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

NCT ID: NCT06786975

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-15
• Study Completion Date: 2027-02-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Silver Diamine Fluoride

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.

Group Type: EXPERIMENTAL

Silver Diamine Fluoride

Intervention Type: DEVICE

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.

Atraumatic Restorative Treatment

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.

Group Type: ACTIVE_COMPARATOR

Atraumatic Restorative Treatment

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: PROCEDURE

Other Intervention Names

Silver dental arrest; Diammine silver fluoride dental hypersensitivity varnish

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

• Minimum Eligible Age: 24 Months
• Maximum Eligible Age: 71 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de La Frontera

OTHER

Sponsor Role: lead

Responsible Party

Patricia Muñoz Millán

Public Health Master, Specialist in Paediatric Dentistry, PhD exam passed at the Universidad Autónoma de Barcelona

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patricia Muñoz, Master

Role: STUDY_DIRECTOR

Universidad de La Frontera

Patricia Pineda, Master

Role: STUDY_CHAIR

Universidad de La Frontera

Carlos Zaror, Doctor

Role: STUDY_CHAIR

Universidad de La Frontera

Locations

Universidad de La Frontera

Temuco, La Araucanía, Chile

Countries

Chile

Central Contacts

Patricia Muñoz, Master

Role: CONTACT

patricia.munoz@ufrontera.cl

56452325775

Carlos Zaror, Doctor

Role: CONTACT

carlos.zaror@ufrontera.cl

56452325775

Facility Contacts

Patricia Muñoz, Master

Role: primary

patricia.munoz@ufrontera.cl

56452325775

Other Identifiers

DI19-0091

Identifier Type: -

Identifier Source: org_study_id