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Oral Health Care in Autism Spectrum Disorder (CREASED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03830541
Recruitment Status : Not yet recruiting
First Posted : February 5, 2019
Last Update Posted : March 13, 2019
Information provided by (Responsible Party):
Bojan Petrovic, University of Novi Sad

Brief 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. There are not many studies available reporting oral health status, dental care needs and oral health care protocol for persons with an ASD.

Condition or disease Intervention/treatment
Autism Spectrum Disorder Autism Other: Oral care delivery analysis in participants with 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.

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Study Type : Observational
Estimated Enrollment : 52 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Pattern of Oral Health Care Delivery for Persons With Autism Spectrum Disorder
Estimated Study Start Date : March 20, 2019
Estimated Primary Completion Date : July 20, 2019
Estimated Study Completion Date : December 20, 2019

Intervention Details:
  • Other: Oral care delivery analysis in participants with ASD
    The analysis of oral health status, tooth loss, oral rehabilitation, characteristics of routine dental treatment and treatment in general anaesthesia in persons with ASD

Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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

Secondary Outcome Measures :
  1. 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

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with ASD treated at the Dental Clinic of Vojvodina during 5 years observation period

Inclusion Criteria:

Exclusion Criteria:

  • Diagnosis of a autism spectrum disorder not confirmed by a physician

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03830541

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Contact: Bojan B Petrovic, PhD +38163342639

Sponsors and Collaborators
University of Novi Sad

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Responsible Party: Bojan Petrovic, Principal Investigator, University of Novi Sad Identifier: NCT03830541     History of Changes
Other Study ID Numbers: 01789/2019
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bojan Petrovic, University of Novi Sad:
oral health
dental care
general anaesthesia
tooth loss

Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders