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Partial caries removal with and without SDF (caries arresting agent) and restoration in children

Comparison of success of partial excavation and RMGIC restoration with and without SDF application in primary molars in 3-6-year-old children: A randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030479
Enrollment
222
Registered
2021-01-14
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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: silver diamine flouride (SDF): The caries from the walls will be excavated using a sharp spoon excavator, leaving the soft dentinal caries on the floor intact. In the intervention group

Sponsors

Dr Harsh Sachdev
Lead Sponsor
Dr Amar Katre
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1.Primary molars with dentinal caries in otherwise healthy children. 2.Children whose parents give consent for the application of SDF.

Exclusion criteria

Exclusion criteria: 1.Tooth with history, clinical or radiographic signs indicative of pulpal and peri-radicular pathology. 2.Children suffering from any systemic condition that may hinder with their participation in the study. 3. Children with known allergy to any material used in the study. 4.Children who cannot co-operate while performing the procedure. 5.Children whose parents refuse to give consent for the study.

Design outcomes

Primary

MeasureTime frame
Survival of Restoration and Marginal Integrity of the Restoration.Timepoint: After the intervention survival of restoration will be checked at 1 month, 6 months, 12 months respectively. After the intervention Marginal Integrity of restoration will be checked at 1 month, 6 months, 12 months respectively.

Secondary

MeasureTime frame
Parents acceptance of application of silver diamine flourideTimepoint: After application of SDF parents acceptance of black staining for the silver diamine flouride

Countries

India

Contacts

Public ContactDr Harsh Sachdev

Y.M.T DENTAL COLLEGE AND HOSPITAL

amar_katre@hotmail.com9821540186

Outcome results

None listed

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