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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05146479
Enrollment
232
Registered
2021-12-06
Start date
2006-01-01
Completion date
2021-06-30
Last updated
2021-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autistic Disorder, Dental Caries, Pit and Fissure Caries

Keywords

Dental sealant, Pit and Fissure sealant, Preventive dentistry, Fluoride varnish

Brief 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.

Interventions

PROCEDUREFluoride 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.

Sponsors

University of Milan
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 14 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Survival rates from dental caries15 yearsPercentage of first permanent molars free from caries

Secondary

MeasureTime frameDescription
Survival rates of pit and fissure sealant15 yearsPercentage of pit and fissure sealant sound
Evaluation of confounders15 yearsEvaluation 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026