Autism Spectrum DisorderCREASEDNCT03830541
Oral Health Care in Autism Spectrum Disorder
An observational study of Autism Spectrum Disorder and Autism, run by University of Novi Sad.
Trial summary
Persons with autism spectrum disorder (ASD) are characterized by impairments in social interactions, speech and communication, restricted patterns of behaviour, and unusual sensory sensitivities. Read more about this study
- Who is it for?
- Ages 3 to 80 years
- Conditions the study is for
- Autism Spectrum Disorder, Autism
- What is being tested?
- Oral care delivery analysis in participants with ASD
- Type of treatment
- Pill or oral medicine
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2019to 20 Dec 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants with ASD treated at the Dental Clinic of Vojvodina during 5 years observation period
Who may be able to join
- -
Who cannot join
- Diagnosis of a autism spectrum disorder not confirmed by a physician
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism Spectrum Disorder, Autism
- Being tested
- Oral care delivery analysis in participants with ASD
- Keywords
- oral health, dental care, general anaesthesia, tooth loss
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral care delivery analysis in participants with ASDOther
The analysis of oral health status, tooth loss, oral rehabilitation, characteristics of routine dental treatment and treatment in general anaesthesia in persons with ASD
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Health Status as measured by number of subjects with missing teeth
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.
Measured: 3 months
Oral Health Status as measured by untreated dental decay
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
Measured: 6months
Oral health care delivery analysis
Reporting the mean numbers of regular dental treatment visits and general anesthesia treatment in various subgroups of participants
Measured: 3 months
Secondary outcomes (2)
Tooth loss in institutionalised participants
Comparison of proportions of permanent teeth extractions as calculated as T fraction in DMFT index between institutionalised and non institutionalised participants
Measured: 3 months
Tooth loss in general anaesthesia
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start20 Mar 2019 (estimated)
- Primary completion20 Jul 2019 (estimated)
- Study completion20 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum 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
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Novi Sad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bojan Petrovic, University of Novi Sad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830541
- Sponsor's protocol ID
- 01789/2019
- Acronym
- CREASED
- Status last verified
- Feb 2019
- First submitted
- 2 Feb 2019
- Last updated
- 13 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pattern of Oral Health Care Delivery for Persons With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT03830541
- Acronym / sponsor ID
- CREASED / 01789/2019
- Conditions
- Autism Spectrum Disorder, Autism
- Keywords
- oral health, dental care, general anaesthesia, tooth loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of Novi SadUniversity, hospital or other
- Study start
- 20 Mar 2019 (estimated)
- Primary completion
- 20 Jul 2019 (estimated)
- Study completion
- 20 Dec 2019 (estimated)
- First posted
- 5 Feb 2019 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 3 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with ASD treated at the Dental Clinic of Vojvodina during 5 years observation period
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- Diagnosis of a autism spectrum disorder not confirmed by a physician
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 |
|---|---|---|
| Oral care delivery analysis in participants with ASDThe analysis of oral health status, tooth loss, oral rehabilitation, characteristics of routine dental treatment and treatment in general anaesthesia in persons with ASD | Other | – |
Primary outcome
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.
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
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
2 secondary outcomes
Tooth loss in institutionalised participants
Time frame: 3 months
Tooth loss in general anaesthesia
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder and Autism, run by University of Novi Sad.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bojan B Petrovic, PhD (+38163342639, bojan.petrovic@mf.uns.ac.rs), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Health Status as measured by number of subjects with missing teeth (time frame: 3 months). The study lists 3 primary outcomes in all. 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 13 Mar 2019.