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

Not Applicable

Not yet recruiting

• Conditions: Early Childhood Caries; Health Care Acceptability

• Registration Number: NCT06786975
• Lead Sponsor: Universidad de La Frontera

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.

Study Timeline

• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2025-01-15
• Study First Posted: 2025-01-22
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-04
• Study Start: 2025-03-10
• Primary Completion: 2025-05-30
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Arrest of the carious lesion:	6 and 12 months	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.; \[\*CARS includes 3 categories: good margin; defective (plaque-retentive, can be adapted); defective(needs replacement)\]

Secondary Outcome Measures

Name	Time	Method
Absence of pulp pathology	6 and 12 months	Absence of pulp pathology: pufa=0 Measured with pufa index\* \[\*pufa= 1 o \>1 If presents p: pulpal involvement, opening of pulp chamber is visible or coronal tooth structures are destroyed by caries u: ulceration, traumatic ulceration in the soft tissues (tongue and mucosa), caused by tooth or root fragments f: a sinus tract releasing pus originating from an abscess and opening into the oral cavity a: abscess, dento-alveolar abscess.\]
Presence of the tooth in the mouth.	6 and 12 months	Presence of the tooth in the mouth. This refers to the fact that the tooth that was treated is still present in the mouth at the time of the control examination and has not been surgically extracted. It will be valued as 0 if it is present and as 1 if it has been extracted.
Change in oral health-related quality of life	baseline and 6 months	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.
Parental acceptability: qualitative measure	1 month	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.
Parental acceptability: quantitative measure	1 month, 6 months, and 12 months	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).
Children's acceptability	at the end of the initial treatment, 6 and 12 months.	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.; \[Frankl´s scale was used to evaluate child's behavior in the dental setting in four categories: 1-definitely negative 2-negative 3-positive 4- definitely positive\]
Presence of adverse effects	6 and 12 months	A questionnaire will be applied to the parents a week after treatment and also at 6 and 12 months follow-ups after treatment, where they'll have to report the presence of any adverse effect related to treatment.

Trial Locations

Locations (1)

Universidad de La Frontera; 🇨🇱 Temuco, La Araucanía, Chile