Clinical and radiographic evaluation of Calcium phosphate -Poly(lactide co-glycolide) composite graft in the regeneration ofintrabony defects- A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- comparison of bone regeneration between two groups. {test group:Calcium phosphate -Poly
研究概览
简要总结
clinical and radiographic evaluation of Calcium phosphate -Poly(lactide co-glycolide) composite graft in the regenration of intrabony defects -A Randomized Controlled Trial.
2 groups will be taken
6 patients: control group where Calcium phosphate graft will be used
6 patients: test group where Calcium phosphate -Poly(lactide co-glycolide) graft will be used
Cytotoxicity and biocompatibility tests will be conducted in JSS College of pharmacy
The grafts will be surgically placed into intrabony defects and clinical and radiographic parameters will be evaluated at baseline, 3 months, 6 months, 9 months and 12 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Systemically healthy patients, both males and females with age ranging from 35-55 years having chronic generalized periodontitis.
- •Patients having a minimum of two infrabony pockets measuring ≥ 6mm.
- •Consenting patients who are co-operative and ready for regular follow up.
- •more than 20 remaining teeth.
排除标准
- •1.Patients on antibiotic therapy in the previous 6 months.
- •Patients who have undergone periodontal therapy in past six months.
- •Pregnant/lactating women
- •Patients who are medically compromised and are under therapeutic medications that may alter the probability of soft tissue and bone healing.
结局指标
主要结局
comparison of bone regeneration between two groups. {test group:Calcium phosphate -Poly
时间窗: At baseline, 3 months, 6 months, 9 months and 12 months
(lactide co-glycolide)composite bone graft and control group:calcium phosphate bone graft
时间窗: At baseline, 3 months, 6 months, 9 months and 12 months
次要结局
- Comparison of clinical parameters(At baseline, 3 months, 6 months, 9 months and 12 months)