Clinical trial NCT06453278: (DDS) in India: a Screening Tool to Identify Prediabetes and Undiagnosed Type 2 Diabetes in Dental Settings
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: PreDiabetes
Type2diabetes
Periodontitis
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 1746
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
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

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria-adults aged ≥ 40 years

Exclusion Criteria:

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

Primary outcomes:
measure: To correlate DDS score with HbA1c levels in Indian population.
timeFrame: 15-18 months
measure: To determine prevalence of prediabetes and undiagnosed type 2 diabetes in dental patients.
timeFrame: 15-18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rohtak
country: India
facility: Post Graduate Institute of Dental Sciences
state: Haryana
Study officials:
affiliation: Post graduate institute of Dental Sciences ROHTAK
name: ADITI SANGWAN, MDS
role: PRINCIPAL_INVESTIGATOR
References: