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

NCT ID: NCT05146479

Last Updated: 2021-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

232 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-01

Study Completion Date

2021-06-30

Brief Summary

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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

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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.

Conditions

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Autistic Disorder Dental Caries Pit and Fissure Caries

Keywords

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Dental sealant Pit and Fissure sealant Preventive dentistry Fluoride varnish

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Fluoride varnish (FA group)

Application of 5% NaF varnish onto first permanent molars

No interventions assigned to this group

Fluoride varnish + dental sealant (FA+S group)

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

Fluoride varnish and pit and fissure sealants onto first permanent molars

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Milan

OTHER

Sponsor Role lead

Responsible Party

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Maria Grazia Cagetti

Prof. Maria Grazia Cagetti

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Grazia MG Cagetti, Prof

Role: STUDY_CHAIR

University of Milan

Locations

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Dental Clinic San Paolo Hospital

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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0000546

Identifier Type: -

Identifier Source: org_study_id