Comparative Treatment Evaluation of Human Mandibular Class II Furcation Defects Using Bone Grafts and Antimicrobial Photodynamic Therapy-A Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- percentage of bone fill
研究概览
简要总结
This is a surgical comparative clinical trial which aims to assess class II buccal furcation defects treated with Xenograft alone or preceded by antimicrobial photodynamic therapy.
详细描述
To test the efficacy of photodynamic therapy (Indocyanine green) along with placement of xenograft (Cerabone®-Natural bovine bone grafting material, Botiss biomaterials) to treat a class II furcation defects. The topical study was designed as a randomized controlled, single blinded (patient), split mouth clinical trial with 14 participants. In the control group, the defects were filled with xenograft (Cerabone®) whereas the test group received photodynamic therapy (Indocyanine green) in addition to grafting. Radiovisiography technique was used to observe the possible changes in the furcation region at baseline and 9 months postoperatively.
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
- None
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy subjects Age group of 25-60 years Presence of class II furcation defect on buccal surfaces of mandibular molars as determined by clinical and radiographic evaluation.
- •Vertical probing depth (VPD) ≥4mm Horizontal probing depth (HPD) ≥4 mm Gingival margin (GM) coronal to or at the level of the roof of the furcation
排除标准
- •Current and former smokers Administration of antibiotics in the last 6 months History of any periodontal therapy in the past 6 months Known allergic responses to bovine derived graft materials and photosensitizers.
- •Pregnant and lactating women.
结局指标
主要结局
percentage of bone fill
时间窗: 9 months
amount of bone formation
次要结局
- Clinical efficacy(9 months)