CClinicalTrials.gg
Status unknownNCT03830541CREASEDUpdated Mar 13, 2019

Oral Health Care in Autism Spectrum Disorder

An observational study in Autism Spectrum Disorder and Autism, sponsored by University of Novi Sad. Status unknown. Open to participants aged 3 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-03-13.

Sponsored by University of Novi Sad · Observational

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
52
Ages
3 Years to 80 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Autism Spectrum Disorder
  • Autism

Keywords

  • oral health
  • dental care
  • general anaesthesia
  • tooth loss
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In context

Autistic Disorder

1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.

This study's planned enrollment of 52 is below the median of 102 across 267 observational studies indexed under Autistic Disorder.

Browse Autistic Disorder studies →

Lead sponsor

University of Novi Sad is the lead sponsor of 26 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 80 Years
Sexes eligible
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

Eligibility criteria

Inclusion Criteria:

-

Exclusion Criteria:

  • Diagnosis of a autism spectrum disorder not confirmed by a physician
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
52 participants (estimated)
Patient registry
No

Interventions

  • OtherOral 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

  2. 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

    Time frame: 6months

  3. Oral health care delivery analysis

    Reporting the mean numbers of regular dental treatment visits and general anesthesia treatment in various subgroups of participants

    Time frame: 3 months

Secondary outcomes

  1. 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

    Time frame: 3 months

  2. 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

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03830541
Lead sponsor
University of Novi Sad
Responsible party
Bojan Petrovic (Principal Investigator, University of Novi Sad) — Principal investigator
First posted
Feb 5, 2019
Start date
Mar 20, 2019 (estimated)
Primary completion
Jul 20, 2019 (estimated)
Completion
Dec 20, 2019 (estimated)
Last update
Mar 13, 2019

Study contacts

Bojan B Petrovic, PhD
Contact
bojan.petrovic@mf.uns.ac.rs
+38163342639

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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