<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03830541</url>
  </required_header>
  <id_info>
    <org_study_id>01789/2019</org_study_id>
    <nct_id>NCT03830541</nct_id>
  </id_info>
  <brief_title>Oral Health Care in Autism Spectrum Disorder</brief_title>
  <acronym>CREASED</acronym>
  <official_title>A Pattern of Oral Health Care Delivery for Persons With Autism Spectrum Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Novi Sad</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Novi Sad</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Persons with autism spectrum disorder (ASD) are characterized by impairments in social&#xD;
      interactions, speech and communication, restricted patterns of behaviour, and unusual sensory&#xD;
      sensitivities. There are not many studies available reporting oral health status, dental care&#xD;
      needs and oral health care protocol for persons with an ASD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite the fact that there appears to be no known ASD specific dental and oral&#xD;
      manifestations, there are consistent reports that persons with ASD exhibit significantly&#xD;
      poorer oral health epidemiological profile when compared to their neurotypical counterparts.&#xD;
      In addition to that, it has been reported that persons with ASD to substantial extent have a&#xD;
      special health care needs and are almost twice as likely to have unmet oral health care needs&#xD;
      as their typically developing peers regardless socioeconomic and cultural background. All&#xD;
      these oral health related problems might arise because of ASD related challenging behaviors&#xD;
      such as communication limitations, personal neglect, self-injurious behaviors, dietary&#xD;
      habits, effects of medications, resistance to receiving dental care, hyposensitivity to pain,&#xD;
      and possible avoidance of social contact. Frequently overlooked but very important reason is&#xD;
      the lack of oral care providers who are willing to serve this population. As a results, oral&#xD;
      health problems and unmet oral health needs transfer from childhood to adult period in&#xD;
      persons with ASD.The broad, long-term objective of the investigator's proposed research is to&#xD;
      describe the oral health status, oral health related behaviors, oral care delivery pattern,&#xD;
      limitations of routine dental treatment and requirements for use general anaesthesia for oral&#xD;
      health care of patients with ASD. Oral health status, pattern of oral health care delivery,&#xD;
      dental treatment needs met in routine dental treatment and general anaesthesia will be&#xD;
      analysed retrospectively on 52 participants with diagnosed ASD who were treated and monitored&#xD;
      at the Paediatric Dentistry Department, Dental Clinic of Vojvodina, Faculty of Medicine,&#xD;
      University of Novi Sad during 5 years (2013-2018) observation period. Conditions assessed&#xD;
      will include, dental caries, missed teeth, filled teeth (DMFT index), restorations, bruxism,&#xD;
      delayed eruption/missing teeth, oral infection, injuries, general health status, dental&#xD;
      treatment acceptance (Frankle scale), dental treatment attendance, routine dental treatment&#xD;
      and general anaesthesia dental treatment assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 20, 2019</start_date>
  <completion_date type="Anticipated">December 20, 2019</completion_date>
  <primary_completion_date type="Anticipated">July 20, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Oral Health Status as measured by number of subjects with missing teeth</measure>
    <time_frame>3 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oral Health Status as measured by untreated dental decay</measure>
    <time_frame>6months</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oral health care delivery analysis</measure>
    <time_frame>3 months</time_frame>
    <description>Reporting the mean numbers of regular dental treatment visits and general anesthesia treatment in various subgroups of participants</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tooth loss in institutionalised participants</measure>
    <time_frame>3 months</time_frame>
    <description>Comparison of proportions of permanent teeth extractions as calculated as T fraction in DMFT index between institutionalised and non institutionalised participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tooth loss in general anaesthesia</measure>
    <time_frame>6 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <enrollment type="Anticipated">52</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <condition>Autism</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Oral care delivery analysis in participants with ASD</intervention_name>
    <description>The analysis of oral health status, tooth loss, oral rehabilitation, characteristics of routine dental treatment and treatment in general anaesthesia in persons with ASD</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants with ASD treated at the Dental Clinic of Vojvodina during 5 years observation&#xD;
        period&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of a autism spectrum disorder not confirmed by a physician&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Bojan B Petrovic, PhD</last_name>
    <phone>+38163342639</phone>
    <email>bojan.petrovic@mf.uns.ac.rs</email>
  </overall_contact>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 2, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>March 12, 2019</last_update_submitted>
  <last_update_submitted_qc>March 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Novi Sad</investigator_affiliation>
    <investigator_full_name>Bojan Petrovic</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>oral health</keyword>
  <keyword>dental care</keyword>
  <keyword>general anaesthesia</keyword>
  <keyword>tooth loss</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
    <mesh_term>Child Development Disorders, Pervasive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03830541
org study id: 01789/2019
nct id: NCT03830541
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Retrospective
measure: Oral Health Status as measured by number of subjects with missing teeth
time frame: 3 months
description: 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.
measure: Oral Health Status as measured by untreated dental decay
time frame: 6months
description: 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
measure: Oral health care delivery analysis
time frame: 3 months
description: Reporting the mean numbers of regular dental treatment visits and general anesthesia treatment in various subgroups of participants
measure: Tooth loss in institutionalised participants
time frame: 3 months
description: Comparison of proportions of permanent teeth extractions as calculated as T fraction in DMFT index between institutionalised and non institutionalised participants
measure: Tooth loss in general anaesthesia
time frame: 6 months
description: 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
intervention type: Other
intervention name: Oral care delivery analysis in participants with ASD
description: The analysis of oral health status, tooth loss, oral rehabilitation, characteristics of routine dental treatment and treatment in general anaesthesia in persons with ASD
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 80 Years
healthy volunteers: No
last name: Bojan B Petrovic, PhD
phone: +38163342639
email: bojan.petrovic@mf.uns.ac.rs
responsible party type: Principal Investigator
investigator affiliation: University of Novi Sad
investigator full name: Bojan Petrovic
investigator title: Principal Investigator
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
mesh term: Child Development Disorders, Pervasive
sharing ipd: No