NCT05146479

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 232 (actual)
• Sponsor: University of Milan · Academic / Other
• Sex: All
• Age: 3 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Autistic Disorder
• Dental Caries
• Pit and Fissure Caries

Interventions

Type	Name	Description
PROCEDURE	Fluoride varnish and pit and fissure sealants onto first permanent molars	Quarterly application of fluoride varnish. Application of pit and fissure sealant, and replacements if necessary.

Timeline

• Start date: 2006-01-01
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2021-12-06
• Last updated: 2021-12-21

Locations

1 site across 1 country: Italy