跳至主要内容
临床试验/CTRI/2023/09/057967
CTRI/2023/09/057967尚未招募2/3 期

Comparative Evaluation of two commercially available toothpastes on the reduction of Glucosyltransferase Enzyme - a Randomized Controlled Trial

Saveetha Dental college and Hospital1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2023年1月11日最近更新:
适应症

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
88
试验地点
1
主要终点
Glucosyltransferase enzyme absorption index by ELISA

研究概览

简要总结

Dental caries is a prevalent and widespread oral health problem worldwide. It is a multifactorial disease characterized by the demineralization of tooth enamel and the subsequent formation of cavities. Dental caries is primarily caused by the interaction of several factors, including bacteria, diet, and host susceptibility. To combat dental caries, various preventive strategies have been developed, including regular dental hygiene practices (such as brushing and flossing), dietary modifications (reducing sugar intake), and the use of fluoride-containing products (to strengthen enamel and inhibit acid production). Additionally, efforts have been made to target the enzymatic activity of glucosyltransferase, as inhibiting this enzyme’s function could potentially reduce the formation of dental plaque and mitigate the risk of tooth decay. The study is being conducted to evaluate the effect of two commercially available toothpastes on Glucosyltransferase enzyme activity and their anti-caries effect on teeth.

研究设计

研究类型
Interventional
分配方式
Stratified block randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 54.00 Year(s)(—)
性别
All

入选标准

  • Participants with atleast 1 active carious lesion.

排除标准

  • Medically compromised individuals.
  • Patients with a history of allergic reactions.
  • Patients undergoing orthodontic treatment.

结局指标

主要结局

Glucosyltransferase enzyme absorption index by ELISA

时间窗: Baseline, 6 months

次要结局

  • Assessment of microbial count in terms of colony forming units(Baseline, 3 months, 6 months, 9 months, 12 months)
  • Assessment of DMFS status using ICDAS-II scoring(Baseline, 3 months, 6 months, 9 months, 12 months)

研究者

发起方
Saveetha Dental college and Hospital
申办方类型
Research institution and hospital

研究点 (1)

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