跳至主要内容
临床试验/CTRI/2026/04/108559
CTRI/2026/04/108559尚未招募不适用

Evaluation of Clinical Parameters and Patient-centric Outcomes of Periodontal Flap Closure using Autologous Fibrin Glue and Silk sutures, in Stage II Grade B Periodontitis patients: A Split-mouth Randomized Controlled Trial.

Harshandi Bodele1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年6月10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
40
试验地点
1

研究概览

简要总结

This split-mouth randomized controlled clinical trial evaluates the effectiveness of autologous fibrin glue compared with conventional silk sutures for periodontal flap closure in Stage II Grade B periodontitis patients aged 20–40 years. Sutures, though commonly used, may increase plaque retention, postoperative discomfort, tissue reactivity, and patient anxiety. Autologous fibrin glue, prepared chairside from the patient’s own blood, offers a biological, suture-less alternative that may enhance healing, reduce discomfort, shorten closure time, and improve patient acceptance.

In each participant, two non-adjacent flap surgery sites are randomly allocated to either autologous fibrin glue (test) or silk sutures (control). Primary outcomes include time taken for wound closure, immediate postoperative tissue stability assessed by roll test, and wound healing at 1 week and 1 month using a simplified healing index. Secondary outcomes include patient-centric measures such as anxiety during wound closure, intra-operative and postoperative discomfort, anxiety related to suture removal, and discomfort during suture removal, assessed using the Visual Facial Anxiety Scale.

The study seeks to determine whether autologous fibrin glue provides comparable or superior clinical and patient-reported outcomes as a suture-less flap closure technique. By assessing both clinical parameters and patient experience, this trial aims to identify a more comfortable and efficient method for periodontal flap closure.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Subject aged between 20 to 40 years.
  • Systemically healthy patients.
  • Localized flap surgery indicated in atleast two non-adjacent areas in same arch in same patient, requiring flap surgery in 3 teeth per site.
  • Patient with haemoglobin levels more than 12g/dl.

排除标准

  • Flap surgery requiring regenerative/augmentation procedures.
  • Pregnant and lactating patients.
  • Tobacco chewers and smokers.
  • Anaemic patients.
  • Patient with any bleeding disorder.

研究者

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

Harshandi Bodele

MGV KBH Dental College and Hospital Nashik

研究点 (1)

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