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临床试验/CTRI/2024/10/074804
CTRI/2024/10/074804尚未招募Phase 3 4

Comparison of the effect of Simvastatin impregnated gel foam and Platelet rich Fibrin on post-operative outcomes in patients undergoing extraction of mandibular molars

Datta Meghe Institute of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月15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
40
试验地点
1
主要终点
Simvastatin is better compared to Platelet Rich Fibrin in terms of Bone regeneration and soft tissue healing.

研究概览

简要总结

BackgroundResidual ridge resorption (RRR), which occurs after tooth extraction, is a chronic, continuous, irreversible, and accumulative type of bone resorption.  Because of the continued resorption of alveolar bone, this causes multiple cosmetic and functional challenges in individuals who have missing teeth.  Consequently, in order to maintain the existing alveolar ridge, a great deal of research has been conducted on methods to stop the loss of alveolar bone or encourage the development of new bone. In view of this, a study will be conducted to assess and compare the effectiveness of PRF and Simvastatin in terms of their ability to promote bone regeneration and their ability to repair wounds in the extraction socket of mandibular molars.

Objectives

• To evaluate the effects of Simvastatin-impregnated gel foam on regeneration of bone and wound healing in patients undergoing mandibular molar extractions against those using PRF.

Methods

Procedure will be performed in patients undergoing extraction of mandibular molars. Patients will be divided in 2 groups. Immediately after the extraction, In Group 1, extraction sockets will receive Gel Foam as a carrier for the medication Simvastatin (10 mg, crushed and dispersed into normal saline); in Group 2, PRF will be grafted.

Expected results

For individuals having their mandibular molars extracted, gel foams infused with simvastatin will promote improved wound healing and bone regeneration.

Conclusion

It is hypothesized that Simvastatin impregnated gel foam placed might give better results.In patients having mandibular molar extraction, if Simvastatin Impregnated Gel foam is shown to be superior to PRF in regard to regeneration of bones and wound healing, it will overcome the disadvantage related to PRF i.e, collection of blood via Phlebotomy, cost of Centrifuge machine used to make PRF.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • 1 Patients with ASA Grade I status.
  • 2 Patients between 16-50 years of age undergoing extraction of mandibular molars.
  • 3 Patients indicated for extraction of mandibular molars.
  • 4 Patient willing to participate, draw blood sample.

排除标准

  • Patients with hypertension, diabetes mellitus or any other co morbidities.

结局指标

主要结局

Simvastatin is better compared to Platelet Rich Fibrin in terms of Bone regeneration and soft tissue healing.

时间窗: Sft tissue healing seen on post operative day 2 an day 8. Bone regeneration seen post operatively after 3 months and 6 months.

次要结局

未报告次要终点

研究者

发起方
Datta Meghe Institute of Higher Education and Research
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

SALONI KANABAR

sharad pawar dental college

研究点 (1)

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