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The aim of the study is to compare application of sealants together with fluoride varnishes versus only fluoride varnishes in preventing caries lesions development in the occlusal surface of first permanent molars of children with ASDs.
The aim of the study is to evaluate if the application of pit and fissure sealants together with fluoride varnishes is more effective than the application of the only fluoride varnishes in preventing caries lesions development in the occlusal surface of first permanent molars of children with ASDs.
Patients with at least 10-year follow-up and ASDs are recruited and allocated to two cohort according to the strategy adopted for prevention of caries in first permanent molars: FA group (only fluoride varnishes) and FA+S group (sealants together with fluoride varnishes).
Caries incidence and sealants retention after the follow-up period are recorded. Demographic and clinical characteristics of patients at first dental visit are also recorded (age, level of cooperation, presence of systemic diseases other than ASDs, caries severity) to evaluate if they play a potential protective and/or risk factors for caries development.
Logistic and multivariate analysis are run to evaluate caries incidence and retention rate of sealants in first permanent molars over a period of at least 10 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluoride varnish (FA group) | Application of 5% NaF varnish onto first permanent molars | ||
| Fluoride varnish + dental sealant (FA+S group) | Application of 5% NaF varnish plus pit and fissure sealant onto first permanent molars |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoride varnish and pit and fissure sealants onto first permanent molars | Procedure | Quarterly application of fluoride varnish. Application of pit and fissure sealant, and replacements if necessary. |
| Measure | Description | Time Frame |
|---|---|---|
| Survival rates from dental caries | Percentage of first permanent molars free from caries | 15 years |
| Measure | Description | Time Frame |
|---|---|---|
| Survival rates of pit and fissure sealant | Percentage of pit and fissure sealant sound | 15 years |
| Evaluation of confounders | Evaluation if patient's variables at the first dental visit, such as age, number of dental caries, cooperation level, are positively or negatively associated with first permanent molars decay rates overtime. |
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Inclusion Criteria:
Exclusion Criteria:
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Primary care clinic: participants were enrolled among those who have being received dental care at the Dental Service for ASD children of San Paolo Hospital, Milan, Italy.
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| Name | Affiliation | Role |
|---|---|---|
| Maria Grazia MG Cagetti, Prof | University of Milan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dental Clinic San Paolo Hospital | Milan | 20142 | Italy |
Data will be available upon request
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| 15 years |
| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D003731 | Dental Caries |
| C536528 | Van der Woude syndrome |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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