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A study to compare two methods of single and two-visit restorative treatment in back milk teeth using silver diamine fluoride

A randomized controlled trial to evaluate the success of single versus two - visit protocols of Silver modified atraumatic restorative treatment (SMART) in primary molars

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/04/051932
Enrollment
150
Registered
2023-04-24
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

Health Condition 1: K02- Dental caries

Interventions

Intervention1: two visit Silver modified atraumatic restorative treatment ( SMART): Silver diamine fluoride or SDF will be applied to the included carious tooth on first visit to allow caries arrest a

Sponsors

Nidhi Sharawat
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Apparently healthy children in the age group 4 to 9 years Asymptomatic dentinal cavitated lesions accessible to hand instrumentation in at least one primary molar Children with frankl behavior rating scale positive or definitely positive Children whose parents have consented to take part in the study and whose parents accept to report for the scheduled follow up. RADIOGRAPHIC CRITERIA Carious lesions involving the outer 3rd and middle third of dentin

Exclusion criteria

Exclusion criteria: Teeth with signs of pulpal and periapical pathology such as having an abscess fistula sinus or spontaneous pain Children with developmental defects or hypoplasia in relation to the selected tooth Physiologic tooth mobility due to root resorption Children with known allergy to silver Children with designated molars having more than two surfaces involved with caries

Design outcomes

Primary

MeasureTime frame
To evaluate and compare the success of GIC restoration in primary molars using two SMART protocols i.e. one visit SMART and two visit SMART technique.Timepoint: 6 months and 12 months

Secondary

MeasureTime frame
number of minor failures in terms of partial loss of restoration without the need of re-restoration and number of major failures in terms of complete loss of restoration and requirement of endodontic treatment or extraction of toothTimepoint: 6 months and 12 months after the restoration

Countries

India

Contacts

Public ContactNidhi Sharawat

Centre for Dental Education and Research AIIMS New Delhi

drkalpanabansal@gmail.com9810105132

Outcome results

None listed

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