Efficacy of a Natural Bioactive Gel as an Adjunct to Standard Therapy in the Treatment of Peri-Implantitis: A Randomized Controlled Split-Mouth Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in peri-implant Modified Plaque Index (mPI)
研究概览
简要总结
This study is a randomized controlled clinical trial using a split-mouth design to evaluate the effectiveness of a natural bioactive gel (Sterify Gel®) as an adjunct to standard non-surgical therapy for peri-implantitis. Peri-implantitis is an inflammatory disease that affects the tissues around dental implants and can lead to bone loss and implant failure. The goal of the study is to determine whether the application of Sterify Gel®, which contains polyvinyl polymers, hydroxytyrosol, magnesium ascorbyl phosphate, and nisin, can improve clinical outcomes when used in addition to conventional mechanical debridement and air-polishing.
The trial will include 20 patients, each with at least two implants in different quadrants affected by peri-implantitis. One implant will be treated with standard therapy plus the gel (test site), while the other will receive standard therapy alone (control site). Clinical outcomes will be measured over a 9-month period, including plaque levels, bleeding on probing, probing depth, suppuration, and bone loss. The results will help assess whether this gel enhances the effectiveness of routine non-surgical peri-implantitis treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients aged between 18 and 70 years
- •Presence of peri-implantitis involving at least two dental implants located in different quadrants
- •Presence of bleeding and/or suppuration on probing
- •Increased probing depth (PD) and radiographic bone loss compared to previous examinations
- •In the absence of previous clinical data: PD ≥ 6 mm and bone loss ≥ 3 mm apically from the coronal portion of the intraosseous implant area (radiographically assessed)
- •Willingness and ability to comply with study protocol and follow-up visits
- •Written informed consent provided
排除标准
- •Patients with cardiac pacemakers or other implanted electronic devices
- •Neurological or psychiatric disorders that may interfere with study participation
- •Systemic diseases, metabolic disorders, or autoimmune conditions
- •Pregnancy or lactation Current participation in other clinical trials
研究组 & 干预措施
Sterify Gel + Non-Surgical Therapy
This arm receives standard non-surgical peri-implantitis treatment (mechanical debridement, air-polishing with erythritol and glycine) plus the application of Sterify Gel®, a mucoadhesive hydrogel containing polyvinyl polymers, hydroxytyrosol, magnesium ascorbyl phosphate, and nisin, applied in the peri-implant pocket using a sterile needle.
干预措施: Sterify Gel (mucoadhesive bioactive gel) (Drug)
Sterify Gel + Non-Surgical Therapy
This arm receives standard non-surgical peri-implantitis treatment (mechanical debridement, air-polishing with erythritol and glycine) plus the application of Sterify Gel®, a mucoadhesive hydrogel containing polyvinyl polymers, hydroxytyrosol, magnesium ascorbyl phosphate, and nisin, applied in the peri-implant pocket using a sterile needle.
干预措施: Standard Non-Surgical Peri-Implantitis Therapy (Procedure)
Non-Surgical Therapy Only
This arm receives standard non-surgical peri-implantitis treatment only, including mechanical debridement with ultrasonic and manual instruments, and air-polishing with erythritol and glycine powders. No adjunctive gel is applied.
干预措施: Standard Non-Surgical Peri-Implantitis Therapy (Procedure)
结局指标
主要结局
Change in peri-implant Modified Plaque Index (mPI)
时间窗: At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)
The Modified Plaque Index (mPI) is a semi-quantitative index used to assess the presence and accumulation of bacterial plaque around dental implants. Scores are recorded at six peri-implant sites per implant using a 3-point scale, where 0 indicates no plaque, 1 indicates plaque detectable only with a probe, and 2 indicates plaque visible to the naked eye. For each implant, the mean score is calculated. At the patient level, the percentage of sites with a score greater than or equal to 1 is also calculated. The primary outcome is the change in mPI between baseline and the final follow-up, comparing treated and control sites.
次要结局
- Change in percentage of peri-implant sites with Bleeding on Probing (BoP)(At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4))
- Change in peri-implant Bleeding Score (BS)(At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4))
- Change in mean peri-implant Probing Depth (PD)(At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4))
- Change in percentage of peri-implant sites with Suppuration (Suppuration Index, SI)(At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4))
- Change in peri-implant implant mobility score(At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4))
- Change in percentage of peri-implant sites with Gingival Bleeding Index (GBI)(At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4))
- Change in percentage of peri-implant sites with Marginal Mucosal Conditions (MMC)(At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4))
- Change in percentage of peri-implant sites with Mucosal Margin Migration (MMM)(At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4))
- Change in peri-implant Radiographic Bone Loss (RBL)(At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4))
研究者
Andrea Scribante
Associate Professor, Principal Investigator
University of Pavia