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

NCT06786975 | Not Yet Recruiting DMC

• 1 other identifier: DI19-0091
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Childhood Caries; Health Care Acceptability

Keywords

Early Childhood Caries; Silver Diamine Fluoride; Atraumatic Restorative Treatment

Outcome Measures

Primary Outcomes (5)

• Arrest of the carious lesion:

  The activity and inactivity of the lesion shall be assessed. A value of 0 shall be recorded if the lesion is inactive and a value of 1 if the lesion is active. For the assessment of activity, the parameters described in the Caries Care Guide shall be considered. For the Fluoride Diamine Silver group, the lesion's surface should have a shiny appearance and hard consistency on examination to be considered inactive, when a soft, leathery and plaque retentive tissue is present, the lesion shall be considered active. For the Atraumatic Restorative Technique group, the Caries Associated to Restoration or Sealant (CARS)\* criteria will be applied, being considered inactive if the margin is intact (good margin) and upon presentation of a restoration or plaque retentive sealant requiring adjustment or replacement will be considered active. \[\*CARS includes 3 categories: good margin; defective (plaque-retentive, can be adapted); defective(needs replacement)\]

  6 and 12 months

• Parental acceptability: quantitative measure

  Parental acceptability will be measured through a survey at 1 month, 6 months, and 12 months post-treatment following by a own elaboration questionnare.The survey includes 6 questions. Whether they would recommend the treatment based on the results (aesthetics, absence of pain, arrest of lesion) and experience of the treatment received by their child (adaptation and access to care).

  1 month, 6 months, and 12 months

• Parental acceptability: qualitative measure

  A qualitative method will be used through semi-structured interviews to be conducted one month after the intervention.Parents with the lowest (10th percentile) and highest (90th percentile) acceptability (Parental acceptability: quantitative measure) will be selected. The semi-structured interview will explore their child's experience, what factors lead them to feel satisfied/dissatisfied with the treatment, factors that influenced their child's perceived comfort or discomfort during treatment, relevance of aesthetics, importance of the care setting to their satisfaction or dissatisfaction.

  1 month

• Children's acceptability

  Children's acceptability of treatment as assessed by the operator using Frankl´s scale at the end of the initial treatment, 6 and 12 months. The minimum value=1 and the maximum value is 4. The higher scores mean a worse children's acceptability. \[Frankl´s scale was used to evaluate child's behavior in the dental setting in four categories: 1-definitely negative 2-negative 3-positive 4- definitely positive\]

  at the end of the initial treatment, 6 and 12 months.

• Change in oral health-related quality of life (OHRQoL)

  Description: Change in oral health-related quality of life will be measured by the difference in the ECOHIS score between baseline and 6 months. The ECOHIS is a proxy-reported questionnaire for measuring the OHRQoL of preschool children and their families. It comprises of 13 items, covering six domains in two sections. The child's impacts section contains 4 domains. The family's impacts section contains 2 domains. Response categories for each question are rated on a 5-point Likert scale to record how often an event has occurred during the child's life: 0 = never, 1 = hardly ever, 2 = occasionally, 3 = often, 4 = very often, and 5 = don't know. ECOHIS scores are calculated as a simple sum of the response codes for the child and family sections separately and also a total score. The minimum value is 0 and maximum value is 52. Higher scores mean a worse quality of life.

  baseline and 6 months

Secondary Outcomes (3)

• Absence of pulp pathology

  6 and 12 months

• Presence of the tooth in the mouth.

  6 and 12 months

• Presence of adverse effects

  6 and 12 months

Study Arms (2)

Silver Diamine Fluoride

EXPERIMENTAL

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.

Device: Silver Diamine Fluoride

Atraumatic Restorative Treatment

ACTIVE COMPARATOR

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.

Procedure: Atraumatic Restorative Treatment

Interventions

Silver Diamine Fluoride 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.

Also known as: Silver dental arrest, Diammine silver fluoride dental hypersensitivity varnish

Silver Diamine Fluoride

Atraumatic Restorative Treatment 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.

Atraumatic Restorative Treatment

Eligibility Criteria

• Age: 24 Months - 71 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de La Frontera: lead

Study Sites (1)

Universidad de La Frontera

Temuco, La Araucanía, 4811230, Chile

Location

Related Publications (1)

• 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-2025-106271.

  PMID: 41688106 DERIVED

MeSH Terms

Conditions

Patient Acceptance of Health Care

Interventions

Dental Atraumatic Restorative Treatment

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

• Patricia Muñoz, Master

  Universidad de La Frontera

  STUDY DIRECTOR

• Patricia Pineda, Master

  Universidad de La Frontera

  STUDY CHAIR

• Carlos Zaror, Doctor

  Universidad de La Frontera

  STUDY CHAIR

Central Study Contacts

Patricia Muñoz, Master

CONTACT

56452325775; patricia.munoz@ufrontera.cl

Carlos Zaror, Doctor

CONTACT

56452325775; carlos.zaror@ufrontera.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Considering the treatment types, it is not possible to mask operators, examiners or participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Public Health Master, Specialist in Paediatric Dentistry, PhD exam passed at the Universidad Autónoma de Barcelona

Model Details: An open-label parallel superiority randomized clinical trial (RCT) Participants will be children with informed consent previously by their parents/guardians and assent given by the child. The participants will be randomized into two groups/arms with the permuted block randomization method, assuming an average of 3 teeth with caries lesions per child: * Experimental: 78 participants (children) for silver diamine fluoride application. * Control: 78 participants (children) for atraumatic restorative treatment technique. It's expected to have at least 234 teeth with caries lesions per group and 468 teeth with caries lesions in total. The child will be assigned as the unit of randomization, so all they teeth will be treated with the same intervention. Controls will be done up to 18 months after treatment (at 6, 12 and 18 months).

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: January 22, 2025
• Study Start: December 15, 2025
• Primary Completion: February 28, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Study protocol, statistical analysis plan, informed consent form will be available since February 2026. Analytic code will be available since January 2027
• Access Criteria: The Data sharing Proposals must be methodologically sound and sent to patricia.munoz@ufrontera.cl. Data users must formally sign a Data Access Agreement to ensure compliance with ethical guidelines and participant privacy.

Locations

CL (1)