Children with Disabilities
Conditions
Interventions
This is a randomized clinical study that is evaluating 58 children with cognitive impairment, diagnosed with mild to moderate learning deficit, aged between 4 and 10 years, who have caries lesions wit
and 50 teeth for the experimental group using teeth restored with the orthodontic bands technique cemented with conventional glass ionomers. The patients will be monitored through clinical and radiogr
Sponsors
Instituto e Centro de Pesquisas São Leopoldo Mandic
Faculdade São Leopoldo Mandic
Eligibility
Age
4 Years to 10 Years
Inclusion criteria
Inclusion criteria: Children with cognitive impairment; both sexes; diagnosis of mild to moderate learning deficit; age range from 4 to 10 years; with the presence of extensive caries lesions involving more than one surface of the tooth, presenting an International Caries Detection and Assessment System score of 5 or 6; with the possibility of sending for 12 months; in which the guardians agreed and agreed to the Free and Informed Consent Form; if the patient had more than one tooth with caries lesion involving two or more surfaces, this patient contributed more than one tooth to a sample
Exclusion criteria
Exclusion criteria: Children whose teeth had pulp exposure; who presented spontaneous pain; teeth in the process of advanced rhizolysis presenting mobility; presence of swelling or fistula near the tooth; furcation or cervical lesion; teeth with restorations, sealants or defects in enamel formation were excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Satisfaction of parents/guardians: Through the questionnaire that assesses the appearance of children's teeth, it is expected that parents consider the aesthetic assessment to be a success. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess longevity, the teeth will be evaluated at baseline, 6 months and 12 months after the initial intervention, through clinical examination. To evaluate restorations with band and resin glass ionomer cement, the evaluation methodology proposed by Phantumvanit et al. (1996) was used, while for the evaluation of steel crowns by the Hall technique, the criterion proposed by Innes et al. (2007) was used. It is expected that orthodontic bands cemented with glass ionomer will present a survival similar to the Hall Technique and will be a good treatment alternative for extensive caries lesions in deciduous teeth.;Marginal adaptation was assessed according to the clinical and radiographic criteria proposed by Sharaf and Farsi (2004) and presented in the form of a table filled out by the operator immediately after performing the baseline procedure, and at the 6-month and 12-month follow-up visits. The radiographs were taken using a radiographic positioner to ensure standardization. Through this analysis, it is expected that the teeth restored with orthodontic bands cemented with glass ionomer will present good adaptation and marginal extension and allow adequate proximal contact.;To assess the perception of parents/guardians regarding the treatment performed, the Child’s and Parent’s Questionnaire about Teeth Appearance (Furtado GE et al. 2012) was used immediately after the first treatment session. The examiners instructed parents and guardians to express their true opinion. It is expected that after submitting patients to restorative procedures, parents will present a higher degree of satisfaction than before treatment. ;For the cost-effectiveness analysis, the following expenses were considered for parents/guardians: travel expenses, deductions from the guardian's work, and expenses with third parties to stay with another child were also included in the analysis. Based on data collected from cost-effectiveness and analysis, a specific model was proposed for cost es | — |
Countries
Brazil
Contacts
Public ContactAna Cristina Pedroza
Instituto e Centro de Pesquisas São Leopoldo Mandic
Outcome results
None listed