Autistic DisorderNCT05146479
Effectiveness of Sealants and Fluoride Varnish in Caries Prevention in Children With Autism Spectrum Disorders
An observational study of Autistic Disorder and Dental Caries, run by University of Milan at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- Autistic Disorder, Dental Caries, Pit and Fissure Caries
- What is being tested?
- Fluoride varnish and pit and fissure sealants onto first permanent molars
- Type of treatment
- Surgery or procedure
- How many people
- 232 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2006to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 14 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- ASDs
- age less than 14 years
- written declaration of informed consent signed by parents/guardians
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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.
- Conditions
- Autistic Disorder, Dental Caries, Pit and Fissure Caries
- Being tested
- Fluoride varnish and pit and fissure sealants onto first permanent molars
- Keywords
- Dental sealant, Pit and Fissure sealant, Preventive dentistry, Fluoride varnish
- Medical subject headings
- Autistic Disorder, Dental Caries, Van der Woude syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoride varnish and pit and fissure sealants onto first permanent molarsProcedure or surgery
Quarterly application of fluoride varnish. Application of pit and fissure sealant, and replacements if necessary.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Fluoride varnish and pit and fissure sealants onto first permanent molars |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rates from dental caries
Percentage of first permanent molars free from caries
Measured: 15 years
Secondary outcomes (2)
Survival rates of pit and fissure sealant
Percentage of pit and fissure sealant sound
Measured: 15 years
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.
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start1 Jan 2006
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Grazia Cagetti, University of Milan
- Investigators
- Maria Grazia MG Cagetti, Prof, Study chair, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146479
- Sponsor's protocol ID
- 0000546
- Status last verified
- Dec 2021
- First submitted
- 22 Nov 2021
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be available upon request
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05146479
- Acronym / sponsor ID
- 0000546
- Conditions
- Autistic Disorder, Dental Caries, Pit and Fissure Caries
- Keywords
- Dental sealant, Pit and Fissure sealant, Preventive dentistry, Fluoride varnish
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 6 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluoride varnish (FA group) | – | –Application of 5% NaF varnish onto first permanent molars |
| Fluoride varnish + dental sealant (FA+S group) | – | Procedure: Fluoride varnish and pit and fissure sealants onto first permanent molarsApplication of 5% NaF varnish plus pit and fissure sealant onto first permanent molars |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- ASDs
- age less than 14 years
- written declaration of informed consent signed by parents/guardians
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluoride varnish and pit and fissure sealants onto first permanent molarsQuarterly application of fluoride varnish. Application of pit and fissure sealant, and replacements if necessary. | Procedure or surgery | Fluoride varnish + dental sealant (FA+S group) |
Primary outcome
Survival rates from dental caries
Time frame: 15 years
Percentage of first permanent molars free from caries
2 secondary outcomes
Survival rates of pit and fissure sealant
Time frame: 15 years
Evaluation of confounders
Time frame: 15 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Individual participant dataSharing planned: Undecided. Data will be available upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Grazia MG Cagetti, Prof study chair
University of Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autistic Disorder and Dental Caries, run by University of Milan at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rates from dental caries (time frame: 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.