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

June 7, 2024 updated by: Postgraduate Institute of Dental Sciences Rohtak

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

1746

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • Haryana
      • Rohtak, Haryana, India, 124001
        • Post Graduate Institute of dental sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study participants will be drawn from consecutive eligible adults attending the regular out patient department (OPD) of PGIDS, Rohtak. All individuals will be required to provide written informed consent before enrolment in the study. Inclusion criteria-adults aged ≥ 40 years Exclusion criteria-

  1. Individuals with existing physician-diagnosed diabetes (of any kind)
  2. Pregnant females

Description

Inclusion Criteria:

  • Inclusion criteria-adults aged ≥ 40 years

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Dental Sciences Rohtak

Investigators

  • Principal Investigator: ADITI SANGWAN, MDS, Post graduate institute of Dental Sciences ROHTAK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

May 23, 2024

First Submitted That Met QC Criteria

June 7, 2024

First Posted (Actual)

June 11, 2024

Study Record Updates

Last Update Posted (Actual)

June 11, 2024

Last Update Submitted That Met QC Criteria

June 7, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DR.ADITIPERIO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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