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A clinical trial to compare the effect of two treatment methods for restoring primary molar.

Comparative evaluation of clinical success on restoring untreated and 38% SDF treated dentine caries lesions in primary molars with the ART approach : A split mouth clinical trial study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050781
Enrollment
46
Registered
2023-03-17
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

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: ART with 38% Silver Diamine Fluoride: A split mouth study design will be adopted with 46 participants, who will receive 38% Silver Diamine Fluoride in the first appointment followed by

Sponsors

DR. ADITYA S NAIK
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All healthy children aged between 4-8 years, of both sexes. Requiring restorations of bilateral primary molars. Asymptomatic primary molars with active caries. ICDAS II Score 5 Cooperative children with Frankel behavior rating scale (FBRS) score of 3 or 4 All participants agreeing to the written informed consent and willing for the same.

Exclusion criteria

Exclusion criteria: Children who suffered from serious systemic disease/conditions Tooth with pulpal involvement/pathology as evident by clinical and radiographic examination. Caries lesions which were too small for hand instruments to prepare the cavity for a restoration. Primary molars near exfoliation.

Design outcomes

Primary

MeasureTime frame
Clinical success of modified ART with 38% SDF in comparison to ART.Timepoint: Clinical evaluation of the restorations at placement, 6 months and 12 months.

Secondary

MeasureTime frame
Radiographic success and absence of secondary caries.Timepoint: Radiographic evaluation before placement and after 12 months

Countries

India

Contacts

Public ContactDR SULAKSHANA

GOVERNMENT DENTAL COLLEGE AND RESEARCH INSTITUTE

srinath.krishnappa@yahoo.com9845592166

Outcome results

None listed

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