Early Childhood CariesSDF and ARTNCT06786975
Effectiveness and Acceptability of SDF Compared to ART for the Management of Early Childhood Caries
A study testing Silver Diamine Fluoride and Atraumatic Restorative Treatment in people with Early Childhood Caries and Health Care Acceptability, run by Universidad de La Frontera at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 71 months
- Conditions the study is for
- Early Childhood Caries, Health Care Acceptability
- What is being tested?
- Silver Diamine Fluoride and Atraumatic Restorative Treatment
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteChile
- Study dates
- 15 Dec 2025to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 71 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site
Universidad de La Frontera
Temuco, La Araucanía, 4811230
Patricia Muñoz, Master, 56452325775, patricia.munoz@ufrontera.cl
About this study
Official title: EFFECTIVENESS, ACCEPTABILITY AND ORAL HEALTH-RELATED QUALITY OF LIFE OF SILVER DIAMINE FLUORIDE COMPARED TO ATRAUMATIC RESTORATIVE TREATMENT FOR THE MANAGEMENT OF EARLY CHILDHOOD CARIES: PROTOCOL OF A PRAGMATIC RANDOMIZED CLINICAL TRIAL
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?
Read more
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.
Read the 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
- Being tested
- Silver Diamine Fluoride, Atraumatic Restorative Treatment
- Keywords
- Early Childhood Caries, Silver Diamine Fluoride, Atraumatic Restorative Treatment
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver Diamine FluorideDevice
Also called Silver dental arrest, Diammine silver fluoride dental hypersensitivity varnish
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 TreatmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Atraumatic Restorative Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)]
Measured: 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).
Measured: 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.
Measured: 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]
Measured: 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.
Measured: baseline and 6 months
Secondary outcomes (3)
Absence of pulp pathology
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.]
Measured: 6 and 12 months
Presence of the tooth in the mouth.
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.
Measured: 6 and 12 months
Presence of adverse effects
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.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start15 Dec 2025 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early Childhood CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de La Frontera
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Muñoz Millán, Universidad de La Frontera
- Investigators
- Patricia Muñoz, Master, Study director, Universidad de La FronteraPatricia Pineda, Master, Study chair, Universidad de La FronteraCarlos Zaror, Doctor, Study chair, Universidad de La Frontera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786975
- Sponsor's protocol ID
- DI19-0091
- Acronym
- SDF and ART
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2024
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing plan: Study Protocol, Statistical Analysis Plan, Informed Consent Form will be available in the published protocol. The final, anonymized individual participant data (including the statistical code) that underlie the results will be available upon reasonable request. Data sharing will commence after the publication of the primary results and remain accessible for a minimum of five years. 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. Shared data will strictly exclude any direct or indirect identifiers. All researchers using the data must agree to acknowledge the original researchers and the trial's funding source.
Publications
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.
PubMed 41688106
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTIVENESS, ACCEPTABILITY AND ORAL HEALTH-RELATED QUALITY OF LIFE OF SILVER DIAMINE FLUORIDE COMPARED TO ATRAUMATIC RESTORATIVE TREATMENT FOR THE MANAGEMENT OF EARLY CHILDHOOD CARIES: PROTOCOL OF A PRAGMATIC RANDOMIZED CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT06786975
- Acronym / sponsor ID
- SDF and ART / DI19-0091
- Conditions
- Early Childhood Caries, Health Care Acceptability
- Keywords
- Early Childhood Caries, Silver Diamine Fluoride, Atraumatic Restorative Treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Universidad de La FronteraUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Silver Diamine Fluoride | Experimental | Device: Silver Diamine FluorideParticipants 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. |
| Atraumatic Restorative Treatment | Active comparator | Procedure: Atraumatic Restorative TreatmentParticipants 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. |
Who may qualify
- Ages
- 24 to 71 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silver Diamine FluorideAlso: Silver dental arrest, Diammine silver fluoride dental hypersensitivity varnishTooth 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. | Device | Silver Diamine Fluoride |
| Atraumatic Restorative TreatmentParticipants 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. | Procedure or surgery | Atraumatic Restorative Treatment |
Primary outcome
Arrest of the carious lesion:
Time frame: 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)]
Parental acceptability: quantitative measure
Time frame: 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).
Parental acceptability: qualitative measure
Time frame: 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.
Children's acceptability
Time frame: 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]
Change in oral health-related quality of life (OHRQoL)
Time frame: baseline and 6 months
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.
3 secondary outcomes
Absence of pulp pathology
Time frame: 6 and 12 months
Presence of the tooth in the mouth.
Time frame: 6 and 12 months
Presence of adverse effects
Time frame: 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Derived from this study: PubMed 41688106Munoz 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.
- Individual participant dataSharing planned: Yes. Data sharing plan: Study Protocol, Statistical Analysis Plan, Informed Consent Form will be available in the published protocol. The final, anonymized individual participant data (including the statistical code) that underlie the results will be available upon reasonable request. Data sharing will commence after the publication of the primary results and remain accessible for a minimum of five years. 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. Shared data will strictly exclude any direct or indirect identifiers. All researchers using the data must agree to acknowledge the original researchers and the trial's funding source.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patricia Muñoz, Master study director
Universidad de La Frontera
Patricia Pineda, Master study chair
Universidad de La Frontera
Carlos Zaror, Doctor study chair
Universidad de La Frontera
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silver Diamine Fluoride and Atraumatic Restorative Treatment in people with Early Childhood Caries and Health Care Acceptability, run by Universidad de La Frontera at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patricia Muñoz, Master (56452325775, patricia.munoz@ufrontera.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arrest of the carious lesion: (time frame: 6 and 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06786975, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025; AzTrials last refreshed its copy on 1 Nov 2026.