Management of large carious lesions in primary teeth Oral Health Dental caries
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Cooperative healthy children 2. Vital primary molars with large carious lesions that could be restored with composite 3. No history of spontaneous pain, pathologic mobility, redness or swelling of the vestibule, draining sinus tracts, or sensitivity to vestibular palpation 4. Absence of internal or external root resorption or inter-radicular/apical radiolucency 5. Both children and their parents had to be able to attend a 6-month follow-up procedure
Exclusion criteria
Exclusion criteria: Any clinical or radiographic signs indicating non-vital teeth
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility, estimated using the following measurements: 1. Proportion of eligible children among those examined, calculated after completion of the assigned number of participants 2. Proportion of children who completed the 6-month follow-up among those randomized, calculated after completion of the assigned period | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rates of the materials, which will be used to calculate the sample size for the definitive randomized controlled trial. Criteria used: absence/presence of clinical and radiographic signs, proportions calculated using simple formulas. Measured at the end of the treatment session as a baseline; the participants were clinically evaluated at 3 and 6 months post-treatment and evaluated radiographically after 6 months | — |
Countries
Syria