The Evaluation of Clinical, Microbiological and Immunological Parameters After Using Photodynamic Therapy in the Surgical Treatment of Peri-implantitis: Randomized Clinical Trials.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change of bleeding on probing (BOP)
研究概览
简要总结
Photodynamic therapy (PDT) is suggested as an adjuvant treatment method to the surgery in peri-implantitis treatment. The primary goal of peri-implantitis therapy is the removal of the causative bacteria from the implant surface and surrounding tissues in order to improve the process of re-osseointegration and achieve long term implant stability. Accordingly, the aims of the study were to evaluate clinical, immunological and microbiological outcomes after surgical therapy of peri-implantitis following PDT.
详细描述
Treatment procedure
After clinical parameters were recorded and samples were taken, all patients underwent a single episode of non-surgical therapy. It implied a mechanical method for debridement of implants and remaining dentition in order to reduce signs of inflammation. Instructions for oral hygiene were proposed in the same visit.
Peri-implantitis surgical treatment was conducted by one experienced surgeon two weeks after non-surgical therapy. After granulation tissue removal and mechanical implant surface cleaning with graphite curettes (Straumann Dental Implant System Straumann AG, Basel, Switzerland), decontamination of implant surface was conducted. In the study group, for the decontamination of implant surfaces and peri-implant tissues photodynamic therapy was performed (HELBO, Photodynamic Systems GmbH, Wels, Austria), while in the control group, after removal of granulation tissue, 1% gel of chlorhexidine (Chlorhexamed® - Direkt) was put on the implant surface. One minute after exposing the implant surface with CHX, it was irrigated for 1 min by saline. Bone augmentation and bio-resorbable membrane were applied in peri-implant defects using the bovine bone substitute and collagen membrane (Bio-Oss and Bio Gide, GeistlichPharma; Dembone). The mucoperiosteal flaps were repositioned and sutured [17, 19].
Patients were prescribed antibiotics (Amoxicillin, 500 mg, three per day, 5 days). It was recommended that patients don't use mouthwash during the postoperative period.
Clinical, immunological and microbiological parameters were measured and assessed baseline, three, six, 12 and 24 months postoperatively. Immunological parameters (IL-17, IL-1β, IL-6) were analysed by ELISA while microbiological samples were collected before the therapy, during the surgery, and at follow-up periods.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double (Participant, Investigator, Sub-investigator) Single Blind
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •More than 18 years old
- •No periodontal or peri-implant treatment in the last 3 months prior to the study
- •Presence of a minimum of one implant in function more than one year with signs of early and moderate peri-implantitis
- •Prosthetic rehabilitation of the implant with diagnosed peri-implantitis more than 6 months
- •Presence of peri-implant pocket depth more than 4 mm
- •Radiogrpih bone level loss more than 2 mm 7 Positive sign of bleeding on probing with or without suppuration
排除标准
- •Uncontrolled medical conditions
- •Use of systemic antibiotics in the previous 3 months
- •Use of anti-inflammatory drugs in the previous 6 months
研究组 & 干预措施
Study group
In the test group, implant surface decontamination was performed with photodynamic therapy.
干预措施: Photodynamic (PDT) group (Procedure)
Control group
In the control group, implant surface decontamination was performed with 1% chlorhexidine gel.
干预措施: Chlorhexidine (CHX) group (Procedure)
结局指标
主要结局
Change of bleeding on probing (BOP)
时间窗: Change baseline BOP at 24 months
Evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was observed
Change of bleeding on probing (BOP)
时间窗: Change baseline BOP at 12 months
Evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was observed
次要结局
- Change of peri-implant probing depths (PPD)(Change baseline PPD at 24 months)
- Change of clinical attachment gain (CAG)(Change baseline CAL at 24 months)
- Change of peri-implant probing depths (PPD)(Change baseline PPD at 12 months)
- Change of clinical attachment gain (CAG)(Change baseline CAL at 12 months)
研究者
Dragana Rakasevic
PhD, Specialist of periodontology
School of Dental Medicine
