跳至主要内容
临床试验/CTRI/2021/03/032008
CTRI/2021/03/032008尚未招募不适用

Efficacy of nanohydroxyapatite in Periodontal regeneration

JSS Academy of Higher Education and Research Institute1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年3月25日最近更新:

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)

研究者

发起方
JSS Academy of Higher Education and Research Institute
申办方类型
Research institution and hospital

研究点 (1)

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