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This protocol aims to assess the cost-efficacy and applicability of the treatment of lesions moderate caries using sealants as an alternative to the restorations on occlusal surfaces of deciduous teeth. Initially, a non-inferiority study was designed in order to verify if sealing could be non-inferior than restoration. In this case, it could be preferable since it is less invasive. Therefore, cost will be put forward into the analysis considering even reintervention during the follow-ups (cost-efficacy analyses). Finally, the acceptability could be another differential point between treatments.
This study aims to evaluate the cost-efficacy and applicability of the treatment of lesions moderate caries using sealants as an alternative to the restorations on occlusal surfaces of deciduous teeth. 96 children aged 3-6 years will be selected. Children must have at least one occlusal surface classified as scores 3 or 4 of International Caries Detection and Assessment System (ICDAS). Children will be randomly allocated according to the treatment: glass ionomer sealant and restoration with glass ionomer. After treatment, teeth will be assessed clinically after 6, 12, 18 and 24 months by trained and blinded examiners regarding the treatment received. The need of reintervention initially treated, either by failures that require repeating of the same procedure or for progression of caries lesions will be considered as primary outcomes. The secondary outcomes will be the chil's acceptability to the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| restoration - control | Active Comparator | Restoration |
|
| sealant - test | Experimental | Sealant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ionomer Restoration (control) | Procedure | Restoration of moderate caries lesions after partial caries removal using high viscosity glass ionomer cements |
|
| Measure | Description | Time Frame |
|---|---|---|
| Need of reintervention | Need of reintervention will be considered as all failures after initial treatment that demand repair and/or caries progression associated to the treated lesion at baseline. After cleaning, It will be analyzed the clinical evaluation of restorations and sealants, will be assessed the presence of caries lesions in dentin and / or evolution of ICDAS scores and if will be necessary other types of treatment, such as endodontics and extraction of teeth included. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Child's reported discomfort | The discomfort will be an outcome collected right after the end of treatment, using Wong baker scale | 1st day |
| Duration of treatments | Time spent in interventions will be recorded. |
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Inclusion Criteria:
They will be included in this study children:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mariana M Braga, PhD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of São Paulo | São Paulo | São Paulo | 05508-000 | Brazil |
Publication of all results, accessibility to data if necessary
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D005899 | Glass Ionomer Cements |
| ID | Term |
|---|---|
| D003738 | Dental Cements |
| D003764 | Dental Materials |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
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|
| Ionomer Sealant (test) | Procedure | Sealing of moderate caries lesions without any caries removal or cavity opening. |
|
|
| Oral hygiene orientation and professional fluoride application | Procedure | Oral hygiene orientation and professional fluoride application |
|
| 1st day |
| D013676 |
| Technology, Industry, and Agriculture |