Clinical trial NCT06786975: Effectiveness and Acceptability of SDF Compared to ART for the Management of Early Childhood Caries
Official title: Effectiveness and Acceptability of Silver Diamine Fluoride for the Management of Early Childhood Caries at the Community Level Compared to Atraumatic Restorative Treatment, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Early Childhood Caries
Health Care Acceptability
Keywords: Early Childhood Caries
Silver Diamine Fluoride
Atraumatic Restorative Treatment
Lead sponsor: Universidad de La Frontera
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 100
Sex: ALL
Minimum age (years): 24
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be an open multicenter superiority single-blinded randomized clinical trial (RCT) with parallels groups.

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: 74 participants (children) for silver diamine fluoride application.
* Control: 74 participants (children) for atraumatic restorative treatment technique.

It's expected to have at least 224 teeth with caries lesions per group and 448 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).

Only the outcomes assessor will be masked.
Primary purpose: TREATMENT

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).

Researchers will compare the SDF's groups and the ART's group to see which of them is more accepted and effective at community level.

Main outcome: parents and children acceptability to SDF and ART.

Detailed description: A randomized clinical trial (RCT) with parallels groups will be conducted on children from chilean public kindergarten and schools from 2 years up to 4 years and 11 months.

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 at the community level. 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).

N° Participants (anticipated): 221 teeth with caries lesions per group, assuming an average of 3 teeth with caries lesions per child, it's expected to treat 148 children (from 2 years up to 4 years and 11 months), with 74 children per group.

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

Primary outcomes:
measure: Arrest of the carious lesion:
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Absence of pulp pathology
timeFrame: 6 and 12 months
measure: Presence of the tooth in the mouth.
timeFrame: 6 and 12 months
measure: Change in oral health-related quality of life
timeFrame: baseline and 6 months
measure: Parental acceptability: quantitative measure
timeFrame: 1 month, 6 months, and 12 months
measure: Parental acceptability: qualitative measure
timeFrame: 1 month
measure: Children's acceptability
timeFrame: at the end of the initial treatment, 6 and 12 months.
measure: Presence of adverse effects
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Temuco
country: Chile
facility: Universidad de La Frontera
state: La Araucanía
Study officials:
affiliation: Universidad de La Frontera
name: Patricia Muñoz, Master
role: STUDY_DIRECTOR
affiliation: Universidad de La Frontera
name: Patricia Pineda, Master
role: STUDY_CHAIR
affiliation: Universidad de La Frontera
name: Carlos Zaror, Doctor
role: STUDY_CHAIR
References: