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临床试验/NCT06453278
NCT06453278尚未招募不适用

Validation of Diabetes Risk Assessment in Dentistry Score (DDS) in India: a Screening Tool to Identify Prediabetes and Undiagnosed Type 2 Diabetes in Dental Settings

Postgraduate Institute of Dental Sciences Rohtak1 个研究点 分布在 1 个国家目标入组 1,746 人开始时间: 2024年9月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,746
试验地点
1
主要终点
To correlate DDS score with HbA1c levels in Indian population.

研究概览

简要总结

This study is conducted to evaluate validity of Diabetes Risk Assessment in Dentistry Score (DDS) in Indian population as a screening tool to identify patients with prediabetes and undiagnosed type 2 diabetes in dental setting. The DDS score of the patient will be correlated with the HbA1c levels and periodontal status of the patient. Such a study has been conducted in Germany but none has been validated in Indian population. Hence this study aims to assess the performance of DDS screening tool in Indian population.

详细描述

BACKGROUND- Most of the models for T2DM risk assessment exist for use in medical settings and include data which is commonly unavailable to dentists. To overcome the limitation of applicability of existing diabetes-risk assessment tools in dental settings, the Diabetes Risk Assessment in Dentistry Score (DDS) was developed utilizing measures routinely available to dentists. It has been developed and validated in a German population and found to perform broadly at par with those validated for use in medical settings. RATIONALE-Models developed in a specific population need to be validated in other populations before they can be adopted. The DDS screening tool has not been validated in Indian population till date. OBJECTIVES- To assess performance of DDS screening tool in predicting the risk of prediabetes and type 2 diabetes mellitus among individuals seeking dental consultation in Indian population. METHODS-The study participants will include individuals seeking dental consultation at a university teaching hospital in India. All participants will undergo DDS risk-assessment followed by measurement of serum HbA1c levels to establish diagnosis of health, prediabetes or undiagnosed T2DM. EXPECTED OUTCOMES-It is expected that the DDS screening model performs well in Indian population, with scope for incorporation of the model during regular dental visits.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria-adults aged ≥ 40 years

排除标准

  • Individuals with existing physician-diagnosed diabetes (of any kind)
  • Pregnant females

结局指标

主要结局

To correlate DDS score with HbA1c levels in Indian population.

时间窗: 15-18 months

Consecutive patients visiting the dental clinic will be asked to answer questions regarding symptoms of diabetes and glycemic control in an interview format. Blood samples from the patients will then be collected and Hba1c levels of the participant will be determined.

To determine prevalence of prediabetes and undiagnosed type 2 diabetes in dental patients.

时间窗: 15-18 months

Screening for risk of diabetes will be done by interviewing the patients visiting the dental out patient department. The DDS risk score for the patient will be calculated and prevalence of prediabetic and undiagnosed cases of type 2 diabetes mellitus will be analyzed.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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