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临床试验/CTRI/2025/03/083579
CTRI/2025/03/083579尚未招募不适用

Comparison of the effectiveness of two different toothpastes formulation in the reduction of plaque and gingival inflammation among 6-12 years old children -A randomized controlled trial

self1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年4月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
self
入组人数
60
试验地点
1
主要终点
improvement in Plaque , gingival bleeding and ph

研究概览

简要总结

The study is a randomised , double blind, parallel group, multicentre trial, comparing the efficacy of two toothpastes formulations with controlled group in plaque  control and gingival bleeding in children from aged 6years to 12 years. The salivary ph of this children will also be assessed. The primary outcome measures the antiplaque efficacy , reduction in gingival bleeding and salivary ph. The evaluation will be assessed in baseline, 7thday, 21st days.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Investigator 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

  • Healthy participants without any systemic condition.
  • participants without any oral prophylaxis procedure from 6 months.

排除标准

  • medically compromised children Periodontally compromised children.

结局指标

主要结局

improvement in Plaque , gingival bleeding and ph

时间窗: improvement in Plaque , gingival bleeding and ph in baseline , 4th week, 8thweek

次要结局

  • improvement in salivary ph(baseline , 7thday , 21st day.)

研究者

发起方
self
申办方类型
Research institution and hospital

研究点 (1)

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