An observational study in Dental Caries in Children, sponsored by Universidad Mayor de San Simón. Completed at 1 site in Bolivia. Open to participants aged 4 Years to 12 Years. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Universidad Mayor de San Simón · Observational
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
1,171 studies on the registry are indexed under Dental Caries; 209 are open to participants now.
This study's enrollment of 199 is above the median of 174 across 187 observational studies indexed under Dental Caries.
Browse Dental Caries studies →Universidad Mayor de San Simón is the lead sponsor of 2 studies on the registry; none are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Combination Product: Silver diamine fluoride 38% followed by Sodium fluoride varnish 5%
Drug page: Silver diamine fluoride
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.
Also known as: CaviGuard®, Silver Diamine Fluoride (SDF)
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.
Time frame: 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.
Time frame: 12 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 12 months from treatment
Plan to share: No
Ran from Nov 2022 to primary completion in Nov 2023, 12 months.
Of 46 non-industry observational studies under Dental Caries, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 32. This study's 12 months is close to that.
Counting every sponsor, half of 47 studies reached it within 12 months; a quarter within 7 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Universidad Mayor de San Simón