Health TrialsbyHealthPanel

Building Adaptive School-based Interventions for Caries

ConditionDental Caries
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age5-13
SponsorUniversity of Pennsylvania

About this trial

Dental caries (tooth decay) is the world's most prevalent noncommunicable disease. Current preventive and therapeutic treatments are available that can be provided in a school-based health service environment. However, not all children respond to care, and school programs can result in under- or over-treatment, leaving children at high risk. The Building Adaptive School-based Interventions for Caries (BASICS) study will identify the optimal sequence and intensity of these treatments to minimize nonresponse, creating adaptive interventions tailored to specific needs in order to personalize school-based dental medicine.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Be enrolled in participating schools

Be between the ages of 5 and 13 years

Provide parental/guardian informed consent

Child assent

Disqualifiers

Ulcerative gingivitis or stomatitis

Known sensitivity to silver or other heavy-metal ions

More than six affected sites

Those who have had full mouth gingivectomies

Trial design

Design model

Parallel

Treatments tested in this trial

  • Silver Diamine Fluoride (38%)

    Device

    Topically applied silver diamine fluoride 38% solution

  • Glass Ionomer Sealant

    Device

    GIC Dental Sealants

  • Fluoride Varnishes

    Device

    Topically applied fluoride varnish (FV)

  • Hygiene Intervention

    Behavioral

    Behavioral intervention to improve dental hygiene

Treatment groups

1,200 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Subgroup A, SDF onlyExperimental treatment 1 intervention
Group B: Subgroup D, Sealant onlyActive comparator 1 intervention
Group C: Subgroup B, SDF + FV + Hygiene InterventionExperimental treatment 3 interventions
Group D: Subgroup C, SDF + SMART + SealantExperimental treatment 2 interventions
Group E: Subgroup E, Sealant + SMART + FV + Hygiene InterventionExperimental treatment 3 interventions
Group F: Subgroup F, Sealant + SMARTExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Dental Caries Incidence

Number of teeth presenting with new caries

Time frame
Biannual assessment from enrollment to end of treatment (2.5 years)
2

Caries Prevalence

The prevalence of study participants with dental caries

Time frame
Biannual assessment from enrollment to end of treatment (2.5 years)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Source ClinicalTrials.gov
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