Ozonized In-office and Domiciliary Gels vs Chlorhexidine Gel 1% for the Management of Peri-implant Mucositis Sites: a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Bleeding on Probing (BOP%)
研究概览
简要总结
This is a split-mouth randomized controlled clinical trial (RCT). After signing the informed consent, patients satisfying the inclusion criteria will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation with PEEK inserts, manual instrumentation with titanium curettes and air polishing with glycine powder.
After that, the following treatment will be randomly assigned:
- Ozoral Pro and Ozoral gel administration and home application for 2 peri-implant mucositis sites.
- Curasept chlorhexidine gel 1% administration and domiciliary application for 14 days for 2 peri-implant contralateral sites.
The study will last 6 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), after 6 months (T3). Professional hygiene will be performed again at T2 and T3.
At each recall session, the following periodontal clinical indices were collected using a probe on each peri-implant site: BOP, GBI, conditions of the marginal mucosa (swelling and erythema), suppuration, migration of the marginal mucosa, PD, PI ,BS.
详细描述
This is a split-mouth randomized controlled clinical trial (RCT). 30 patients is expected to be enrolled. After signing the informed consent, patients satisfying the inclusion criteria will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation with PEEK inserts, manual instrumentation with titanium curettes and air polishing with glycine powder.
After that, the following treatment will be randomly assigned:
- Ozoral Pro and Ozoral gel administration and home application for 2 peri-implant mucositis sites.
- Curasept chlorhexidine gel 1% administration and domiciliary application for 14 days for 2 peri-implant contralateral sites.
The study will last 6 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), and after 6 months (T3). At T2 and T3, professional hygiene will be performed again.
At each recall session, the following periodontal clinical indices were collected using a probe on each peri-implant site:
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)
盲法说明
Gels concealed
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
- 是
入选标准
- •age 18-70 years
- •presence of 2 peri-implant mucositis sites per side (left and right) with PD > 5 mm
- •no systemic, metabolic and autoimmune disease
- •compliant patients
排除标准
- •neurologic, psychiatric and mental diseases
- •patients taking bisphosphonates in the last 12 months
- •patients taking antibiotics during the study
- •pregnant and breastfeeding women
- •patients undergoing anticancer treatment
结局指标
主要结局
Change in Bleeding on Probing (BOP%)
时间窗: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
Dichotomous scoring (yes/no) of bleeding sites
Change in Suppuration (%)
时间窗: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
Dichotomous scoring (yes/no) of suppurating sites
Change in Gingival Bleeding Index (GBI%)
时间窗: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
Quantitative assessment (percentage) of the bleeding sites (6 per tooth in total). Formula = n ° bleeding sites / n ° probed sites x100
Change in marginal mucosa condition
时间窗: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
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 mucosal margin
时间窗: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
Dichotomous scoring (migrated/non migrated)
Change in Probing Depth (PD)
时间窗: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
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 Plaque Index (PI% - O' Leary Index)
时间窗: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
Evaluation of the presence of plaque on the 4 surfaces of teeth on the total amount of dental surfaces. Formula = n ° sites with plaque / total n ° of dental surfaces x100
Change in Bleeding Score (BS - Mombelli et al.)
时间窗: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
Scoring criteria: 0: no bleeding 1. isolated visible spots 2. blood forms a confluent red line on the mucosal margin 3. profuse and copious bleeding
次要结局
未报告次要终点
研究者
Andrea Scribante
Associate Professor, Principal Investigator
University of Pavia