RANDOMIZED CLINICAL TRIAL ON CARIES ARREST USING SILVER DIAMINE FLUORIDE AND FLUORIDE VARNISH

Phase 2

Recruiting

• Conditions: enamel or dentin active caries (ICDAS 3- 6); silver diamine fluoride; caries arrest; children

• Registration Number: TCTR20180624001
• Lead Sponsor: /A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-24
• Study Completion: 2020-01-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

- Children aged 1-3 years
- Patients who have caries at least one surface enamel or dentin active caries (ICDAS 3-6)
- Voluntary under the written consent of parents or caregivers
- Children who have no major systemic diseases or on long term medication
- Children who have no allergy to fluoride or silver agent or Colophony agents which is ingredient in plaster or other dental materials
- Children with the family who have not planned to move to the other district within 2 years
- Parents can communicate in Thai language

Exclusion Criteria

- Children who having just only enamel caries (ICDAS 1-3)
- Tooth with a caries lesion extending into pulpal tissue or having any signs of irreversible pulpitis or non-vital tooth

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Caries arrest (arrest/not arrest) 6,12,18 months tactile sensation when drawing the probe across the lesion

Secondary Outcome Measures

Name	Time	Method
/A N/A N/A