NCT06786975

Effectiveness and Acceptability of SDF Compared to ART for the Management of Early Childhood Caries

EFFECTIVENESS, ACCEPTABILITY AND ORAL HEALTH-RELATED QUALITY OF LIFE OF SILVER DIAMINE FLUORIDE COMPARED TO ATRAUMATIC RESTORATIVE TREATMENT FOR THE MANAGEMENT OF EARLY CHILDHOOD CARIES: PROTOCOL OF A PRAGMATIC RANDOMIZED CLINICAL TRIAL

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: Universidad de La Frontera · Academic / Other
• Sex: All
• Age: 24 Months – 71 Months
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to assess the acceptability and clinical effectiveness of Silver Diamine Fluoride (SDF) in comparison with Atraumatic Restorative Treatment (ART) in Early Childhood Caries (ECC) management at the community level. The main question it aims to answer are: • It's SDF more accepted and effective than ART in early childhood caries management when implemented at the community level? Participants will be diagnosed by an experienced and calibrated dentist using the International Caries Detection and Assessment System (ICDAS), then children with decayed teeth will be treated with SDF (experimental) or ART (control); another operator will choose randomly the treatment for each participant. Furthermore, oral health education component will be given to children, parents and educators. Follow-up visits will be made at 6 and 12 months after child's treatment is complete. Before and after treatment parents will be asked to complete a child personal background survey (before), Early Childhood Oral Health Impact Scale (ECOHIS) questionnaire (before and at follow-ups) and a oral health satisfaction survey (one week after treatment and at follow-ups). The acceptability will be assessed through quantitative and qualitative methods. Researchers will compare the SDF's groups and the ART's group to see which of them is more accepted and effective.

Detailed description

An open-label parallel superiority randomized clinical trial (RCT) will be conducted involving children aged 2 to 5 years. The aim of this clinical trial is to assess the acceptability and clinical effectiveness of Silver Diamine Fluoride (SDF) in comparison with Atraumatic Restorative Treatment (ART) in Early Childhood Caries (ECC) management. As well, this clinical trial sought to compare the oral health quality of life related and to contrast possible adverse effects between both therapies. Participants will be screened and diagnosed by an experienced and calibrated dentist using the International Caries Detection and Assessment System (ICDAS), thereafter only children with decayed teeth (or tooth) will be treated. After the diagnostic participants eligibles will be randomly chosen by another operator to be treated with SDF or ART for all teeth who need treatment in the child: * Experimental: SDF application in decayed teeth and oral health education component. * Control: ART technique in decayed teeth and oral health education component. The oral health education component will be given to children, parents and educators. The eligible children parents will be asked to fulfill a children personal background survey (before treatment), the Early childhood oral health impact scale (ECOHIS) questionnaire (before and after treatment at follow-ups) and a oral health satisfaction survey (a week after treatment and at follow-ups). The acceptability will be assessed through quantitative and qualitative methods. A sample is: 234 teeth with carious lesions per group is estimated. Estimating an average of three teeth with carious lesions per child, 78 children are necessary per group.

Conditions

• Early Childhood Caries
• Health Care Acceptability

Interventions

Type	Name	Description
DEVICE	Silver Diamine Fluoride	Tooth will be isolated with cotton rolls, the oral cavity will be dried with small cotton balls and the gingiva around the tooth, and surrounding structures, will be protected with vaseline. Then the silver diamine fluoride solution will be applied to cavitated caries lesions with a micro applicator for one minute approximately. If necessary the solution excess should be removed with a gauze. Finally the child's teacher will be given the indications for the child to not eat, drink or rinse up to 30 minutes after the treatment, and to evaluate if any sign or symptom related to the tooth appears.
PROCEDURE	Atraumatic Restorative Treatment	Participants will be treated with Atraumatic Restorative Treatment (ART) technique. Glass ionomer will be used for cavity filling (Ketac MolarTM, 3M ESPETM) according to manufacter specifications and will be applied with a spatula, followed by finger pressure using vaseline for a few seconds; for occluso-proximal cavities, a matrix band will be used. The restoration will be protected with vaseline and then the occlusion will be checked with articular paper after the initial adjustment (approximately 5 minutes). Finally the child's teacher will be given the indications for the child to not eat, drink or rinse up to 30 minutes after the treatment, and to evaluate if any sign or symptom related to the tooth appears.

Timeline

• Start date: 2025-12-15
• Primary completion: 2026-02-28
• Completion: 2027-02-28
• First posted: 2025-01-22
• Last updated: 2025-12-12

Locations

1 site across 1 country: Chile