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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Novi Sad

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 20, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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