Dental Caries in ChildrenNCT03063307
Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries
A study testing Atraumatic Restorative Treatment and Silver Diamine Fluoride in people with Dental Caries in Children, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial summary
The present study aims to evaluate, through a controlled clinical randomized study,the effectiveness of silver diamine fluoride in arresting dentin caries lesions in primary molars when compared to atraumatic restorative treatment. Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- Atraumatic Restorative Treatment and Silver Diamine Fluoride
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Sep 2016to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- CHILDREN
- aged 2 to 5 years;
- who are in good general health;
- have at least one active dentin carious lesion on the occlusal surface of primary molars corresponding to ICDAS codes 5 or 6.
Who cannot join
- CHILDREN
- with systemic or neurological diseases;
- whose families intend to move from Rio de Janeiro next year;
- with a history of allergy to silver or any substance present in the different materials to be used for treatment.
- TEETH
- with spontaneous or provoked pain, dental mobility or radiographic signs of involvement or possible pulp involvement;
- shows possible pulp involvement by radiographic examination
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Departamento de Odontopediatria e Ortodontia da UFRJ
Rio de Janeiro, 21941-913
About this study
Official title: Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries in Deciduous Molars: a Controlled and Randomized Clinical Trial
The present study aims to evaluate, through a controlled clinical randomized study,the effectiveness of silver diamine fluoride in arresting dentin caries lesions in primary molars when compared to atraumatic restorative treatment.
Read the detailed description
The present controlled clinical randomized study aiming at evaluating the effectiveness of silver diamine fluoride (SDF) in arresting dentin caries lesions on the occlusal surface of primary molars when compared to atraumatic restorative treatment (ART). For this, 118 healthy children aged 2-5 years with at least one active dentin carious lesion, with no signs of pain or pulp involvement. The participants will be allocated randomly to one of two treatment groups: (1) Test Group - SDF and (2) Control Group - ART. The International Caries Detection and Assessment System (ICDAS) will be used to determine caries diagnosis and activity. In both groups, the guardians and children will receive oral hygiene instructions and will be advised about eating habits and fluoride dentifrice use.The clinical success will be verified through examinations performed by a blinded operator, after 3, 6 and 12 months, with clinical evaluations to detect caries arresting, representing the primary outcome of the study.
- Conditions
- Dental Caries in Children
- Being tested
- Atraumatic Restorative Treatment, Silver Diamine Fluoride
- Keywords
- Tooth, Deciduous, Dental Caries, Glass Ionomer Cements, Dental Atraumatic Restorative Treatment, Cariostatic Agents, Fluorides
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atraumatic Restorative TreatmentProcedure or surgery
Also called ART, Glass Ionomer Cements, Ketac Molar Easymix
Silver Diamine FluorideOther
Also called SDF, SDF 30%, Cariostop 30% Biodinâmica
| Study group | Role | What they receive |
|---|---|---|
| Atraumatic Restorative Treatment | Active comparator | Not described Receives: Procedure: Atraumatic Restorative Treatment |
| Silver Diamine Fluoride | Experimental | Not described Receives: Other: Silver Diamine Fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries arresting
The main outcome of the study will be the observation of the proportion of arrested caries lesions in the test group, compared to the control group.
Measured: The follow-up oral examinations will be conducted every 3 months for 48 months totally
Secondary outcomes (5)
Duration of the intervention visit
Time (in minutes) spent on each type of intervention (DFP x ART)
Measured: 1 year
Cost
The cost of each treatment will be recorded and compared to each other
Measured: 1 year
Aesthetic perception and treatment satisfaction
Information on aesthetic perception will be obtained through a questionnaire, addressed to parents / guardians.
Measured: First appointment, 3,6 and 12 months after treatment.
Anxiety
A facial imaging scale will be used to assess the degree of anxiety of children 3 years of age or older. before and after first exam and treatment appointments.
Measured: From allocation up to two weeks.
Quality of life assessment
Information about quality of life will be obtained through the questionnaire Brazilian Early Childhood Oral Health Impact Scale (B-ECOHIS), addressed to parents / guardians.
Measured: First appointment,15 days and 3 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start20 Sep 2016
- Primary completion31 Dec 2018
- Study completion31 Dec 2020
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 Dental Caries in ChildrenStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Collaborators
- Rio de Janeiro State University
- Responsible party
- Principal investigator, Ana Lúcia Vollú, Universidade Federal do Rio de Janeiro
- Investigators
- Ana Lucia Vollu, MSD Student, Principal investigator, Universidade Federal Fluminense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063307
- Sponsor's protocol ID
- silverdiamine
- Status last verified
- Mar 2021
- First submitted
- 15 Feb 2017
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Rodrigues GF, Vollu AL, Vargas TR, Kamp LMK, da Cunha Costa T, Cruz LR, Luiz RR, Barja-Fidalgo F, Fonseca-Goncalves A. Efficacy of 30% silver diamine fluoride compared to atraumatic restorative treatment in arresting dentin caries lesions in preschoolers: a randomized clinical trial. Clin Oral Investig. 2024 Dec 6;29(1):3. doi: 10.1007/s00784-024-06081-8.
PubMed 39641816
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries in Deciduous Molars: a Controlled and Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03063307
- Acronym / sponsor ID
- silverdiamine
- Conditions
- Dental Caries in Children
- Keywords
- Tooth, Deciduous, Dental Caries, Glass Ionomer Cements, Dental Atraumatic Restorative Treatment, Cariostatic Agents, Fluorides
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Collaborators
- Rio de Janeiro State University
- Study start
- 20 Sep 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 24 Feb 2017 (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 present study aims to evaluate, through a controlled clinical randomized study,the effectiveness of silver diamine fluoride in arresting dentin caries lesions in primary molars when compared to atraumatic restorative treatment.
Detailed description
The present controlled clinical randomized study aiming at evaluating the effectiveness of silver diamine fluoride (SDF) in arresting dentin caries lesions on the occlusal surface of primary molars when compared to atraumatic restorative treatment (ART). For this, 118 healthy children aged 2-5 years with at least one active dentin carious lesion, with no signs of pain or pulp involvement. The participants will be allocated randomly to one of two treatment groups: (1) Test Group - SDF and (2) Control Group - ART. The International Caries Detection and Assessment System (ICDAS) will be used to determine caries diagnosis and activity. In both groups, the guardians and children will receive oral hygiene instructions and will be advised about eating habits and fluoride dentifrice use.The clinical success will be verified through examinations performed by a blinded operator, after 3, 6 and 12 months, with clinical evaluations to detect caries arresting, representing the primary outcome of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atraumatic Restorative Treatment | Active comparator | Procedure: Atraumatic Restorative Treatment |
| Silver Diamine Fluoride | Experimental | Other: Silver Diamine Fluoride |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- CHILDREN
Key exclusion criteria (7 listed)
- CHILDREN
- TEETH
- with spontaneous or provoked pain, dental mobility or radiographic signs of involvement or possible pulp involvement;
- shows possible pulp involvement by radiographic examination
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 |
|---|---|---|
| Atraumatic Restorative TreatmentAlso: ART, Glass Ionomer Cements, Ketac Molar Easymix | Procedure or surgery | Atraumatic Restorative Treatment |
| Silver Diamine FluorideAlso: SDF, SDF 30%, Cariostop 30% Biodinâmica | Other | Silver Diamine Fluoride |
Primary outcome
Caries arresting
Time frame: The follow-up oral examinations will be conducted every 3 months for 48 months totally
The main outcome of the study will be the observation of the proportion of arrested caries lesions in the test group, compared to the control group.
5 secondary outcomes
Duration of the intervention visit
Time frame: 1 year
Cost
Time frame: 1 year
Aesthetic perception and treatment satisfaction
Time frame: First appointment, 3,6 and 12 months after treatment.
Anxiety
Time frame: From allocation up to two weeks.
Quality of life assessment
Time frame: First appointment,15 days and 3 months after treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Derived from this study: PubMed 39641816Rodrigues GF, Vollu AL, Vargas TR, Kamp LMK, da Cunha Costa T, Cruz LR, Luiz RR, Barja-Fidalgo F, Fonseca-Goncalves A. Efficacy of 30% silver diamine fluoride compared to atraumatic restorative treatment in arresting dentin caries lesions in preschoolers: a randomized clinical trial. Clin Oral Investig. 2024 Dec 6;29(1):3. doi: 10.1007/s00784-024-06081-8.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ana Lucia Vollu, MSD Student principal investigator
Universidade Federal Fluminense
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atraumatic Restorative Treatment and Silver Diamine Fluoride in people with Dental Caries in Children, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 4 Mar 2021. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caries arresting (time frame: The follow-up oral examinations will be conducted every 3 months for 48 months totally). 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 NCT03063307, 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 4 Mar 2021.