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Completed

NCT Number: NCT05146479

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

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.

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Key information

Age range

3 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dental Clinic San Paolo Hospital

Milan, 20142, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluoride varnish and pit and fissure sealants onto first permanent molars

Procedure

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

Primary outcomes

  1. Survival rates from dental caries

    Time frame: 15 years

    Percentage of first permanent molars free from caries

Secondary outcomes

  1. Survival rates of pit and fissure sealant

    Time frame: 15 years

    Percentage of pit and fissure sealant sound

  2. Evaluation of confounders

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2021
Study completion
2021
First posted
Dec 6, 2021
Registry last updated
Dec 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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