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Atypical cavities, which involve more than two surfaces being one of them vestibular or lingual/palatine, are a challenge for restorative dentistry, since the risk of failure of the restorations are related to the number of surfaces involved. Thus, the objective of this project is to conduct a randomized clinical trial in order to evaluate the efficacy and patient-centered outcomes of a chemically-activated alkasite composite resin in atypical lesions of deciduous molars. Deciduous molars of children between 4 and 7 years of age with at least one atypical cavity lesion in deciduous molars will be selected for the ECR. The selected teeth will be randomly divided into two groups: Chemically activated composite resin Alkasite and resin-Modified glass ionomer cement. Clinical and radiographic follow-up of the lesions will be performed for 6 and 12 months. The efficacy of the treatments will be evaluated by the longevity of the restoring procedures and the arrestment of the caries lesions. Patient-centered outcomes will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemically activated Composite resin Alkasite | Experimental | Single placement of composite resin on atypical cavities. |
|
| Resin-Modified Glass ionomer Cement | Active Comparator | Single placement of Resin-Modified Glass ionomer Cement on atypical cavities. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dental Restoration with Chemically activated Composite resin Alkasite | Procedure | Selective removal of dental caries with manual instruments, under relative isolation, application of universal adhesive system and restoration with chemically activated composite resin Alkasite. |
| Measure | Description | Time Frame |
|---|---|---|
| Survival of restoration | To evaluate the survival of restoration by clinical examination with FDI index. | 12 months after treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Caries lesion progression | For the evaluation of caries progression, the interproximal radiographic examination will be used to verify an increase of radiolucent image under restoration. | 12 months after treatment. |
| Secondary caries lesion or on the surface adjacent to the restored tooth |
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Inclusion Criteria:
• Children will be included who have at least one posterior tooth with atypical caries lesion.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculdade Sao Leopoldo Mandic | Recruiting | Campinas | São Paulo | 13045-755 | Brazil |
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Compare the survival of restorations performed with chemically activated composite resin alkasite and resin- modified glass ionomer cement.
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| Dental Restoration with Resin-Modified Glass ionomer Cement | Procedure | Selective removal of dental caries with manual instruments, under relative isolation, application of polyacrylic acid and restoration with resin-modified glass ionomer cement. |
|
Presence of caries lesion on the surface adjacent to the restored tooth or on the margins of the restoration by means of visualClinical Examination |
| 12 months after treatment. |
| Perception of children and parents/guardians | To evaluate the satisfaction of the children in relation to the treatment performed. The questionnaire will be used " Child's and parent's questionnaire about teeth appearance". | 6 months after treatment. |
| Operator perception | It will be employed a questionnaire after the completion of the treatment performed. It will also be added a question about the behavior of children during the procedure, which will be categorized as - great behavior, regular or bad. | 6 months after the restoration. |
| Parents/Guardians Satisfaction | The parents/guardians will be questioned about the satisfaction regarding the treatment performed in the child. The answer will be scored by a likert scale. | 6 months after restoration. |
| Child discomfort | The child will also be questioned as to the discomfort in relation to the treatment performed. For this will be used the scale of faces of Wong-Baker. | Immediately after the treatment. |
| Post Operative sensitivity of the child | The child will also be questioned about the sensitivity of the restorative procedure. For this, the Wong-Baker face scale will be used. | 7 ° day after the restorative procedure. |
| Oral health-related quality of life | The validated Brazilian version of Early Childhood Oral Health Impact Scale (ECOHIS) will be applied to children and should be answered by their parents. | 6 month of restorative treatment. |
| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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