Treatment of Peri-implantitis by Air-polishing Abrasives and Antiseptics Solutions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Probing Depth
研究概览
简要总结
The goal of this clinical study is to compare the effectiveness of different methods for decontaminating dental implant surfaces in the treatment of peri-implantitis. The main question it aims to answer is:
Which combination of an antiseptic solution and an air-polishing powder is most effective for the non-surgical treatment of peri-implantitis? Researchers will compare three different treatment combinations (Miramistin with sodium bicarbonate, chlorhexidine with erythritol, and Octenisept with glycine) in patients diagnosed with peri-implantitis. Participants will receive the combined treatment at intervals of 7-10 days for one month. The study will assess changes in probing depth, bleeding, and bone loss at 1 and 2.5 months after treatment to determine the most effective and balanced approach for preserving implant surfaces and promoting tissue healing.
详细描述
This is a prospective, interventional study involving 48 patients diagnosed with peri-implantitis.
Groups: Participants were allocated into three groups (n=16 per group) to receive one of three treatment combinations.
Group 1: Treatment with Miramistin solution (0.01%) and air-polishing with sodium bicarbonate powder.
Group 2: Treatment with Chlorhexidine solution (0.05%) and air-polishing with erythritol powder.
Group 3: Treatment with Octenisept solution and air-polishing with glycine powder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 21 and 75 years
- •Presence of at least one dental implant
- •Diagnosis of peri-implantitis defined as probing depth ≥ 6 mm and radiographic bone loss ≥ 3 mm apical to the most coronal portion of the intraosseous part of the implant
- •Ability to attend follow-up appointments for up to 3 months
- •Willingness to participate and provide written informed consent
排除标准
- •Presence of systemic diseases in a decompensated stage (e.g., uncontrolled diabetes mellitus, severe cardiovascular disease, psychotic disorders, active oncological disease)
- •Current or prior use of immunosuppressive drugs, bisphosphonates, high-dose corticosteroids, antipsychotics, or other medications known to negatively affect peri-implant tissue regeneration and healing
- •Pregnancy or lactation
- •Unwillingness or inability to comply with study procedures
- •Peri-implantitis requiring immediate surgical intervention or implant removal at baseline
研究组 & 干预措施
Miramistin + Sodium Bicarbonate
Participants in this arm receive non-surgical treatment for peri-implantitis using a combination of Miramistin antiseptic solution (0.01%) and air-polishing with sodium bicarbonate powder. The treatment is applied at intervals of 7-10 days for a total duration of one month.
干预措施: Miramistin (Drug)
Miramistin + Sodium Bicarbonate
Participants in this arm receive non-surgical treatment for peri-implantitis using a combination of Miramistin antiseptic solution (0.01%) and air-polishing with sodium bicarbonate powder. The treatment is applied at intervals of 7-10 days for a total duration of one month.
干预措施: Sodium Bicarbonate Powder (Procedure)
Chlorhexidine + Erythritol
Participants in this arm receive non-surgical treatment for peri-implantitis using a combination of Chlorhexidine antiseptic solution (0.05%) and air-polishing with erythritol powder. The treatment is applied at intervals of 7-10 days for a total duration of one month.
干预措施: Erythritol Powder (Procedure)
Chlorhexidine + Erythritol
Participants in this arm receive non-surgical treatment for peri-implantitis using a combination of Chlorhexidine antiseptic solution (0.05%) and air-polishing with erythritol powder. The treatment is applied at intervals of 7-10 days for a total duration of one month.
干预措施: Chlorhexidine (Drug)
Octenisept + Glycine
Participants in this arm receive non-surgical treatment for peri-implantitis using a combination of Octenisept antiseptic solution and air-polishing with glycine powder. The treatment is applied at intervals of 7-10 days for a total duration of one month.
干预措施: Octenisept (Drug)
Octenisept + Glycine
Participants in this arm receive non-surgical treatment for peri-implantitis using a combination of Octenisept antiseptic solution and air-polishing with glycine powder. The treatment is applied at intervals of 7-10 days for a total duration of one month.
干预措施: Glycine Powder (Procedure)
结局指标
主要结局
Probing Depth
时间窗: Baseline, 1 month, and 2.5 months after start of treatment
Probing depth measured in millimeters using a graduated periodontal probe (UNC-15) at six sites per implant: mesiobuccal, buccal, distobuccal, mesiolingual, lingual, and distolingual. The mean probing depth per implant is calculated. A reduction in probing depth indicates treatment success.
Bleeding on Probing
时间窗: Baseline, 1 month, and 2.5 months after start of treatment
Presence or absence of bleeding within 30 seconds after gentle probing at six sites per implant. The percentage of sites showing bleeding per implant is recorded. A decrease in bleeding on probing indicates improvement in peri-implant soft tissue health.
次要结局
- Need for Surgical Intervention(From start of treatment through 2.5 months)
- Suppuration(Baseline, 1 month, and 2.5 months after start of treatment)
- Plaque Index(Baseline, 1 month, and 2.5 months after start of treatment)
- Gingival Index(Baseline, 1 month, and 2.5 months after start of treatment)
- Radiographic Bone Loss(Baseline and 2.5 months after start of treatment)
研究者
Elena Strandstrem
PhD candidate
Research Centre for Medical Genetics, Russian Federation