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临床试验/CTRI/2026/04/107653
CTRI/2026/04/107653尚未招募Phase 3 4

Comparative Evaluation of Antimicrobial Coated Versus Non-Coated Silk Sutures in Periodontal Flap Surgery: A Randomized Controlled Trial

Dr. Samra Shaikh1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2026年10月1日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
36
试验地点
1

研究概览

简要总结

This study is aTriple-blind randomized clinical trial designed to evaluate and compare clinical healing, plaque accumulation, and microbial colonization associated with ciprofloxacin-loaded gold nanoparticle-coated (CPG-NP), ciprofloxacin-coated, and non-coated 3-0 silk sutures following periodontal flap surgery. The study aims to test the hypothesis that nanoparticle-based antibiotic-coated sutures may provide improved clinical healing and reduced microbial colonization compared with conventional sutures. The primary outcome measures include plaque accumulation assessed using the Visible Plaque Index, early wound healing assessed using the Early Wound Healing Index, and microbial colonization determined by colony-forming unit (CFU) analysis of retrieved sutures on 8th day following periodontal flap surgery for all the groups. The secondary outcome measures include postoperative pain, which will be assessed by the number of analgesic tablets consumed by the patient and by the Visual Analogue Scale (VAS) on the 8th postoperative day following periodontal flap surgery for all the groups.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
25.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patients with age group between 25-50 years of age.
  • Patients indicated for periodontal flap surgery (more than 5mm residual probing depth after Phase 1 therapy)
  • Systemically healthy patients.

排除标准

  • Patients with systemic diseases and those on medication for the same.
  • Pregnant and/or lactating women.
  • Patients with any known allergy to Ciprofloxacin.
  • Patients who have received antibiotics in any form or have undergone major surgical procedures and received antibiotic therapy for the same within the past 3 months.
  • Patients unwilling to participate in the study or those not willing to comply with the follow-up schedule.

研究者

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

Dr Samra Shaikh

JMFs ACPM Dental College

研究点 (1)

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