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

Postgraduate Institute of Dental Sciences Rohtak

Status: Not yet enrolling

Conditions: Periodontitis; Type2diabetes; PreDiabetes

Study type: Observational

Funder types: Other

Identifiers

NCT06453278

DR.ADITIPERIO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,746 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Inclusion criteria-adults aged ≥ 40 years

Exclusion criteria

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

Trial design

1,746 participants in 1 patient group

The study group will comprise of consenting adults aged 40 years and above.

Description:

A) INTERVIEW Demographic data, family history of type 2 diabetes mellitus and periodontal treatment history is obtained. BODY MASS INDEX (BMI) CALCULATION C) ORAL EXAMINATION-POCKET PROBING DEPTH (PPD) MEASUREMENT PPD Measurement of PPD will be done using a periodontal probe and mouth mirror. Measurement will be done on all teeth present in the mouth (except third molars) at six sites per tooth: mesio-buccal, mid-buccal, distobuccal, mesio-lingual, mid-lingual and distolingual. The number of sites with ≥5-mm probing pocket depth will be recorded on the DDS proforma. The total DDS point score will be obtained by adding all individual variable scores, ranging from 0 to 22. BIOCHEMICAL MEASUREMENT ( HbA1c levels in blood): All participants will be asked for providing blood sample for evaluation of HbA1c levels.