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NCT06453278 Clinical Trial

(DDS) in India: a Screening Tool to Identify Prediabetes and Undiagnosed Type 2 Diabetes in Dental Settings

Periodontitis Clinical Trial

Official title:
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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06453278
Other study ID # DR.ADITIPERIO
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 2024
Est. completion date April 2026

Study information
Verified date June 2024
Source Postgraduate Institute of Dental Sciences Rohtak
Contact ADITI SANGWAN, MDS
Phone 09996002408
Email aditidalal86@yahoo.co.in
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 1746
Est. completion date April 2026
Est. primary completion date January 2026
Accepts healthy volunteers No
Gender All
Age group 40 Years to 75 Years
Eligibility Inclusion Criteria: - Inclusion criteria-adults aged = 40 years Exclusion Criteria: - Individuals with existing physician-diagnosed diabetes (of any kind) - Pregnant females

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
India Post Graduate Institute of Dental Sciences Rohtak Haryana

Sponsors (1)
Lead Sponsor Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary To correlate DDS score with HbA1c levels in Indian population. 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. 15-18 months
Primary To determine prevalence of prediabetes and undiagnosed type 2 diabetes in dental patients. 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. 15-18 months
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