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临床试验/CTRI/2026/01/101111
CTRI/2026/01/101111尚未招募4 期

Clinico-Microbiological Evaluation of Doxycyline Infused Titanium-Platelet Rich Fibrin in Surgical Management of Periodontal Pockets Compared to Titanium-Platelet Rich Fibrin Alone: A Randomized Clinical Trial.

Dr. Nikita Jitendra Khode1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年1月29日最近更新:

试验速览

阶段
4 期
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 randomized, single blinded split mouth clinical trial aims to evaluate and compare the clinical and microbiological efficacy of Doxycycline infused Titanium Platelet Rich Fibrin (TPRF) versus TPRF alone when used as an adjunct to open flap debridement (OFD) in the management of deep periodontal pockets. Twenty patients presenting with periodontal pockets measuring more than or equal to 5mm will be enrolled, contributing a total of 40 sites. Following Phase I periodontal therapy and re evaluation, sites will be randomly allocated into test and control groups. Test sites will receive OFD with doxycycline infused TPRF, while control sites will receive OFD with TPRF alone. TPRF will be prepared from autologous venous blood collected in titanium tubes and centrifuged according to a standardized protocol. Clinical parameters including plaque index, gingival index, probing pocket depth, and relative clinical attachment level will be recorded at baseline, 3 months, and 6 months postoperatively. Microbiological evaluation of Porphyromonas gingivalis colony forming units will be performed at baseline and 3 months. The study aims to determine whether doxycycline infused TPRF provides superior clinical and antimicrobial outcomes compared to TPRF alone in periodontal pocket therapy.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

年龄范围
30.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients of both sexes between 30 and 65 years of age with moderate to severe generalized periodontitis.
  • Patients exhibiting atleast two periodontal pockets with a probing pocket depth of more than or equal to 5mm and clinical attachment loss (CAL) of more than or equal to 4mm in any two quadrants.
  • 3.No history of intake of antibiotics or other medications affecting the periodontium in preceding 6 months.
  • 4.Patient willing for surgery and ready to give written consent.

排除标准

  • Systemic illness or diagnosis of heart condition that would require prophylactic antibiotic cover.
  • Smokers, pregnant or lactating patients will be excluded.
  • Patient with any known allergy to any kind of medication.
  • Platelet count less than 1.5 platelets per microliter.
  • Patient with bleeding disorder or anti platelet or anti coagulant therapy.

研究者

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

Dr Nikita Jitendra Khode

SMBT Dental College and Hospital, Sangamner

研究点 (1)

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