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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03830541
Other study ID # 01789/2019
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 20, 2019
Est. completion date December 20, 2019

Study information

Verified date February 2019
Source University of Novi Sad
Contact Bojan B Petrovic, PhD
Phone +38163342639
Email bojan.petrovic@mf.uns.ac.rs
Is FDA regulated No
Health authority
Study type Observational

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 52
Est. completion date December 20, 2019
Est. primary completion date July 20, 2019
Accepts healthy volunteers No
Gender All
Age group 3 Years to 80 Years
Eligibility Inclusion Criteria:

Exclusion Criteria:

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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Novi Sad

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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 3 months
Secondary 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 6 months
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