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

Universidad de La Frontera

Status: Not yet enrolling

Conditions: Early Childhood Caries; Health Care Acceptability

Treatments: Device: Silver Diamine Fluoride; Procedure: Atraumatic Restorative Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06786975

DI19-0091

Details and patient eligibility

About

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.

Full 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.

Enrollment: 156 estimated patients

Sex: All

Ages: 24 to 71 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

156 participants in 2 patient groups

Silver Diamine Fluoride

Experimental group

Description:

Participants who will receive oral health education and Silver Diamine Fluoride application in decayed teeth every 6 month. Controls will be made up to eighteen months.

Treatment:

Device: Silver Diamine Fluoride

Atraumatic Restorative Treatment

Active Comparator group

Description:

Participants who will receive oral health education and atraumatic restorative treatment in decayed teeth. Controls will be made every 6 months up to eighteen months, in case of restoration failure it will be made again.

Treatment:

Procedure: Atraumatic Restorative Treatment