Anti-infective Effect of Non-surgical Treatment With and Without Photodynamic
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change of percentage of bleeding on probing sites
研究概览
简要总结
Photodynamic therapy (PDT), also known as photoradiation therapy, phototherapy, or photochemotherapy, involves the use of a photoactive dye (photosensitizer) that is activated by exposure to light of a specific wavelength in the presence of oxygen. In recent years, PDT has been introduced as an important novel disinfection therapy in the field of implant dentistry. The inactivation of microorganisms using PDT has been defined as antimicrobial PDT. PDT has the potential to be an alternative of antibiotics, especially for the treatment of localized infections and oral biofilm. PDT is unlikely to cause bacterial-resistance and is equally effective against antibiotic-resistance and antibiotic-susceptible bacteria.
Inconsistent results have been reported regarding the potential role of PDT as an adjunct to mechanical debridement in the management of peri-implant infection. Thus, the aim of the present trial is to investigate the treatment effect of non-surgical treatment with and without photodynamic therapy on initial peri-implantitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects, ages over
- •Subjects with at least one implant with initial peri-implantitis: PPD of 4-6mm combined with BOP+, bone loss of 0.5-2mm on peri-apical radiographs compared to the time point of restoration placement.
- •Availability for the 12 month duration of the study.
- •Good general health (ASA classification I-II).
- •Signed Informed Consent Form.
排除标准
- •Medically compromised subjects (ASA classification III-V)
- •Pregnant or lactating females.
- •Peri-implant mucositis defined as the absence of radiographic marginal bone loss between restoration placement and pre-screening review.
- •Subjects treated for >2 weeks with any medication known to affect soft tissue condition (e.g. phenytoin, calcium antagonists, cyclosporin, Coumadin and non-steroidal anti-inflammatory drugs) within 1 month of the baseline examination.
- •Unwilling to participate in the study.
研究组 & 干预措施
Test group
Plastic curette will be used to perform the mechanical debridement. Then, the addition photodynamic therapy (PDT) will be performed. This will be performed with a set-up for PDT (HELBO Photodynamic Systems, German).
干预措施: Mechanical debridement (Procedure)
Control group
Plastic curette will be used to perform the mechanical debridement. Then, irrigation (2% chlorhexidine) will be performed at contaminated sites.
干预措施: Mechanical debridement (Procedure)
Control group
Plastic curette will be used to perform the mechanical debridement. Then, irrigation (2% chlorhexidine) will be performed at contaminated sites.
干预措施: Irrigation (Drug)
Test group
Plastic curette will be used to perform the mechanical debridement. Then, the addition photodynamic therapy (PDT) will be performed. This will be performed with a set-up for PDT (HELBO Photodynamic Systems, German).
干预措施: Photodynamic therapy (Device)
结局指标
主要结局
Change of percentage of bleeding on probing sites
时间窗: From baseline to 12 months after treatment
A PQW Williams probe (Hu-Friedy, Chicago Ill, USA)will be used to detect the peri-implant pocket. the percentage of bleeding on probing sites (BOP) will be recorded.
次要结局
- Mucosa recession(From baseline to 12 months after treatment)
- Change of Probing Pocket Depth(From baseline to 12 months after treatment)
- Change of modified plaque index(From baseline to 12 months after treatment)
- Change of clinical attachment level(From baseline to 12 months after treatment)
- Marginal bone loss(From baseline to 12 months after treatment)
研究者
Junyu Shi
Dr.
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University