Dental Caries, Dental Caries in Children
Conditions
Brief summary
The objective of this randomized clinical study is to evaluate the survival of repairs in restorations using composite resin (CR) or high viscosity glass ionomer cement (GIC) in primary molars. This trial is nested to another study (NCT03520309), so patients will be enrolled from CARDEC 3. 312 restorations will be included and randomized into two groups: glass ionomer cement (Riva Self Cure, SDI, Australia) and composite resin (Filtek Bulk Fill and Filtek Bulk Fill Flow, 3M ESPE, USA). After the end of treatments, patients will be followed for 24 months to assess the success of the restorations, which will be considered as the absence of the need for reintervention. The Kaplan-Meier survival curves and the log-rank tests will be performed to assess survival between groups and Cox regression analysis will be used to compare the outcome with the variables (α = 5%).
Detailed description
Failed restorations in primary teeth will be repaired using GIC or composite resin.
Interventions
PROCEDUREEncapsulated Glass Ionomer Cement
Repair of restorations in primary molars using Encapsulated High Viscosity Glass Ionomer (RIVA Self Cure - SDI). No local anesthesia will be used. A portion of the former restoration and infected carious tissue can be removed if necessary, and then the restoration will be repaired with GIC (Glass Ionomer Cement).
PROCEDUREComposite resin
Repair of restorations in primary molars using composite resin (Filtek Bulk Fill- 3M ESPE.) No local anesthesia will be used.A portion of the former restoration and infected carious tissue can be removed if necessary, and then the restoration will be repaired with CR (composite resin).
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* Children who have sought treatment in the School of Dentistry, University of Sao Paulo * Children between 3 and 10 years old * Children presenting at least one restoration (of any material, any surface and any integrity status) in primary teeth
Exclusion criteria
* Children whose parents did not agree to participate in the study * Children with behavioural issues at the initial exam or who did not assent to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical success of restorations after repair | 24 months | Visual assessment using Frencken criteria for occlusal restoration and Roeleveld et al. criteria for occlusoproximal restorations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost- effectiveness of restorations repairs | 24 months | To assess this outcome measure we will consider the percentage of patients needing new operatory interventions and costs will be assessed in monetary units (US dollars) |
| Patient's discomfort | baseline | Wong-Baker facial scale - from 0 to 5 (immediately after treatment) |
Countries
Brazil
Contacts
Primary ContactDaniela P Raggio
Outcome results
None listed