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临床试验/CTRI/2025/06/088385
CTRI/2025/06/088385尚未招募Phase 3 4

Comparison Of Efficacy Of Gelfoam Soaked In Diclofenac Placed Inside Extraction Socket With Oral Diclofenac In Postoperative Analgesia.”– A RANDOMISED SPLIT MOUTH STUDY

Dr Vini D Machchhar1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年6月18日最近更新:
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试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
The benefit is it helps determine the optimal route for diclofenac delivery based on factors like bioavailability and patient tolerance.
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

  1. The need for the current study is to examine and assess efficacy of diclofenac gel foam  placed  in extraction sockets as an alternative to oral analgesic. This study will provide with new route of drug administration and avoid problems people face with taking oral medicines like gastritis, ulcerations. Here we will do the trial in 20 patients in which one side when tooth is extracted oral diclofenac will be given and after 7 days when other side extraction is done gelfoam soaked in diclofenac will be given and assessed for pain and healing.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
14.00 Year(s) 至 70.00 Year(s)（—）
性别
All

入选标准

  • •1.Patients with BILATERAL SYMMETRICAL MAXILLARY OR MANDIBULAR teeth indicated for extraction.
 2.Patients undergoing intra-alveolar extraction within 10 minutes duration.

排除标准

  • •Patients with known allergy to NSAIDS.

  • •Pregnant women.

  • •Patients on any other analgesics or corticosteroids.

  • •Patients with history of systemic diseases like bronchial asthma, epilepsy, and emotional and psychosomatic disorders.

  • •Patients unwilling to consent for the study.

结局指标

主要结局

The benefit is it helps determine the optimal route for diclofenac delivery based on factors like bioavailability and patient tolerance.

时间窗: Pain will be assessed for 7 days regularly and will be recorded | Healing will be recorded at 7 days post extraction

次要结局

  • The need for the current study is to examine and assess efficacy of diclofenac gel foam placed in extraction sockets as an alternative to oral analgesic.


研究者

发起方
Dr Vini D Machchhar
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Vini D Machchhar

Yenepoya dental college

研究点 (1)

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