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临床试验/CTRI/2025/06/089860
CTRI/2025/06/089860尚未招募不适用

Effect of Dant Kanti Natural Toothpaste in Chronic Periodontitis: Prospective, open-label, single-arm, observational study

Patanjali Research Foundation3 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2025年7月21日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
55
试验地点
3
主要终点
Change in Gingival Index and Plaque Index

研究概览

简要总结

This single arm, open label, observational, prospective study will evaluate the effect of Dant Kanti Natural Toothpaste in chronic periodontitis conditions. Subjects will be screened based on Inclusion/Exclusion criteria and enrolled after obtaining written Informed consent. The eligible subjects will be assigned to use Dant Kanti Natural toothpaste for the next 14 days from the day of enrolment and Gingival Index, Plaque Index, Oral Health Impact Profile 14 and microbial count will be evaluated.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • At least 20 functional teeth Good general health The subject is able and willing to provide consent.

排除标准

  • Systemic antibiotic treatment 30 days before enrolment or during the trial Individuals with known allergies to any of the ingredients in the toothpaste Not willing to stop sporadic use less frequently than daily of any other oral hygiene product dentifrices or oral mouthwash during the study period Any condition the investigator identifies that can confound the participants ability to properly participate in the study Pregnancy or planned pregnancy The subjects not willing to provide consent Habit of betel quid chewing.

结局指标

主要结局

Change in Gingival Index and Plaque Index

时间窗: from Day 1 Day 7 and Day 14

次要结局

  • Change in the microbial count(from Day 1 Day 7 and Day 14)
  • Changes in the Oral Health Impact(Profile-14)

研究者

申办方类型
Research institution

研究点 (3)

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