Dental Caries in ChildrenNCT05638217
Efficacy of the Use of Silver Diamine Fluoride and Sodium Fluoride Varnish for the Treatment of Caries in Children
An observational study of Dental Caries in Children, run by Universidad Mayor de San Simón at 1 site in Bolivia.
Trial summary
The goal of this observational study is to identify the efficacy of silver diamine fluoride 38% followed by sodium fluoride varnish 5% in a population with untreated dental caries age range 4 to 12 years old. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- Silver diamine fluoride 38% followed by Sodium fluoride varnish 5%
- How many people
- 199 participants
- Where
- 1 siteBolivia
- Study dates
- 7 Nov 2022to 15 Nov 2023
- Phase
- Observational
- 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: This study will be carried out in the city of Cochabamba, Bolivia, specifically at the Bolivian Food Bank Foundation located on Calle Francisco Prada between Aurelio Melean and J. Arauco 1120, from November 2022 to November 2023. This is a prospective cohort with a single assignment group (children aged 4 to 12 years) where a sample of 100-150 patients will be evaluated before, during and after their treatment.
Who may be able to join
- The patient must be able to receive all necessary treatments and may be followed up for additional treatments and/or record follow-ups at each time point and for the duration of the study.
- Children within the age range mentioned above.
- Require a completed informed consent form and completed nutritional survey record for anyone who will participate in the program.
- According to the evaluation of the dentist Caries grade I and grade II
- In the case of patients with disabilities, at least one parent or legal guardian must be present at all times during the study.
Who cannot join
- Patients who, after assessment, identify a pulp condition or abscess in any of the teeth, this affected piece will be excluded from receiving treatment with 38% silver diamine fluoride and 5% sodium fluoride varnish (in these cases, the Patient Coordinator will refer to a dentist outside the study for their treatment)
- Patients with caries with grade III or grade IV
- Patients with a known allergy to any of the active ingredients ( 38% silver diamine fluoride and 5% sodium fluoride varnish)
- Patients who were unable to give their informed consent or complete the nutritional survey.
- Patients who cannot participate during the entire program (12 months).
- Patients with other oral treatments (Orthodontics).
- Patients who are not present with at least one parent or legal guardian at the time of treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Cohort Study: Efficacy of the Use of 38% Silver Diamine Fluoride and 5% Sodium Fluoride Varnish in Patients 4 to 12 Years for the Treatment of Caries and Its Association With Other Aspects of Relevance
The goal of this observational study is to identify the efficacy of silver diamine fluoride 38% followed by sodium fluoride varnish 5% in a population with untreated dental caries age range 4 to 12 years old. The main questions to answer are
- Efficacy of treatment of active tooth decay with the treatment protocol of 38% silver diamine fluoride and 5% sodium fluoride varnish.
- Clinical evaluation of tooth decay treated with 38% silver diamine fluoride and 5% sodium fluoride varnish in quality of hardness, color change and caries progression.
- Explore the association of treatment with 38% silver diamine fluoride and 5% sodium fluoride varnish with: i. Reduction of oral pain caused by the presence of carious lesions. ii. Improvement in gingival oral health. iii. Changes in general nutritional status through measurements of height, weight, hemoglobin levels and nutritional survey. The participants will be identified, charted (with nutritional surveys and parameters), as well as treated and compared in a six- and twelve-month period, where researchers will clinically identify the association between the use of this protocol and the efficacy of such, as well as other related nutritional aspects.
- Conditions
- Dental Caries in Children
- Being tested
- Silver diamine fluoride 38% followed by Sodium fluoride varnish 5%
- Keywords
- Oral Health, Dental Caries, Silver Diamine Fluoride, Caries in Children, CaviGuard®
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver diamine fluoride 38% followed by Sodium fluoride varnish 5%Combination product
Also called CaviGuard®, Silver Diamine Fluoride (SDF)
1)Completely drying of the affected area 2)10 microliters of silver diamine fluoride 38% (CaviGuard®) will be placed on the affected area 3)The affected area should be immediately covered with 20 microliters of fluoride varnish 5% (CaviGuard®) 4)Repeat steps 1-3 one or two more times for large caries at intervals of at least 2 days apart 5)Follow up evaluation of treatment success visits will be conducted at 6 and 12 months from the initial treatment.
NOTE: This is a single intervention using the device registered as Caviguard® to apply both products (Silver diamine fluoride 38% followed by Sodium fluoride varnish 5% (®)) in sequence.
| Study group | Role | What they receive |
|---|---|---|
| Patients of 4 to 12 years old eligible to received dental cavity treatment | Patients of 4 to 12 years old that are eligible to received dental cavity treatment. The goal of this observational study is to identify the efficacy of silver diamine fluoride 38% followed by sodium fluoride varnish 5%, using "CaviGuard®" as delivery method, in a population with untreated dental caries age range 4 to 12 years old. Receives: Combination Product: Silver diamine fluoride 38% followed by Sodium fluoride varnish 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of arrested cavity lesions after treatment with 38% silver diamine fluoride and 5% sodium fluoride varnish
The investigators will evaluate the efficacy of treatment of active cavity lesions arrested after using the treatment protocol with 38% silver diamine fluoride and 5% sodium fluoride varnish. This evaluation will be performed by a trained dentist conducting an evaluation of multiple clinical findings including signs and symptoms of an active or arrested cavity.The clinical evaluation will be recorded in an odontograph for each patient.
Measured: 6 months from initial treatment
Ratio of arrested cavity lesions after treatment with 38% silver diamine fluoride and 5% sodium fluoride varnish
The investigators will evaluate the efficacy of treatment of active cavity lesions after using the treatment protocol with 38% silver diamine fluoride and 5% sodium fluoride varnish. This evaluation will be performed by a trained dentist conducting an evaluation of multiple clinical findings including signs and symptoms of an active or arrested cavity.The clinical evaluation will be recorded in an odontograph for each patient.
Measured: 12 months from treatment
Secondary outcomes (16)
Evaluate hardness
The investigators will evaluate the efficacy of treatment of active cavity lesions after using the treatment protocol with 38% silver diamine fluoride and 5% sodium fluoride varnish. This evaluation will be performed by a trained dentist, conducting an evaluation of clinical finding that include hardness. The clinical evaluation will be recorded in an odontograph for each patient and include dichotomous variables (yes/no) for the variable hardness.
Measured: 6 months from treatment
Evaluate color change
The investigators will evaluate the efficacy of treatment of active cavity lesions after using the treatment protocol with 38% silver diamine fluoride and 5% sodium fluoride varnish. This evaluation will be performed by a trained dentist, conducting an evaluation of clinical finding that include color change.The clinical evaluation will be recorded in an odontograph for each patient and include dichotomous variables (yes/no) for the variable color change.
Measured: 6 months from treatment
Evaluate cavity progression of cavity treated
The investigators will evaluate the efficacy of treatment of active cavity lesions after using the treatment protocol with 38% silver diamine fluoride and 5% sodium fluoride varnish. This evaluation will be performed by a trained dentist, conducting an evaluation of clinical finding that include cavity progression.The clinical evaluation will be recorded in an odontograph for each patient and include dichotomous variables (yes/no) for the variable cavity progression.
Measured: 6 months from treatment
Evaluation the reduction of oral pain caused by the presence of carious lesions.
The investigators will explore the association of treatment with 38% silver diamine fluoride and 5% sodium fluoride varnish with the reduction of oral pain caused by the presence of carious lesions. The clinical evaluation will be recorded in an odontograph for each patient and include dichotomous variables (yes/no) for the variable reduction of oral pain.
Measured: 6 months from treatment
Evaluate Improvement in gingival oral health.
The investigators will explore the association of treatment with 38% silver diamine fluoride and 5% sodium fluoride varnish with the Improvement in gingival oral health. The clinical evaluation will be recorded in an odontograph for each patient and include dichotomous variables (yes/no) for the variable gingival oral health.
Measured: 6 months from treatment
Evaluate changes in height and weight
The investigators will explore the association of treatment with 38% silver diamine fluoride and 5% sodium fluoride varnish with the patient nutritional status through measurements of height and weight that will be combined with height and weight for age in child grow standards from the world health organization.
Measured: 6 months from treatment
Evaluate changes in hemoglobin levels
The investigators will explore the association of treatment with 38% silver diamine fluoride and 5% sodium fluoride varnish with the patient nutritional status through measurements of hemoglobin levels recorded as (g/dl).
Measured: 6 months from treatment
Evaluate changes in a nutritional survey
The investigators will explore the association of treatment with 38% silver diamine fluoride and 5% sodium fluoride varnish with the patient nutritional status through a 59 question nutritional survey developed by the research team.
Measured: 6 months from treatment
Evaluate hardness
The investigators will evaluate the efficacy of treatment of active cavity lesions after using the treatment protocol with 38% silver diamine fluoride and 5% sodium fluoride varnish. This evaluation will be performed by a trained dentist, conducting an evaluation of clinical finding that include hardness. The clinical evaluation will be recorded in an odontograph for each patient and include dichotomous variables (yes/no) for the variable hardness.
Measured: 12 months from initial treatment
Evaluate color change
The investigators will evaluate the efficacy of treatment of active cavity lesions after using the treatment protocol with 38% silver diamine fluoride and 5% sodium fluoride varnish. This evaluation will be performed by a trained dentist, conducting an evaluation of clinical finding that include color change.The clinical evaluation will be recorded odontograph for each patient and include dichotomous variables (yes/no) for the variable color change.
Measured: 12 months from initial treatment
Evaluate cavity progression of cavity treated
The investigators will evaluate the efficacy of treatment of active cavity lesions after using the treatment protocol with 38% silver diamine fluoride and 5% sodium fluoride varnish. This evaluation will be performed by a trained dentist, conducting an evaluation of clinical finding that include cavity progression.The clinical evaluation will be recorded odontograph for each patient and include dichotomous variables (yes/no) for the variable cavity progression.
Measured: 12 months from initial treatment
Evaluation of the reduction of oral pain caused by the presence of carious lesions
The investigators will explore the association of treatment with 38% silver diamine fluoride and 5% sodium fluoride varnish with the reduction of oral pain caused by the presence of carious lesions. The clinical evaluation will be recorded in an odontograph for each patient and include dichotomous variables (yes/no) for the variable reduction of oral pain.
Measured: 12 months from initial treatment
Evaluate Improvement in gingival oral health.
The investigators will explore the association of treatment with 38% silver diamine fluoride and 5% sodium fluoride varnish with the Improvement in gingival oral health. The clinical evaluation will be recorded in an odontograph for each patient and include dichotomous variables (yes/no) for the variable gingival oral health.
Measured: 12 months from initial treatment
Evaluate changes in height and weight
The investigators will explore the association of treatment with 38% silver diamine fluoride and 5% sodium fluoride varnish with the patient nutritional status through measurements of height and weight that will be combined with height and weight for age in child grow standards from the world health organization.
Measured: 12 months from treatment
Evaluate changes in hemoglobin levels
The investigators will explore the association of treatment with 38% silver diamine fluoride and 5% sodium fluoride varnish with the patient nutritional status through measurements of hemoglobin levels recorded as (g/dl).
Measured: 12 months from treatment
Evaluate changes in a nutritional survey
The investigators will explore the association of treatment with 38% silver diamine fluoride and 5% sodium fluoride varnish with the patient nutritional status through a 59 question nutritional survey developed by the research team.
Measured: 12 months from treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start7 Nov 2022
- Primary completion15 Nov 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Mayor de San Simón
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Privada del Valle, Sede Cochabamba, Industria Química Farmacéutica SIGMA CORP S.R.L. Cochabamba, Bolivia, NODK LLC, Oregón, EE. UU., Food Bank Bolivia
- Responsible party
- Principal investigator, Rodrigo Arce Cardozo, Universidad Mayor de San Simón
- Investigators
- Nathaly Campero Ferrufino, DDS, Principal investigator, Private University of the ValleyXimena Claros Martinez, DDS, Principal investigator, Private University of the ValleyEdwin Guarayo Molina, DDS, Principal investigator, Private University of the ValleyRodrigo k Arce Cardozo, MD, MPH,, Principal investigator, Universidad Mayor de San SimonSteve Duffin, DDS, Principal investigator, NODK LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638217
- Sponsor's protocol ID
- DINV-CAV01-EC001
- Status last verified
- Nov 2023
- First submitted
- 10 Nov 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study: Efficacy of the Use of 38% Silver Diamine Fluoride and 5% Sodium Fluoride Varnish in Patients 4 to 12 Years for the Treatment of Caries and Its Association With Other Aspects of Relevance
- ClinicalTrials.gov ID
- NCT05638217
- Acronym / sponsor ID
- DINV-CAV01-EC001
- Conditions
- Dental Caries in Children
- Keywords
- Oral Health, Dental Caries, Silver Diamine Fluoride, Caries in Children, CaviGuard®
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Universidad Mayor de San SimónUniversity, hospital or other
- Collaborators
- Universidad Privada del Valle, Sede Cochabamba, Industria Química Farmacéutica SIGMA CORP S.R.L. Cochabamba, Bolivia, NODK LLC, Oregón, EE. UU., Food Bank Bolivia
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 6 Dec 2022 (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 observational study is to identify the efficacy of silver diamine fluoride 38% followed by sodium fluoride varnish 5% in a population with untreated dental caries age range 4 to 12 years old. The main questions to answer are
- Efficacy of treatment of active tooth decay with the treatment protocol of 38% silver diamine fluoride and 5% sodium fluoride varnish.
- Clinical evaluation of tooth decay treated with 38% silver diamine fluoride and 5% sodium fluoride varnish in quality of hardness, color change and caries progression.
- Explore the association of treatment with 38% silver diamine fluoride and 5% sodium fluoride varnish with: i. Reduction of oral pain caused by the presence of carious lesions. ii. Improvement in gingival oral health. iii. Changes in general nutritional status through measurements of height, weight, hemoglobin levels and nutritional survey. The participants will be identified, charted (with nutritional surveys and parameters), as well as treated and compared in a six- and twelve-month period, where researchers will clinically identify the association between the use of this protocol and the efficacy of such, as well as other related nutritional aspects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients of 4 to 12 years old eligible to received dental cavity treatment | – | Combination Product: Silver diamine fluoride 38% followed by Sodium fluoride varnish 5%Patients of 4 to 12 years old that are eligible to received dental cavity treatment. The goal of this observational study is to identify the efficacy of silver diamine fluoride 38% followed by sodium fluoride varnish 5%, using "CaviGuard®" as delivery method, in a population with untreated dental caries age range 4 to 12 years old. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study will be carried out in the city of Cochabamba, Bolivia, specifically at the Bolivian Food Bank Foundation located on Calle Francisco Prada between Aurelio Melean and J. Arauco 1120, from November 2022 to November 2023. This is a prospective cohort with a single assignment group (children aged 4 to 12 years) where a sample of 100-150 patients will be evaluated before, during and after their treatment.
Key inclusion criteria (5 listed)
- The patient must be able to receive all necessary treatments and may be followed up for additional treatments and/or record follow-ups at each time point and for the duration of the study.
- Children within the age range mentioned above.
- Require a completed informed consent form and completed nutritional survey record for anyone who will participate in the program.
- According to the evaluation of the dentist Caries grade I and grade II
- In the case of patients with disabilities, at least one parent or legal guardian must be present at all times during the study.
Key exclusion criteria (7 listed)
- Patients who, after assessment, identify a pulp condition or abscess in any of the teeth, this affected piece will be excluded from receiving treatment with 38% silver diamine fluoride and 5% sodium fluoride varnish (in these cases, the Patient Coordinator will refer to a dentist outside the study for their treatment)
- Patients with caries with grade III or grade IV
- Patients with a known allergy to any of the active ingredients ( 38% silver diamine fluoride and 5% sodium fluoride varnish)
- Patients who were unable to give their informed consent or complete the nutritional survey.
- Patients who cannot participate during the entire program (12 months).
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 fluoride 38% followed by Sodium fluoride varnish 5%Also: CaviGuard®, Silver Diamine Fluoride (SDF)1)Completely drying of the affected area 2)10 microliters of silver diamine fluoride 38% (CaviGuard®) will be placed on the affected area 3)The affected area should be immediately covered with 20 microliters of fluoride varnish 5% (CaviGuard®) 4)Repeat steps 1-3 one or two more times for large caries at intervals of at least 2 days apart 5)Follow up evaluation of treatment success visits will be conducted at 6 and 12 months from the initial treatment. NOTE: This is a single intervention using the device registered as Caviguard® to apply both products (Silver diamine fluoride 38% followed by Sodium fluoride varnish 5% (®)) in sequence. | Combination product | Patients of 4 to 12 years old eligible to received dental cavity treatment |
Primary outcome
Ratio of arrested cavity lesions after treatment with 38% silver diamine fluoride and 5% sodium fluoride varnish
Time frame: 6 months from initial treatment
The investigators will evaluate the efficacy of treatment of active cavity lesions arrested after using the treatment protocol with 38% silver diamine fluoride and 5% sodium fluoride varnish. This evaluation will be performed by a trained dentist conducting an evaluation of multiple clinical findings including signs and symptoms of an active or arrested cavity.The clinical evaluation will be recorded in an odontograph for each patient.
Ratio of arrested cavity lesions after treatment with 38% silver diamine fluoride and 5% sodium fluoride varnish
Time frame: 12 months from treatment
The investigators will evaluate the efficacy of treatment of active cavity lesions after using the treatment protocol with 38% silver diamine fluoride and 5% sodium fluoride varnish. This evaluation will be performed by a trained dentist conducting an evaluation of multiple clinical findings including signs and symptoms of an active or arrested cavity.The clinical evaluation will be recorded in an odontograph for each patient.
16 secondary outcomes
Evaluate hardness
Time frame: 6 months from treatment
Evaluate color change
Time frame: 6 months from treatment
Evaluate cavity progression of cavity treated
Time frame: 6 months from treatment
Evaluation the reduction of oral pain caused by the presence of carious lesions.
Time frame: 6 months from treatment
Evaluate Improvement in gingival oral health.
Time frame: 6 months from treatment
Evaluate changes in height and weight
Time frame: 6 months from treatment
Evaluate changes in hemoglobin levels
Time frame: 6 months from treatment
Evaluate changes in a nutritional survey
Time frame: 6 months from treatment
Evaluate hardness
Time frame: 12 months from initial treatment
Evaluate color change
Time frame: 12 months from initial treatment
Evaluate cavity progression of cavity treated
Time frame: 12 months from initial treatment
Evaluation of the reduction of oral pain caused by the presence of carious lesions
Time frame: 12 months from initial treatment
Evaluate Improvement in gingival oral health.
Time frame: 12 months from initial treatment
Evaluate changes in height and weight
Time frame: 12 months from treatment
Evaluate changes in hemoglobin levels
Time frame: 12 months from treatment
Evaluate changes in a nutritional survey
Time frame: 12 months from 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 18 Nov 2023.
- Description InterventionLink provided by the sponsor.
- Private University of the ValleyLink provided by the sponsor.
- 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.
Nathaly Campero Ferrufino, DDS principal investigator
Private University of the Valley
Ximena Claros Martinez, DDS principal investigator
Private University of the Valley
Edwin Guarayo Molina, DDS principal investigator
Private University of the Valley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries in Children, run by Universidad Mayor de San Simón at 1 site in Bolivia.
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 5 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 18 Nov 2023. 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 Bolivia. 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?
Ratio of arrested cavity lesions after treatment with 38% silver diamine fluoride and 5% sodium fluoride varnish (time frame: 6 months from initial treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2023.