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临床试验/CTRI/2024/05/067132
CTRI/2024/05/067132尚未招募2/3 期

Comparative evaluation of anticariogenic efficacy of Ocimum basilicum varnish and fluoride varnish among 6 to 8 years old school children: A double-blind randomized controlled trial

Dr Siva Shankkari T1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年5月24日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Reduction of ICDAS score and Plaque Streptococcus mutans count

研究概览

简要总结

Topical fluoride has been widely used in preventing dental caries. However, its deleterious effects on dental, skeletal, cardiovascular, gastrointestinal and neurological tissues emphasize on the need of an alternative dental varnish which is safe and biocompatible. Recent approaches in modern medicine aim to derive ingredients from nature as they are organic, biocompatible and less expensive. In this study, Ocimum basilicum seeds commonly called as ‘Sweet basil” are used for formulation of a herbal varnish as they are rich source of calcium and phosphorous and possess antibacterial properties. Dental caries is considered as the most important global oral health burden affecting 60-90% of school-aged children with 78% of prevalence in India. Poor oral health in children leads to poor development due to malnutrition and affects overall general health. In this study, 6-8 year old children are included as this age group falls in the second window of infectivity making them more susceptible to caries. Thus, it is the need of the hour for a non-toxic, economical and herbal dental varnish to prevent dental caries from an early age.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
6.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • Children with atleast one initial enamel caries as per ICDAS scoring in age group of 6-8 years.
  • Parents/guardians who are willing to give written consent.

排除标准

  • Teeth with any GIC restorations, pit and fissure sealants.
  • Development alterations like hypoplasia or fluorosis.
  • Children with any history of allergy reactions to the herbal medicaments or varnish.
  • Children under medical treatment or taking medication in any form.
  • Children unwilling to complete the treatment protocol.

结局指标

主要结局

Reduction of ICDAS score and Plaque Streptococcus mutans count

时间窗: Baseline and 4 months

次要结局

未报告次要终点

研究者

发起方
Dr Siva Shankkari T
申办方类型
Other [Self funded]
责任方
Principal Investigator
主要研究者

Dr Siva Shankkari T

KAHERS KLE VK Institute of dental sciences

研究点 (1)

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