Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453278
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-23
Brief Title:
DDS in India a Screening Tool to Identify Prediabetes and Undiagnosed Type 2 Diabetes in Dental Settings
Sponsor:
Postgraduate Institute of Dental Sciences Rohtak
Organization:
Postgraduate Institute of Dental Sciences Rohtak
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None