Clinical Comparison Between Chlorhexidine Gel and Peribioma Periogel in Patients With Peri-implant Mucositis: a Split-mouth Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in marginal mucosa condition
研究概览
简要总结
The aim of this study is to evaluate the efficacy of non-surgical periodontal therapy with supportive home oral care for the treatment of peri-implant mucositis.
Patients with bilateral implants with peri-implant mucositis will undergo professional dental hygiene with ultrasonic handpiece and manual scaler, followed by the application of glycine Airflow powders. Then, patients will be randomly divided into two groups: the Trial Group will undergo a split-mouth application of chlorhexidine gel 1% for quadrants 1 and 4 and of Biorepair Periogel 0.12% for quadrants 2 and 3, with one daily home application for the following 15 days after the visits and the use of Biorepair Parodontogel toothpaste; the control Group will not use any gels.
The improvement of peri-implant mucositis will be evaluated between the two groups and differences between the two gels will be assessed, if present.
详细描述
The aim of this study is to evaluate the efficacy of non-surgical periodontal therapy with supportive home oral care for the treatment of peri-implant mucositis.
Patients with bilateral implants with peri-implant mucositis will undergo professional dental hygiene with ultrasonic handpiece and manual scaler, followed by the application of glycine Airflow powders. Then, patients will be randomly divided into two groups:
- Trial Group: split-mouth application of chlorhexidine gel 1% for quadrants 1 and 4 and of Biorepair Periogel 0.12% for quadrants 2 and 3. Home oral care will be continued with 1 application per day of the two gels for the following 15 days after the visits for the same quadrants, and the use of Biorepair Parodontogel Toothpaste.
- Control Group: no application neither of chlorhexidine gel nor of Biorepair Periogel.
The improvement of peri-implant mucositis will be evaluated between the two groups and differences between the two gels will be assessed, if present, evaluating periodontal indices at the baseline, after three months and after six months.
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
- •Adult patients (18-70 years)
- •Bilateral presence of peri-implant mucositis
- •Patients with high compliance
排除标准
- •Patient with cardiac pacemaker
- •Patients suffering from psychological, neurological or psychiatric disorders
- •Patients suffering from systemic, metabolic or autoimmune diseases
- •Pregnant women
结局指标
主要结局
Change in marginal mucosa condition
时间窗: Baseline, 1, 3 and 6 months.
Scoring criteria: * 0: normal mucosa * 1: minimal inflammation with color change and minor edema * 2: moderate inflammation with redness, edema and glazing * 3: severe inflammation with redness, edema, ulceration and spontaneous bleeding without probing
Change in BOP - Bleeding On Probing
时间窗: Baseline, 1, 3 and 6 months.
Dichotomous scoring (yes/no)
Change in mucosal margin
时间窗: Baseline, 1, 3 and 6 months.
Dichotomous scoring (migrated/non migrated)
Probing Pocket Depth
时间窗: Baseline, 1, 3 and 6 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 or periodontal pocket, evaluated at 6 sites.
Change in GBI - Gingival Bleeding Index (percentage)
时间窗: Baseline, 1, 3 and 6 months.
Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PPD, detected on 6 sites. The number of bleeding sites is divided per the total number of probed sites; the ratio is multiplied X 100.
Change in suppuration
时间窗: Baseline, 1, 3 and 6 months.
Dichotomous scoring (yes/no)
Change in PI - Plaque Index (percentage)
时间窗: Baseline, 1, 3 and 6 months.
Evaluation of the presence of plaque on the 4 surfaces of teeth on the total amount of dental surfaces.
Change in BS - Bleeding Score
时间窗: Baseline, 1, 3 and 6 months.
Scoring criteria: * 0: no bleeding * 1: isolated visible spots * 2: blood forms a confluent red line on mucosal margin * 3: heavy or profuse bleeding
次要结局
未报告次要终点
研究者
Andrea Scribante
Research Resident, Principal Investigator
University of Pavia