Skip to content

Immune Markers and Cell Activity in Kids with Early Tooth Decay

Evaluation of Proliferating Cell Nuclear Antigen (PCNA) and Anti-Inflammatory Markers in Immune Response Associated with Early Childhood Caries - A Clinico immunological study - nil

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094427
Enrollment
36
Registered
2025-09-08
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Health Condition 1: K029- Dental caries, unspecified

Interventions

Intervention1: group 1 ECC with swelling/abscess (extraoral or intraoral) Group 2 ECC with multiple decayed teeth more than 10 Group 3 ECC with multiple decayed teeth less than 10 : Clinical & History

Sponsors

saveetha dental college
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed with Early Childhood Caries (ECC) based on AAPD criteria. Study groups: Group 1: ECC with clinical signs of swelling (e.g., dental abscess or localized soft tissue inflammation). Group 2: ECC without swelling. Group 3: Caries-free, healthy children (control group). Medically healthy with no systemic or immune-compromising diseases. Informed written consent obtained from parents or legal guardians.

Exclusion criteria

Exclusion criteria: Presence of systemic illness (e.g., diabetes, cardiac disorder or immunodeficiency diseases). History of congenital anomalies or genetic disorders. Teeth indicated due to trauma or developmental defects unrelated to caries. Parents/guardians refusing consent or unwilling to comply with study procedures.

Design outcomes

Primary

MeasureTime frame
Evaluation of the expression levels of Proliferating Cell Nuclear Antigen PCNA in children with early childhood caries compared to caries free children Assessment of anti inflammatory cytokine markers such as Interleukin 10 IL10 and Transforming Growth Factor Beta TGF beta in both study and control groups Detection and quantification of gene expression through Polymerase Chain Reaction PCR analysis Immunohistochemical analysis of tissue samples to localize and quantify PCNA and anti inflammatory marker expression Correlation of molecular and immunohistochemical findings with the clinical severity of early childhood cariesTimepoint: 6 months

Secondary

MeasureTime frame
Correlation between PCNA and cytokine expression levels to explore the relationship between cell proliferation and immune regulation in ECC. Assessment of the association between biomarker expression levels and clinical caries severity (e.g., dmft/dmfs scores) for potential diagnostic or prognostic value. Timepoint: 6 months

Countries

India

Contacts

Public ContactRamesh R

Saveetha dental college

rameshr.sdc@saveetha.com9895725236

Outcome results

None listed

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