- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03830541
Oral Health Care in Autism Spectrum Disorder (CREASED)
March 12, 2019 updated by: Bojan Petrovic, University of Novi Sad
A Pattern of Oral Health Care Delivery for Persons With Autism Spectrum Disorder
Persons with autism spectrum disorder (ASD) are characterized by impairments in social interactions, speech and communication, restricted patterns of behaviour, and unusual sensory sensitivities.
There are not many studies available reporting oral health status, dental care needs and oral health care protocol for persons with an ASD.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Despite the fact that there appears to be no known ASD specific dental and oral manifestations, there are consistent reports that persons with ASD exhibit significantly poorer oral health epidemiological profile when compared to their neurotypical counterparts.
In addition to that, it has been reported that persons with ASD to substantial extent have a special health care needs and are almost twice as likely to have unmet oral health care needs as their typically developing peers regardless socioeconomic and cultural background.
All these oral health related problems might arise because of ASD related challenging behaviors such as communication limitations, personal neglect, self-injurious behaviors, dietary habits, effects of medications, resistance to receiving dental care, hyposensitivity to pain, and possible avoidance of social contact.
Frequently overlooked but very important reason is the lack of oral care providers who are willing to serve this population.
As a results, oral health problems and unmet oral health needs transfer from childhood to adult period in persons with ASD.The broad, long-term objective of the investigator's proposed research is to describe the oral health status, oral health related behaviors, oral care delivery pattern, limitations of routine dental treatment and requirements for use general anaesthesia for oral health care of patients with ASD.
Oral health status, pattern of oral health care delivery, dental treatment needs met in routine dental treatment and general anaesthesia will be analysed retrospectively on 52 participants with diagnosed ASD who were treated and monitored at the Paediatric Dentistry Department, Dental Clinic of Vojvodina, Faculty of Medicine, University of Novi Sad during 5 years (2013-2018) observation period.
Conditions assessed will include, dental caries, missed teeth, filled teeth (DMFT index), restorations, bruxism, delayed eruption/missing teeth, oral infection, injuries, general health status, dental treatment acceptance (Frankle scale), dental treatment attendance, routine dental treatment and general anaesthesia dental treatment assessment.
Study Type
Observational
Enrollment (Anticipated)
52
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants with ASD treated at the Dental Clinic of Vojvodina during 5 years observation period
Description
Inclusion Criteria:
-
Exclusion Criteria:
- Diagnosis of a autism spectrum disorder not confirmed by a physician
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oral Health Status as measured by number of subjects with missing teeth
Time Frame: 3 months
|
The number of missing teeth (T) is quantified using the D (decayed) component of the DMFT Index.
The DMFT Index quantifies the dental caries experience by the number of decayed (D), missing (M), and filled (F) teeth (T).
The number of subjects presenting with missing teeth will be reported.
|
3 months
|
Oral Health Status as measured by untreated dental decay
Time Frame: 6months
|
Untreated dental decay will be determined by either the presence of coronal caries quantified by using the D (decayed teeth) component of the DMF (decayed, missed, filled) Index.
The DMF Index quantifies the dental caries experience by the number of decayed (D), missing (M), and filled (F) teeth.
The higher proportion of D in DMFT score suggest higher caries activity and poorer epidemiological profile
|
6months
|
Oral health care delivery analysis
Time Frame: 3 months
|
Reporting the mean numbers of regular dental treatment visits and general anesthesia treatment in various subgroups of participants
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tooth loss in institutionalised participants
Time Frame: 3 months
|
Comparison of proportions of permanent teeth extractions as calculated as T fraction in DMFT index between institutionalised and non institutionalised participants
|
3 months
|
Tooth loss in general anaesthesia
Time Frame: 6 months
|
Comparison of proportions of permanent teeth extractions as calculated as T fraction in DMFT index between participants treated solely in general anaesthesia and participants exclusively treated during routine dental treatment
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 20, 2019
Primary Completion (Anticipated)
July 20, 2019
Study Completion (Anticipated)
December 20, 2019
Study Registration Dates
First Submitted
February 2, 2019
First Submitted That Met QC Criteria
February 4, 2019
First Posted (Actual)
February 5, 2019
Study Record Updates
Last Update Posted (Actual)
March 13, 2019
Last Update Submitted That Met QC Criteria
March 12, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01789/2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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