Evaluation of Photodynamic Treatment FOTOSAN® Efficacy in Periodontology
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change of periodontal pocket depth
研究概览
简要总结
Periodontitis are infectious and inflammatory diseases of gum and tooth supporting tissues leading to tooth loss and oral disability. Twenty to 30 percents of patients treated for periodontal diseases display more or less pronounced persistence of periodontal tissue infection, inflammation, and destruction. The therapeutic additional value of photodynamic anti-infectious treatment remains controversial. The objective of this study is to evaluate the mid-term effect of the photodynamic device Fotosan®630 on severe periodontitis treatment outcomes and to define its specific therapeutic indications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 40 years
- •signed informed consent
- •generalized severe chronic periodontitis
- •patient with at least 24 teeth
- •more than 30% of sites with clinical attachment loss >5mm- at least 5 sites with pocket depth >4mm per quadrant- at least one molar per quadrant- evidenced bone loss on radiographs- bleeding on probing ≥30%
排除标准
- •aggressive periodontitis
- •smoking more than 10cig/day
- •patient with endocarditis risk or need of antibiotic prophylaxis
- •pregnant women
- •patient included in other trials
- •patient under guardianship
- •patient treated with antibiotics, anti-inflammatory, and other drugs (inhibitors of calcium channels...) influencing periodontal status within 6 months before examination
- •patient suffering from diseases influencing periodontal status (diabetes...)
- •patient periodontally treated with root planing or periodontal surgery within 1 year before examination
- •patient with scheduled extensive prosthetic treatment
- •patient with a high haemorrhagic risk (INR>4)
- •impossible patient cooperation
结局指标
主要结局
Change of periodontal pocket depth
时间窗: 6 months
Study period for each participant : 6 months Inclusion period: 24 monthTotal study duration: 30 month
次要结局
- Change of periodontal clinical attachment level, gingival inflammation and dental plaque indexChange of periodontal microflora(6 months)