Clinical trial NCT05146479: Effectiveness of Sealants and Fluoride Varnish in Caries Prevention in Children With Autism Spectrum Disorders
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autistic Disorder
Dental Caries
Pit and Fissure Caries
Keywords: Dental sealant
Pit and Fissure sealant
Preventive dentistry
Fluoride varnish
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2021-12-06
Enrollment: 232
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Survival rates from dental caries
timeFrame: 15 years
Secondary outcomes:
measure: Survival rates of pit and fissure sealant
timeFrame: 15 years
measure: Evaluation of confounders
timeFrame: 15 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Dental Clinic San Paolo Hospital
Study officials:
affiliation: University of Milan
name: Maria Grazia MG Cagetti, Prof
role: STUDY_CHAIR
References: