Efficacy of nanohydroxyapatite in Periodontal regeneration
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Periodontal regeneration
研究概览
简要总结
Pre-surgical procedures:
Patients fulfilling the inclusion criteria and have willingly given informed consent will be subjected to phase-1 therapy comprising of full-mouth scaling, root planing, and occlusal corrections if required.
The subjects will be monitored for plaque control and tissue response and if found satisfactory will be prepared for surgery. Gingival index and plaque index will be recorded at baseline on the day of surgery. Intraoral radiographs with the grid will be taken by using paralleling technique to record osseous defect depth, Alveolar crest level.
Method:
Following local anesthesia with 2% Lignocaine, using block and infiltration techniques, intra-crevicular incisions will be given to reflect the full thickness mucoperiosteal flaps for defect access and debridement.
The patients will be randomly divided into two study groups by computer alloted method
GROUP-A {Test group}; Intra-bony defects will be filled with injectable nano hydroxyapatite-chitosan scaffold.
GROUP-B {Control group}; Intrabony defects will be filled with nano-hydroxyapatite bone graft.
The surgical flaps will be repositioned and sutured using 4-0 black silk to achieve primary closure.
post-operative instructions will be given.
Post-surgical Evaluation:
Patients will be recalled after 7 days for surgical removal
Recall examinations will be scheduled at 3,6,9 months postoperatively and all the clinical parameters will be recorded
Radiographic parameters(IOPAR with grid) and CBCT will be assessed at baseline and after 9 months
Patients will be monitored periodically for their oral hygiene maintenance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Subjects with more than 20 remaining teeth Subjects with Chronic Periodontitis with Periodontal pocket depth greater than 5mm Systemically healthy subjects with any vertical bone loss.
排除标准
- •Pregnant and lactating mothers, smokers Allergic to chitosan/HAP Compromised immune system Undergone periodontal therapy in previous 6 months Subjects taking medication that could interfere with soft tissue/bone healing.
结局指标
主要结局
Periodontal regeneration
时间窗: Baseline,3,months, 6 months,9months
次要结局
- To reduce Periodontal pocket depth(Baseline,3,months, 6 months,9months)
