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

Sponsor

University of Milan (Other)

Overall Status

Completed

CT.gov ID

NCT05146479

Collaborator

(none)

232

Enrollment

Location

185.9

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autistic Disorder Dental Caries Pit and Fissure Caries	Procedure: Fluoride varnish and pit and fissure sealants onto first permanent molars

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 Design

Study Type:

Observational

Actual Enrollment :

232 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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

Actual Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Jun 30, 2021

Actual Study Completion Date :

Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Fluoride varnish (FA group) Application of 5% NaF varnish onto first permanent molars
Fluoride varnish + dental sealant (FA+S group) Application of 5% NaF varnish plus pit and fissure sealant onto first permanent molars	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.

Arm

Intervention/Treatment

Fluoride varnish (FA group)

Application of 5% NaF varnish onto first permanent molars

Fluoride varnish + dental sealant (FA+S group)

Application of 5% NaF varnish plus pit and fissure sealant onto first permanent molars

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.

Outcome Measures

Primary Outcome Measures

Survival rates from dental caries [15 years]
Percentage of first permanent molars free from caries

Secondary Outcome Measures

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.