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A study of saliva oral bacteria and lip and tongue features in participants including healthy individuals prediabetics and people with type 2 diabetes mellitus including those with high blood pressure and heart disease

The Silent Oral Alarm: A Multiparametric Panel Integrating Oral Microbial and Forensic Markers in Type 2 Diabetes Mellitus - SMF-DM STUDY

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/04/108746
Enrollment
120
Registered
2026-04-20
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E11- Type 2 diabetes mellitus

Interventions

Intervention1: Nil: Nil

Sponsors

Dr Navneet Kaur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Individuals aged 30 to 70 years willing to participate and able to provide written informed consent Participants classified into four groups based on current glycemic status using recent fasting blood glucose and HbA1c values Group I Healthy FPG less than 100 mg per dL and HbA1c less than 5.7 percent Group II Prediabetic FPG 100 to 125 mg per dL and HbA1c 5.7 to 6.4 percent Group III Diabetic Clinically diagnosed type 2 diabetes mellitus with FPG greater than or equal to 126 mg per dL and HbA1c greater than or equal to 6.5 percent Group IV Diabetic with comorbidities Type 2 diabetes mellitus with physician diagnosed comorbid conditions such as hypertension and/or cardiovascular disease confirmed through medical records Individuals capable of providing 2ml unstimulated whole saliva for biochemical and microbial analyses Participants with fixed or removable prosthetic appliances FPD RPD implant supported prostheses will be included and their presence will be recorded and considered during statistical analysis as a potential confounding factor

Exclusion criteria

Exclusion criteria: Individuals with uncontrolled systemic conditions other than diabetes and specified comorbidities that may influence salivary composition or immune response Current smokers tobacco chewers or chronic alcohol users History of antibiotic antifungal or systemic corticosteroid therapy within the past 30 days Pregnant or lactating women Presence of acute oral infections mucosal lesions malignancies or ulcerative conditions at the time of examination Participants currently using medications known to significantly alter salivary flow for example antidepressants antihistamines anticholinergics Individuals with orthodontic appliances that may interfere with plaque accumulation patterns Participants unable or unwilling to adhere to the standardized pre sampling instructions especially required for those wearing removable prostheses

Design outcomes

Primary

MeasureTime frame
To assess and compare salivary parameters including salivary pH salivary flow rate and taste perception across the four study groups To analyze variations in forensic traits specifically lip prints that is cheiloscopic patterns and tongue morphology among the study groups To isolate identify and quantify Streptococcus salivarius and Enterococcus faecalis from saliva samples of all groups through colony counting Gram staining and specific biochemical identification tests Timepoint: At baseline

Secondary

MeasureTime frame
To assess the combined pattern of salivary microbial & forensic parameters across the glycemic spectrum To identify parameters that demonstrate early alterations associated with metabolic dysregulation aiding differentiation between prediabetic diabetic & comorbid diabetic conditions Timepoint: At baseline

Countries

India

Contacts

Public ContactDr Anubha Gulati

Dr. Harvansh Singh Judge Institute of Dental Sciences and Hospital Panjab University Chandigarh

shallygupta72@yahoo.in9914016745

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026