NCT05146479

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
232

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
15.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 6, 2021

Completed
Last Updated

December 21, 2021

Status Verified

December 1, 2021

Enrollment Period

15.5 years

First QC Date

November 22, 2021

Last Update Submit

December 4, 2021

Conditions

Autistic DisorderDental CariesPit and Fissure Caries

Keywords

Dental sealantPit and Fissure sealantPreventive dentistryFluoride varnish

Outcome Measures

Primary Outcomes (1)

  • Survival rates from dental caries

    Percentage of first permanent molars free from caries

    15 years

Secondary Outcomes (2)

  • Survival rates of pit and fissure sealant

    15 years

  • Evaluation of confounders

    15 years

Study Arms (2)

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

Interventions

Fluoride varnish and pit and fissure sealants onto first permanent molarsPROCEDURE

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

Fluoride varnish + dental sealant (FA+S group)

Eligibility Criteria

Age3 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic: participants were enrolled among those who have being received dental care at the Dental Service for ASD children of San Paolo Hospital, Milan, Italy.

You may qualify if:

  • ASDs
  • age less than 14 years
  • written declaration of informed consent signed by parents/guardians

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dental Clinic San Paolo Hospital

Milan, 20142, Italy

Location

MeSH Terms

Conditions

Autistic DisorderDental CariesVan der Woude syndrome

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersTooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Maria Grazia MG Cagetti, Prof

    University of Milan

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Maria Grazia Cagetti

Study Record Dates

First Submitted

November 22, 2021

First Posted

December 6, 2021

Study Start

January 1, 2006

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

December 21, 2021

Record last verified: 2021-12

Locations

IT(1)