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临床试验/CTRI/2026/01/101943
CTRI/2026/01/101943尚未招募2 期

Assessment Of Oral Health Status in Prediabetic and Diabetic Patients And Evaluation of the Efficacy Of Dashansamskara toothpaste – A Randomised Controlled Comparative Clinical Study

ALL INDIA INSTITUTE OF AYURVEDA1 个研究点 分布在 1 个国家目标入组 256 人开始时间: 2026年4月18日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
256
试验地点
1

研究概览

简要总结

A total of 256 participants are enrolled and categorised into prediabetic and diabetic groups. Baseline oral examinations are carried out to record common oral health problems associated with dysglycaemia, such as gingival inflammation, periodontal status, plaque accumulation and dental caries. Participants are then randomly allocated to use either Dashansamskara toothpaste (intervention) or a standard comparator toothpaste (control), under supervised instructions for routine oral hygiene practices.

Outcomes are assessed by comparing pre- and post-intervention oral health indices across groups. The study is designed to determine whether Dashansamskara toothpaste offers superior improvement in periodontal and oral hygiene parameters compared to conventional toothpaste, especially in individuals with impaired glucose metabolism where oral infections and periodontal disease risk are higher.

Overall, the study provides clinical evidence on the association between prediabetes/diabetes and oral health and evaluates a traditional formulation toothpaste as a supportive oral care measure in these populations.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
30.00 Year(s) 至 70.00 Year(s)(—)
性别
Female

入选标准

  • Diagnosed cases of Diabetes Mellitus Type 1 & 2 duration more than one year Prediabetic patients of Diabetes Mellitus Type 2 Age group: 30–70 years of both genders Patients willing to give informed consent.
  • Patients with a minimum of 20 natural teeth present (for meaningful plaque and gingival evaluation).
  • HbA1c value available (Above 5.6).

排除标准

  • 未提供

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

SYED FAHEEM ALI

ALL INDIA INSTITUTE OF AYURVEDA , DELHI

研究点 (1)

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