Effectiveness of Sealants and Fluoride Varnish in Caries Prevention in Children With Autism Spectrum Disorders

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Long-term Retrospective Cohort Study in Children With Autism Spectrum Disorders on the Effectiveness of Dental Sealants and Fluoride Varnish to Prevent the Occurrence of New Caries

Conditions
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Autistic Disorder, Dental Caries, Pit and Fissure Caries

Intervention / Treatment
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* Procedure: Fluoride varnish and pit and fissure sealants onto first permanent molars


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASDs age less than 14 years written declaration of informed consent signed by parents/guardians Exclusion Criteria: incomplete clinical records missing five or more dental check-ups over the follow-up period oral or dental care provided in sedation or general anesthesia follow-up less than 15 years

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fluoride varnish (FA group)<br>Application of 5% NaF varnish onto first permanent molars | |
| Fluoride varnish + dental sealant (FA+S group)<br>Application of 5% NaF varnish plus pit and fissure sealant onto first permanent molars | Procedure: Fluoride varnish and pit and fissure sealants onto first permanent molars<br>* Quarterly application of fluoride varnish. Application of pit and fissure sealant, and replacements if necessary.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rates from dental caries | Percentage of first permanent molars free from caries | 15 years | 

Secondary Outcome Measures

| Outcome Measure | 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. | 15 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental sealant, Pit and Fissure sealant, Preventive dentistry, Fluoride varnish