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
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 |
Verified date | December 2021 |
Source | University of Milan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Dental Clinic San Paolo Hospital | Milan |
Lead Sponsor | Collaborator |
---|---|
University of Milan |
Italy,
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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