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临床试验/CTRI/2024/04/066218
CTRI/2024/04/066218尚未招募2 期

Comparative evaluation of efficacy of herbal toothpaste tablets over standard toothpaste in reduction of plaque and gingivitis- A randomized controlled clinical trial

Dr. Haritha Avula1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2025年5月1日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
28
试验地点
1
主要终点
1. Plaque Index (PI): Quigley Hein with Turesky modification

研究概览

简要总结

Gingivitis is a non- specific inflammatory lesion in response to the accumulation of oral biofilm and is a necessary precursor to periodontitis. Regular oral hygiene practices could significantly reduce plaque accumulation and gingival inflammation. Toothpaste is the most widely utilized and an effective oral hygiene aid. Toothpaste tablets are a relatively new form of toothpaste that can be a viable alternative to conventional dentifrice.

Tablets are more environmentally friendly in comparison to toothpaste. Tablets are a dry formulation containing all the ingredients required for tooth care. Chewable toothpaste tablets have the advantage of being able to be unpacked and put into the mouth, then chewed off and brushed with a wet toothbrush.

The use of herbal products in dentifrice is proving to be a potential and effective competitor to conventional synthetic compounds.

In light of the above advantages, the present study attempts to compare and evaluate the efficacy of commercially available herbal toothpaste tablets and regular toothpaste in the reduction of plaque and gingivitis.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Males or females ≥ 18 years of age with a minimum of 25 teeth
  • Baseline mean whole-mouth plaque index ≥ 1.0
  • Baseline mean whole-mouth modified gingival index ≥ 1.0
  • Ability to provide written informed consent and comply with study visits as described in the protocol, and
  • Availability for follow up via telephone.

排除标准

  • Pregnant females
  • Participation in another clinical trial
  • History of periodontitis
  • History of any systemic diseases or conditions.

结局指标

主要结局

1. Plaque Index (PI): Quigley Hein with Turesky modification

时间窗: Baseline | 15th day | 30th day

2. Modified Gingival Index (MGI)

时间窗: Baseline | 15th day | 30th day

3. Modified Sulcus Bleeding Index (mSBI)

时间窗: Baseline | 15th day | 30th day

次要结局

  • Efficacy of herbal toothpaste tablets compared to conventional toothpaste.(1 month)

研究者

发起方
Dr. Haritha Avula
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Haritha Avula

SRI BALAJI DENTAL COLLEGE

研究点 (1)

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