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临床试验/CTRI/2025/10/095998
CTRI/2025/10/095998尚未招募不适用

Evaluation and comparison of the effects of antibiotics loaded A-PRF placed in extraction sockets on bone formation, implant stability and insertion torque in early implant placement at 8 Weeks - A Randomized Controlled Trial

Dr Putta Sri Lakshmi Prasanna Anjaneyulu1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年10月30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
36
试验地点
1
主要终点
histomorphometric analysis

研究概览

简要总结

This study is a randomized,parallel group, multiple arm study, comparing the safety and efficacy of  amoxicillin/clavulanic acid and clindamycin as an agents in  local  drug delivery evaluating soft and hard tissue healing ,this study contains one control and two experimental groups, comparing 0.5 ml of amoxicillin/clavulanic acid(1.2)gm  in experimental group one and 0.5 ml of clindamycin(600mg/4 ml) in experimental group two, loaded into the A-PRF as local drug delivery placed into the extraction sockets without any postoperative antibiotics compared with control group where A-PRF alone is  placed in the extraction sockets with post operative antibiotics prescribed. Primary out come is bone healing assessment (histomorphometric analysis) by bone coring at the time of dental implant placement ,secondary outcomes are insertion torqe at the time of implant placement, implant stability at 0,1and 3 months compared in both experimental and control groups.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

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

入选标准

  • 1.American Society of Anesthesiologists (ASA) -1 category 2.Bilateral or unilateral with one or more teeth advised for extraction in the premaxillary region.

排除标准

  • 1.Patients subjected to radiotherapy in the head and neck.
  • 2.Patients with poor compliance and smokers 3.Medical conditions or medications known to alter soft tissue or bone healing 4.Systemic infections 5.Roots extending into maxillary sinus 6.Dehiscence in buccal cortical plates after extraction 7.Patient on systemic antibiotics.

结局指标

主要结局

histomorphometric analysis

时间窗: 2 months after extraction,while placing dental implant.

次要结局

  • insertion torque.(2 months at the time of implant placement.)
  • implant stability(0,1 and 3 months.)

研究者

发起方
Dr Putta Sri Lakshmi Prasanna Anjaneyulu
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Putta Sri Lakshmi Prasanna Anjaneyulu

Vishnu Dental College.

研究点 (1)

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