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A Clinical Trial Comparing Preventive and Standard Methods of Dental Care for Improving Oral Health and Blood Sugar Control in Children with Type 1 Diabetes

Effectiveness of Preventive Oral Healthcare Package Versus Conventional Method of Oral Healthcare on Oral Health Status and Glycemic Control among Children with Type 1 Diabetes Mellitus: A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/074335
Enrollment
70
Registered
2024-09-25
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

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

Conditions

Health Condition 1: K025- Dental caries on pit and fissure surface

Interventions

Intervention1: Preventive Oral Healthcare Package: Standard Dental Care + Preventive Oral Healthcare Package including anticipatory guidance, health education animation video for children, pamphlets

Sponsors

Rashmi Misra
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects of either sex between the age group of 6 to 14 years, diagnosed with Type 1 Diabetes Mellitus 2.Patient diagnosed with Type 1 Diabetes Mellitus for at least 6 months back

Exclusion criteria

Exclusion criteria: 1.Patients with known history of any other systemic diseases 2.Presence of periapical pathological lesions 3.Patients who underwent dental treatment in the past 6 months 4.Presence of congenital dental disorders

Design outcomes

Primary

MeasureTime frame
Changes in oral health status, oral hygiene practices and caries incidence (incipient caries) in intervention groupTimepoint: Assessments will be conducted at 1 month, 3 months and 6 months after implementation of Preventive Oral Healthcare Package—

Secondary

MeasureTime frame
Improvement of glycemic levels in intervention group, changes in utilization of dental services and OHRQoL in intervention groupTimepoint: Assessments will be conducted at 1 month, 3 months and 6 months after implementation of Preventive Oral Healthcare Package—

Countries

India

Contacts

Public ContactDr Rashmi Misra

Maulana Azad Institute of Dental Sciences

vikrantmohanty@gmail.com9654700983

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026