Biodegradable Gelatin Sponge Loaded With Beta-Tricalcium Phosphate Sponges Incorporating Concentrated Growth Factors in the Treatment of Intra-bony Pocket Randomized Clinical and Radiographic Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- bleeding on probing
研究概览
简要总结
This clinical study aimed to evaluate the efficacy of biodegradable gelatin sponge loaded with Beta-tricalcium phosphate socked in concentrated growth factors in the treatment of periodontal intra-bony defects, as compared with biodegradable gelatin/beta-tricalcium phosphate sponges alone.
详细描述
40 intra-bony defects in 40 patients will be selected from outpatient clinic of Oral Periodontology Clinic Faculty of Dentistry, Tanta University to participate in this study. Each defect had intra-bony depth > or = 4 mm and probing pocket depth (PPD) > or = 6 mm. Patients will be randomly assigned to either test or control group. 20 patients will be treated by surgery plus biodegradable gelatin/beta-tricalcium phosphate sponges alone.
(control group), the other 20 patients will be treated with the same surgical technique plus biodegradable gelatin sponge loaded with Beta-tricalcium phosphate socked in concentrated growth factors (test group).
Gingival index (GI), bleeding on probing, Probing pocket depth and clinical attachment level (CAL) will assessed at baseline, 3, and 6 months at the site to be treated. Cone beam radiographs evaluation will be taken at baseline, and 6 months after surgery.
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)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •systemically healthy patients were selected
- •patients who had not received any medications for the previous six months that may interfere with periodontal tissue health or healing.
- •Patients should demonstrate their ability to maintain good oral hygiene
排除标准
- •Smokers and pregnant patients.
- •Medically compromised patients and systemic conditions precluding periodontal surgery.
- •Subjects who do not comply with oral hygiene measures as evidenced in recall visits.
- •Sites with tooth mobility
- •Restoration or caries in the site to be treated or non-vital tooth
- •Restoration or caries in the site to be treated or non-vital tooth
结局指标
主要结局
bleeding on probing
时间窗: 6 months
bleeding on probing will be recorded at baseline, 3, and 6 months at the site to be treated
clinical attachment level
时间窗: 6 months
clinical attachment level will be recorded at baseline, 3, and 6 months at the site to be treated
gingival index
时间窗: 6months
gingival index will be recorded at baseline, 3, and 6 months at the site to be treated
cone beam x ray measuring defect area
时间窗: 6 months
defect area will be recorded at baseline, and 6 months at the site to be treated
probing pocket depth
时间窗: 6 months
probing pocket depth will be recorded at baseline, 3, and 6 months at the site to be treated
cone beam x ray measuring bone density
时间窗: 6 months
bone density will be recorded at baseline, and 6 months at the site to be treated
次要结局
未报告次要终点
研究者
malak mohamed shoukheba
associate prof.
Tanta University