NCT03830541

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

March 20, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

March 13, 2019

Status Verified

February 1, 2019

Enrollment Period

4 months

First QC Date

February 2, 2019

Last Update Submit

March 12, 2019

Conditions

Keywords

oral healthdental caregeneral anaesthesiatooth loss

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

    6months

  • Oral health care delivery analysis

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

    3 months

Secondary Outcomes (2)

  • Tooth loss in institutionalised participants

    3 months

  • Tooth loss in general anaesthesia

    6 months

Interventions

The analysis of oral health status, tooth loss, oral rehabilitation, characteristics of routine dental treatment and treatment in general anaesthesia in persons with ASD

Eligibility Criteria

Age3 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with ASD treated at the Dental Clinic of Vojvodina during 5 years observation period

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic DisorderTooth Loss

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesTooth Diseases

Central Study Contacts

Bojan B Petrovic, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 2, 2019

First Posted

February 5, 2019

Study Start

March 20, 2019

Primary Completion

July 20, 2019

Study Completion

December 20, 2019

Last Updated

March 13, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share