Clinical Evaluation of Bioactive Composite (Chitra-HABG) along with Concentrated Autologous Platelets in the Treatment of Periodontal Defects
试验速览
- 阶段
- 1/2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Soft tissue parameters 1.Probing pocket depth. 2. Gingival margin level 3. Clinical attachment level
研究概览
简要总结
The proposed study is on the efficacy of surgical grafting of periodontal defects when autologous platelet concentate is used along with a bioactive composite graft. A total of 40 subjects, who voluntarily consent to participate, will be recruited. There will be 2 treatment groups (as below), wherein each group will have 20 treatment sites and 20 control sites. In the first group, graft material (Chitra-HABG, the Bioactive Composite Granules developed at SCTIMST) will be placed in the periodontal defect. Balanced control sites will be identified in the same patient in which, the conventional open-flap debridement will be given. In the second group, the graft material (Chitra-HABG, the Bioactive Composite Granules) mixed with autologous platelets isolated through the CAPS Platelet Isolation Kit will be placed. As in the first group, balanced control sites will be identified in the same patient in which, the conventional open-flap debridement will be given. The safety and efficacy of the grafts will be assessed through clinical and radiographic methods.
研究设计
- 分配方式
- Random Number Table
- 盲法
- Participant Blinded
入排标准
入选标准
- •Patients with normal health and with no complicating medical history that would contra-indicate routine periodontal surgery.
- •Patient age between 35and 44 years.
- •Presence of two or more sites in different quadrants with probing pocket depth ranging between
- •10 mm. The sites should exhibit clinical and radiographic evidence of intrabony defects.
- •Defects at balanced sites so that one could be used as control.
- •No history of allergy to any systemic analgesics or antibiotics.
排除标准
- •Patients with systemic diseases.
- •Pregnant and lactating women.
- •Smokers and those with the habit of using tobacco.
- •Patients on anti-platelet drugs.
结局指标
主要结局
Soft tissue parameters 1.Probing pocket depth. 2. Gingival margin level 3. Clinical attachment level
时间窗: Immediate Pre-operative, 1 month, 3 months, 6 months, 9 months and 12 months
次要结局
- Digital IOPA radiograpgh(Immediate Pre-operative, 1 month, 3 months, 6 months, 9 months and 12 months)