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

Official title

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

Overview

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.

Interventions

• 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 t
• 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 (approxima

Primary outcome measures

• Arrest of the carious lesion: [Time frame: 6 and 12 months]
• Parental acceptability: quantitative measure [Time frame: 1 month, 6 months, and 12 months]
• Parental acceptability: qualitative measure [Time frame: 1 month]
• Children's acceptability [Time frame: at the end of the initial treatment, 6 and 12 months.]
• Change in oral health-related quality of life (OHRQoL) [Time frame: baseline and 6 months]

Secondary outcome measures (3)

• Absence of pulp pathology [Time frame: 6 and 12 months]
• Presence of the tooth in the mouth. [Time frame: 6 and 12 months]
• Presence of adverse effects [Time frame: 6 and 12 months]

Eligibility criteria

Inclusion criteria

• Children belonging to INTEGRA or JUNJI kindergarten, from 2 years up to 5 years and 11 months with informed consent signed by parents and assent from the child.
• Children with at least one active cavitated caries lesion, extended in dentin with no signs of pulp involvement and diagnosed with ICDAS code 5.

Exclusion criteria

• Children with underlying systemic disease or disability
• Children with known allergies to dental materials used
• Children with transitory residence
• Children with severe alterations of the dental estructure

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Chile · 1 center

• Universidad de La Frontera — Temuco

Publications

• Munoz Millan P, Pineda P, Fontana M, Freyhofer VA, Ormeno A, Munoz K, Martinez-Zapata MJ, Zaror C. Effectiveness, acceptability and oral health-related quality of life of silver diamine fluoride compared with atraumatic restorative treatment for the management of early childhood caries: protocol of a pragmatic randomised clinical trial. BMJ Open. 2026 Feb 12;16(2):e106271. doi: 10.1136/bmjopen-202 PMID 41688106

Identifiers

NCT: NCT06786975 · DI19-0091

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗