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临床试验/CTRI/2024/01/061671
CTRI/2024/01/061671已完成4 期

Therapeutic effect of topical application of ozone oil in non-surgical extraction- A double blind randomized control trial.

ESIC Dental College1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2024年1月28日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
82
试验地点
1
主要终点
1) reduction in post extraction pain.

研究概览

简要总结

This is interventional double blinded parallel group with placebo control clinical trial where therapeutic effect of local application of ozone oil at dental extraction socket is assessed. Local application of ozone oil at wound have proved to be beneficial in many previous studies. Hence we decided to assess its therapeutic effect on Dental extraction. institutional ethical committee clearance is obtained.  The aim of this study is to assess if local application of Ozone oil provides better healing, less post operative pain and less consumptions of post operative analgesics. All cases will be recruited in this study as per inclusion and exclusion criteria. Procedure will be explained completely to every patient and all the doubts of patients will be answered in their own language. If patient ready to give his/her consent for study then only will be recruited for study after signing of written informed consent. patients and observers are blinded. All the patients will be reviewed on 2nd and 7th day for pain and healing of wound. also will be asked for amount of analgesics consumed till 7th day post extraction. All the data will be collected and will be processed by statistician for final result. if proven to be effective, it can reduce consumption of post operative medications, hence less systemic load. As it is applied locally, no known side effect is mentioned in literature.

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
19.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Healthy individual who have no systemic diseases and indicated for simple dental extraction.

排除标准

  • patient below 18 years.
  • pregnant or lactating women.
  • patient with systemic diseases.
  • patient currently on any medications.

结局指标

主要结局

1) reduction in post extraction pain.

时间窗: 1) Till 7th post operative day. | 2) Till 7th post operative day.

2) reduction in consumption of post analgesics post operatively.

时间窗: 1) Till 7th post operative day. | 2) Till 7th post operative day.

次要结局

  • better healing of extraction socket.(Till 7th post operative day.)

研究者

发起方
ESIC Dental College
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Anunay Pangarikar

ESIC Dental College Kalaburagi

研究点 (1)

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