implant periodontium with mucositis with ozonized water.
- Placebo Group: irrigation of peri-implant periodontium with mucositis with water.
Periodontal indices will be recorded at the baseline, after 1 and 2 months. After 1 and 2 months, only glycine powder will be performed, together with ozonized water/water irrigation and the collection of periodontal indices.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of one or more dental implants
- •Presence of peri-implant mucositis at least at one implant
- •Bleeding Score > 0
排除标准
- •Patents without dental implants
- •Presence of systemic diseases
- •Patients with cardiac pacemaker
结局指标
主要结局
Change in BOP - Bleeding on Probing (percentage)
时间窗: Baseline, 1 and 2 months.
Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PD, detected on 6 sites.
Change in BS - Bleeding Score
时间窗: Baseline, 1 and 2 months.
Scoring criteria: * 0: no bleeding; * 1: punctiform bleeding in the site of probing; * 2: bleeding within the gingival border; * 3: bleeding outside the gingival border.
Change in PI - Plaque Index (percentage)
时间窗: Baseline, 1 and 2 months.
Site-specific assessment of the presence or visible plaque detected on 4 sites with a disclosing tables. Percentage of sites with plaque determines the PI%.
Change in PPD - Probing Depth
时间窗: Baseline, 1 and 2 months.
Evaluation (in mm) of the depth of the gingival sulcus, through a millimeter periodontal probe; it is detected from the gingival margin to the bottom of the gingival sulcus of the peri-implant pocket, evaluated at 6 sites.
次要结局
未报告次要终点
研究者
Andrea Scribante
Research Resident, Principal Investigator
University of Pavia