Dental Caries Tooth Diseases
Conditions
Interventions
This is a two-arm randomized controlled clinical trial conducted with children aged 6 to 11 years, of both sexes, enrolled in public elementary schools participating in the School Health Program in th
however, the study will not follow a split-mouth design. Eligible teeth will be randomly allocated into two groups: the experimental group, in which restorations will be performed using the Atraumatic
Sponsors
Faculdade de Odontologia de Piracicaba da Universidade de Campinas - FOP/UNICAMP
Faculdade de Odontologia de Piracicaba da Universidade de Campinas - FOP/UNICAMP
Eligibility
Age
6 Years to 11 Years
Inclusion criteria
Inclusion criteria: Schoolchildren of both sexes; aged between 6 and 11 years; enrolled in the aforementioned schools in Piracicaba; who are in the first transitional period of mixed dentition; presenting deciduous teeth with active caries lesions in cavitated dentin, in moderate or advanced stages, located on occlusal or occluso-proximal surfaces of the first or second deciduous molars, in any quadrant of the dental arch; provided they are accessible to the manual instruments used in the Atraumatic Restorative Treatment technique
Exclusion criteria
Exclusion criteria: Lesions that have progressed to chronicity; Black's class II dental lesion with proximal expulsive box; lesions inaccessible with manual instruments; lesions with total loss of one or more cusps; loss of the entire inner slope of the working cusp or lesions with pulpal involvement; presence of pain; abscess; fistulas and gingival/pulpal polyps and extensive coronal destruction; previously treated teeth; exfoliated teeth; lost teeth
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study expects to find higher survival rates for ART restorations performed with the encapsulated hybrid glass ionomer Equia Forte in primary teeth with active cavitated dentin caries, as verified by clinical assessment according to ART criteria and the identification of restorative failures over a 24-month period | — |
Secondary
| Measure | Time frame |
|---|---|
| The study expects to find an improvement in the impact of oral health on the quality of life of children and their families, as measured by the Early Childhood Oral Health Impact Scale (ECOHIS), based on a comparison of pre- and post-intervention scores over a 24-month follow-up period | — |
Countries
BR
Contacts
Public ContactKarine Mendes
Faculdade de Odontologia de Piracicaba da Universidade de Campinas - FOP/UNICAMP
Outcome results
None listed