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

Completed

• Conditions: Dental Caries; Autistic Disorder; Pit and Fissure Caries
• Interventions: Procedure: Fluoride varnish and pit and fissure sealants onto first permanent molars

• Registration Number: NCT05146479
• Lead Sponsor: University of Milan

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.

Study Timeline

• Study Start: 2006-01-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Study First Submitted: 2021-11-22
• Study First Submitted QC: 2021-11-22
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-04
• Study First Posted: 2021-12-06
• Last Update Posted: 2021-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 232

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fluoride varnish + dental sealant (FA+S group)	Fluoride varnish and pit and fissure sealants onto first permanent molars	Application of 5% NaF varnish plus pit and fissure sealant onto first permanent molars

Primary Outcome Measures

Name	Time	Method
Survival rates from dental caries	15 years	Percentage of first permanent molars free from caries

Secondary Outcome Measures

Name	Time	Method
Survival rates of pit and fissure sealant	15 years	Percentage of pit and fissure sealant sound
Evaluation of confounders	15 years	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.

Trial Locations

Locations (1)

Dental Clinic San Paolo Hospital; 🇮🇹 Milan, Italy