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临床试验/CTRI/2022/10/046385
CTRI/2022/10/046385已完成2 期

Clinical and Microbiological Evaluation of Dental Plaque on topical application of Olive oil, Olive oil with 35% Curcuma zedoaria and Olive oil with 30% Azadirachta indica in hospitalized children: A Randomised Clinical Study

Simron Baishya2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2022年10月15日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
84
试验地点
2
主要终点
The synergistic impact of two herbal oils can reduce plaque, bacterial and fungal growth.

研究概览

简要总结

This is a triple-blinded, randomized clinical study, clinically and microbiologically evaluating dental plaque on topical application of olive oil, olive oil with 35% Curcuma zedoaria and olive oil with 30% Azadirachta indica in hospitalized children. The study would include clinical evaluation of dental plaque in hospitalized children by Silness and Loe plaque index and microbiological evaluation of Streptococcus mutans, Lactobacillus and Candida albicans by CFU count after 24hours, 48hours and 72hours of application of oil/saline.

Need of the study: There have been historical benefits of use of fats and studies on oil pulling in prevention of caries. The local application for vulnerable people needs to be studied. Vulnerable people like hospitalized children & children with special healthcare needs, are often unable to maintain good dental hygiene. They could face a challenge to brush & floss. Under such circumstances, direct application of herbal oil as anti-plaque agent on tooth surface can be beneficial in removing the biofilm and thereby controlling plaque formation and fungal infections. Identifying the potential of medicinal plants as phytochemical compounds can lead to cost effective herbal formulations in the field of dentistry.

Null hypothesis: There is no difference in plaque control after the application of the three products: extra virgin olive oil, extra virgin olive oil with 35% Curcuma zedoaria and extra virgin olive oil with 30% Azadirachta indica when compared with normal saline (control group).

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, Investigator and Outcome Assessor Blinded

入排标准

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

入选标准

  • 1.Children from 3-14 years of age.
  • 2.Children hospitalized for a minimum period of 4days 3.Non ambulatory hospitalized children who cannot brush/expectorate.

排除标准

  • 1.Children who did not give assent 2.Children whose Parents did not give consent 3.Children using oxygen mask 4.Children in ventilator 5.Children in ICU.
  • high risk 6.Children having allergy to Azadirachta or Curcuma.

结局指标

主要结局

The synergistic impact of two herbal oils can reduce plaque, bacterial and fungal growth.

时间窗: Clinical and microbiological response after 24, 48 and 72 hours

The microbial load (Streptococcus mutans, Lactobacillus and Candida albicans) and accumulation of dental plaque would be reduced.

时间窗: Clinical and microbiological response after 24, 48 and 72 hours

次要结局

  • The palatibilty of the product by the patient by Likert scale(Baseline, after 24, 48 and 72hours)

研究者

发起方
Simron Baishya
申办方类型
Other [self]

研究点 (2)

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