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临床试验/CTRI/2026/03/107142
CTRI/2026/03/107142尚未招募2 期

Comparative Evaluation of Demineralized Freeze-Dried Bone Allograft with and without fisetin gel in the treatment of Class II Furcation Defects: A Randomized Controlled Trial.

self1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年6月25日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
50
试验地点
1

研究概览

简要总结

This study will include patients visiting the department of Periodontics and Implantology diagnosed with Stage III Periodontitis and exhibiting Class II furcation defects. Two sites in each patient will be assigned randomly for sampling.

It will be conducted in Department of Periodontics and Implantology, after receiving informed consent from the patient. All the clinical and radiographical parameters will be evaluated at baseline after which the sites in the patients will be randomly and equally divided into Test and Control groups to be treated with Fisetin gel with DFDBA and DFDBA alone respectively in Class II furcation defects in Stage III Periodontitis patients. The study will be initiated after clearance from the Institutional Ethics Committee. For each patient two sites will be randomly assigned as:

Group I: (Test Group) – Stage IIIPeriodontitis exhibiting Class II furcation defects to be treated with DFDBA with Fisetin gel**.**

Group II: (Control Group) - Stage IIIPeriodontitis exhibiting Class II furcation defects to be treated with DFDBA alone

Pre-surgical Hygiene Therapy

Initial therapy will consist of detailed oral hygiene instructions and Scaling and root planing. Prior to initiating the study, its purpose and design will be explained and written informed consent will be signed by every patient. The patients will be followed up after 21 days to assess oral hygiene status.

Surgical procedure: Under local anesthesia, full thickness mucoperiosteal flaps will be reflected and granulation tissue will be debrided. The root surfaces will be scaled and planed. In Group I the Class II furcation defects will be treated with DFDBA alone while in Group II the Class II furcation defects will be treated using DFDBA with Fisetin gel. The flaps will be sutured back to their original position. Periodontal dressing will be placed at the surgical sites.

Post-surgical Care: Patient will be placed on antibiotics and analgesics. Sutures will be removed after 7 days. Clinical results will be evaluated at 3 and 6 months post-operatively and radiographic evaluation will be performed at 6 months post-operatively by CBCT.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
30.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1 Patients with Stage III periodontitis as assessed by Probing Pocket Depth more than equal to 6mm, interdental Clinical Attachment Level more than equal to 5 mm and Horizontal Probing Depth more than equal to 2mm.
  • 2 Presence of bilateral Class II furcation defects.

排除标准

  • 1 Patients with history of systemic diseases, allergies or drug usage 2 Patients who have undergone periodontal treatment in previous 6 months 3 Pregnant and lactating females 4 Smokers or tobacco chewers.

研究者

发起方
self
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Nazish Akhtar

Ranjeet Deshmukh dental college and research center

研究点 (1)

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