跳至主要内容
临床试验/CTRI/2024/09/074248
CTRI/2024/09/074248招募中2/3 期

Comparative analysis of the effect of calorie free sweeteners and probiotics on the oral microbial concentration in children: a randomised controlled trial

Saveetha Dental College and Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年10月4日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
Oral microbial concentration assessed through saliva samples

研究概览

简要总结

This randomized controlled trial compares the effects of calorie-free sweeteners (aspartame, stevia, xylitol) and probiotics on oral microbial concentration in children aged 6-12. A total of 120 participants are randomly assigned into four groups of 30. Group 1 receives aspartame, Group 2 receives stevia, Group 3 receives xylitol, and Group 4 receives probiotics. The intervention lasts for 4 weeks, with follow-up assessments at baseline, 1 week, and 4 weeks. Saliva samples are collected at baseline, 1 hour after consumption, and at subsequent time points to measure oral microbial concentration using quantitative PCR (qPCR) and microbial culture techniques.

Secondary outcomes include changes in gingival health and caries status, evaluated through the gingival index, Oral Hygiene Index (OHI), and International Caries Detection and Assessment System (ICDAS) index. Children with systemic diseases, recent dental treatments, or allergies to probiotics/sweeteners are excluded. Compliance is monitored by parents using a "sweet diary."

The study provides insight into the potential effects of calorie-free sweeteners and probiotics on children’s oral microbial health and dental outcomes, including caries risk and gingival health.

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 12.00 Year(s)(—)
性别
All

入选标准

  • Children with no systemic diseases Children not currently taking antibiotics or other medications affecting oral health Children whose parents are willing for informed consent.

排除标准

  • Children with known allergies to probiotics or sweeteners Children with significant dental treatments within the past three months Children who do not consume more than 65% of the time frame (will be eliminated from the study group).

结局指标

主要结局

Oral microbial concentration assessed through saliva samples

时间窗: Baseline - 1 hour after consumption, 1 week, 4 weeks

次要结局

  • Gingival index(Oral hygiene index (OHI))

研究者

发起方
Saveetha Dental College and Hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Aardra B S

Saveetha Dental College and Hospital

研究点 (1)

Loading locations...

相似试验