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临床试验/CTRI/2023/12/060880
CTRI/2023/12/060880尚未招募1 期

“COMPARISON OF EFFECTIVENESS OF HUMAN AMNIOTIC MEMBRANE TO PLATELET RICH FIBRIN IN HEALING OF POST EXTRACTION SOCKETS-A RANDOMISED CONTROLLED TRIAL"

Dr.A.Ashwini1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年1月26日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
VAS PAIN SCORE, SWELLING ASSESSMENT,SOFT TISSUE HEALING ASSESSMENT-LAUNDRY-TURBELL HOWLEY INDEX, MOUTH OPENING

研究概览

简要总结

"The aim ofthis randomized controlled trial is to compare the effectiveness of humanamniotic membrane (HAM) to platelet-rich fibrin (PRF) in facilitating thehealing process of post-extraction sockets among dental patients. This studywill assess and analyze the clinical outcomes, including pain management,inflammation reduction, soft tissue healing, and to determine whichregenerative therapy, HAM or PRF, yields superior results in optimizingpost-extraction socket healing."

 OBJECTIVES:

  1. To evaluate andcompare the postoperative pain levels experienced by patients treated with HAMand PRF in post-extraction sockets.

 2. To assess andcompare the degree of postoperative inflammation in the extraction socketsbetween the HAM and PRF treatment groups.

 3. To measure andcompare the rate of soft tissue healing in post-extraction sockets treated withHAM and PRF.

 4. To investigateand compare the incidence of complications, such as infection or adversereactions, associated with HAM and PRF treatments in post-extraction sockets.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Age ≥18 years Non-smokers Presenting with teeth indicated for atraumatic extraction due to Dental caries or periodontitis.
  • COVID Negative individuals Patient who has to undergo extraction of single/ multiple teeth in more than one quadrant ASA I, ASA II.

排除标准

  • Immune compromised Pregnant & Lactating women Non-cooperative History of allergy.
  • Infectious diseases.
  • Any other uncontrolled systemic conditions -.ASA III, ASA IV.

结局指标

主要结局

VAS PAIN SCORE, SWELLING ASSESSMENT,SOFT TISSUE HEALING ASSESSMENT-LAUNDRY-TURBELL HOWLEY INDEX, MOUTH OPENING

时间窗: DAY 1, DAY 3 AND DAY 7

次要结局

  • SWELLING ASSESSMENT,MOUTH OPENING(DAY 1, DAY 3 AND DAY 7)

研究者

发起方
Dr.A.Ashwini
申办方类型
Other [self]

研究点 (1)

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