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NCT05146479 Clinical Trial

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

Dental Caries Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05146479
Other study ID # 0000546
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2006
Est. completion date June 30, 2021

Study information
Verified date December 2021
Source University of Milan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 232
Est. completion date June 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 3 Years to 14 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Italy Dental Clinic San Paolo Hospital Milan

Sponsors (1)
Lead Sponsor Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Survival rates from dental caries Percentage of first permanent molars free from caries 15 years
Secondary Survival rates of pit and fissure sealant Percentage of pit and fissure sealant sound 15 years
Secondary 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. 15 years
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