Efficacy of Hybenix and Chlosite Gels in Peri-implantitis Sites: a 9-month Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in marginal mucosa condition
研究概览
简要总结
The present study is a randomized clinical trial (RCT). Patients responding to the inclusion criteria will be included. The following peri-implant indexes will be collected: Bleeding On Probing, Gingival Bleeding Index, Marginal Mucosal Conditions (swelling and erythema), Suppuration, Mucosal margin migration, PPD Probing Pocket Depth, Plaque Index, Bleeding Score, radiographic bone loss.
After the peri-implant evaluation, patients will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation with PEEK inserts, manual instrumentation with teflon curettes and air polishing with glycine powder.
After that, the sample will be randomly divided into 2 groups based on thein-office assigned treatment:
- Chlosite® gel application in the peri-implant sulcus
- Hybenix® gel application for 30 s followed by rinsing of the peri-implant sulcus.
The study will last 9 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), after 6 months (T3) and after 9 months (T4).
In each time frame, indexes collection and nonsurgical debridement will be performed.
详细描述
The present study is designed as a randomized clinical trial (RCT) to evaluate the clinical efficacy of two adjuvant gels in the treatment of perimplantitis.
Patients responding to the inclusion criteria will be included in the study. The following peri-implant indexes will be collected:
- BOP (Bleeding On Probing)
- GBI (Gingival Bleeding Index)
- Marginal Mucosal Conditions (swelling and erythema)
- Suppuration
- Mucosal margin migration
- PPD (Probing Pocket Depth)
- PI (Plaque Index)
- BS (Bleeding Score)
- Radiographic bone loss
After the peri-implant evaluation, patients will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation with PEEK inserts, manual instrumentation with teflon curettes and air polishing with glycine powder.
After that, the sample will be randomly divided into 2 groups based on thein-office assigned treatment:
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, 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 at least one peri-implant site with perimplantitis diagnosed according to the latest Classification of Periodontal and Peri-Implant Diseases and Conditions [Berglundh et al., 2018]
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
研究组 & 干预措施
Chlosite
Clinical application of Chlosite gel.
干预措施: Chlosite gel (Other)
Hybenix gel
Clinical application of Hybenix gel.
干预措施: Hybenix gel (Other)
结局指标
主要结局
Change in marginal mucosa condition
时间窗: Baseline, 1, 3, 6 and 9 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
Marginal mucosal migration
时间窗: Baseline, 1, 3, 6 and 9 months.
Dichotomous scoring (yes/no)
Change in BOP - Bleeding On Probing
时间窗: Baseline, 1, 3, 6 and 9 months.
Dichotomous scoring (yes/no)
Change in GBI - Gingival Bleeding Index (percentage)
时间窗: Baseline, 1, 3, 6 and 9 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, 6 and 9 months.
Dichotomous scoring (yes/no)
Probing Depth
时间窗: Baseline, 1, 3, 6 and 9 months.
Evaluation (in mm) of the depth of the mucosal sulcus, through a millimeter periodontal probe; it is detected from the mucosal margin to the bottom of the peri-implant sulcus, evaluated at 6 sites.
Change in BS - Bleeding Score
时间窗: Baseline, 1, 3, 6 and 9 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
Change in Radiographic bone loss (percentage)
时间窗: Baseline, 1, 3, 6 and 9 months.
Quantitative evaluation of the bone loss evaluated on intraoral x-rays.
Change in PI - Plaque Index (percentage)
时间窗: Baseline, 1, 3, 6 and 9 months.
Evaluation of the presence of plaque on the 4 surfaces of teeth on the total amount of dental surfaces.
次要结局
未报告次要终点
研究者
Andrea Scribante
Associate Professor, Principal Investigator
University of Pavia