Dental Caries
Conditions
Brief summary
The objective of this randomized clinical trial is to evaluate the survival of restoration with high viscosity glass ionomer cement (HVGIC) with pre-etching with polyacrilic acid compared with no pre-etching in order to treat occlusoproximais caries lesion in primary molars, as well as the impact of those treatments in the caries lesion progression, the cost-efficacy of the procedures and the discomfort reported by the patient. Children of 4 to 8 years will be selected in the Pediatric Dentistry Clinic of Universidade Ibirapuera. 192 teeth will be randomized in 2 experimental groups: (1) HVGIC restoration with pre-etching and (2) HVGIC restoration with no pre-etching. Will be considered as primary outcome the survival of the restoration evaluated after 6, 12, and 24 months by two trained examiners. The carious lesions progression will be evaluated after 24 months of follow-up. The time of the treatments and the cost of the materials will be considered to estimate the cost-efficacy of each treatment. The discomfort reported by the participant will be measured after each procedure following the Wong-Baker scale. For the primary outcome, Kaplan-Meier survival and the Long-Rank test will be used in order to compare the two groups. Cox regression will be performed in order to evaluate thee influence of explanatory variables on the outcome.
Interventions
PROCEDUREHVGIC restoration with pre-etching
Pre-etching of the surface with polyacrylic acid for 10 s, followed by washing and drying the cavity with cotton balls; and fill with HVGIC, inserted into the cavity with the aid of an insertion spatula and adapted to the cavity by the digital pressure technique.
PROCEDUREHVGIC restoration with non pre-etching
Restoration with HVGIC, inserted into the cavity with the aid of an insertion spatula and adapted to the cavity by the digital pressure technique.
Sponsors
Universidade Ibirapuera
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Double-blind (Patient and Examiner) will not be able to blinding the operator due to the obvious difference between the techniques
Eligibility
Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients with carious lesion of occlusoproximais in primary molars
Exclusion criteria
* Patients will be excluded with special needs, using orthodontics devices and/or systemic diseases which may affect the oral cavity. * Also, teeth with pulp exposure, spontaneous pain, mobility, presence of abscess or fistula next to the tooth, teeth with restorations, sealants or enamel formation defects will also be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival of restorations | 24 months | Comparing the survival of HVGIC restorations without pre-etching with HVGIC restorations with pre-etching by clinical assessment using a criteria proposed by Roleveld et al., 2006. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caries lesion progression will be evaluated by comaparison of radiograph immediately after the restoration | Immediately after the restoration and 24 months | The caries lesion progression will be evaluated by comaparison of radiograph immediately after the restoration and after 24 months. |
| Cost-efficacy | 24 months. | The duration of the treatments (time of treatment) and the cost of the materials used will be considered for the estimation of the cost-efficacy of the treatments by a ratio - cost/efficacy, being efficacy considered the tooth survival. |
| Discomfort regarding the treatment options by a Wong-Baker FACES pain rating scale | Immediately after the treatment | Children-reported discomfort regarding the treatment options by a Wong-Baker FACES pain rating scale. The scale present 6 different faces since very happy until very sad with the treatment. |
Countries
Brazil
Outcome results
None listed