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

University of Milan232 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

232

Conditions

Autistic Disorder Dental Caries Pit and Fissure Caries

Interventions

Fluoride varnish and pit and fissure sealants onto first permanent molarsPROCEDURE

Quarterly application of fluoride varnish. Application of pit and fissure sealant, and replacements if necessary.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 14 Years

Medical Language ↔ Plain English

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

Locations (1)

Dental Clinic San Paolo Hospital

Milan, Italy

Outcomes

Primary Outcomes

Survival rates from dental caries

Percentage of first permanent molars free from caries

Time frame: 15 years

Secondary Outcomes

Survival rates of pit and fissure sealant

Percentage of pit and fissure sealant sound

Time frame: 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.

Time frame: 15 years

Data from ClinicalTrials.gov

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