<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/NCT03823976</url>
  </required_header>
  <id_info>
    <org_study_id>01454/2018</org_study_id>
    <nct_id>NCT03823976</nct_id>
  </id_info>
  <brief_title>Dental Treatment and Oral Rehabilitation for Adult Individuals With Intellectual Disability in General Anaesthesia</brief_title>
  <acronym>DTADGA</acronym>
  <official_title>A Pattern of Dental Treatment and Oral Rehabilitation for Adult Individuals With Intellectual Disability in General Anaesthesia</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>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the types of dental procedures performed in general anaesthesia for&#xD;
      adult persons with intellectual disability, as well as factors affecting the decision to&#xD;
      perform the dental treatment in general anaesthesia, factors contributing to tooth loss and&#xD;
      possibilities to perform oral rehabilitation procedures&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Oral diseases are not life threatening and dental procedures usually do not pose significant&#xD;
      risk to a patient. In situation where a patient does not tolerate dental treatment, and&#xD;
      consequently general anaethesia (GA) is used, an intellectually disabled (ID) patient with a&#xD;
      condition that is routinely managed in the general population is exposed to significantly&#xD;
      higher medical risk. Quality of oral health care delivery for adults with ID is considered&#xD;
      inadequate and in need of constant improvement. Therefore, the present study aims to analyse&#xD;
      the type of dental treatment performed in GA and factors affecting the treatment. By its&#xD;
      design this is an observational, epidemiological, retrospective study. A representative&#xD;
      sample of the target population is realised by the assessment of approximately n=250 ID&#xD;
      adults treated at the Dental Clinic of Vojvodina. A number of parameters such as severity of&#xD;
      ID, the presence of concomitant conditions, living arrangements, medical diagnoses, physical&#xD;
      status according to the American Society of Anesthesiologists' classification (ASA score),&#xD;
      history of previous surgical/GA treatments and injuries/trauma, frequency of dental visits,&#xD;
      procedures that were conducted in GA and during routine dental treatment (RDT), dental status&#xD;
      including DMFT (decay, missed, filled teeth index) and total number of extracted teeth and&#xD;
      data about oral rehabilitation.The use of GA emphasizes the inequalities in persons with ID,&#xD;
      since it is always more radical compared to RDT. It is a frequent occurrence that with the&#xD;
      use of GA only prevention of complications and pain relief are accomplished, resulting in a&#xD;
      multiple teeth extractions. This approach inevitably leads to further dysfunctions in&#xD;
      cranio-facial system, affecting all aspects of everyday life in persons with ID.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 20, 2019</start_date>
  <completion_date type="Anticipated">June 20, 2019</completion_date>
  <primary_completion_date type="Anticipated">April 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>Tooth loss analysis calculated as T fraction in DMFT teeth after the procedure</measure>
    <time_frame>3 months</time_frame>
    <description>The analysis of the mean number of extracted teeth per patient during dental procedure in general anaesthesia. Correlations (odds-ratios) between the level of ID, the presence of comorbidities, institutionalisation and tooth loss</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oral rehabilitation analysis calculated as care index (CI), defined as the number of restored teeth as a fraction of the total number of decayed (D), missing (M) and filled (F) teeth (CI= F/DMF × 100).</measure>
    <time_frame>6months</time_frame>
    <description>The analysis of oral rehabilitation procedures performed during general anaesthesia.Correlations (odds-ratios) between the level of ID, the presence of comorbidities, institutionalisation and the level of CI</description>
  </primary_outcome>
  <enrollment type="Anticipated">274</enrollment>
  <condition>Intellectual Disabilities (F70-F79)</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Types of the dental procedures in general anaesthesia</intervention_name>
    <description>Analysis of the mean number of preventive, prophylactic, therapeutic and rehabilitation procedures</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Study includes all patients older than 18 years that have been treated in general&#xD;
        anesthesia between 2008 and 2018 at the Dentistry Clinic of Vojvodina, Serbia. Study&#xD;
        gathered data from medical documentation of procedures which was obtained&#xD;
        patient's/parents'/caregivers' consent for.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants with ID older than 18 years at the time of treatment in GA&#xD;
&#xD;
          -  Participants who had at least one general anesthesia dental treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who had dental treatment in GA due to physical condition, without ID&#xD;
&#xD;
          -  Participants younger than 18,&#xD;
&#xD;
          -  Participants with ID who had never had treatment in GA.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bojan B Petrovic, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty of Medicine, Dental Clinic of Vojvodina</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bojan B Petrovic, PhD</last_name>
    <phone>+38163342639</phone>
    <email>bojan.petrovic@mf.uns.ac.rs</email>
  </overall_contact>
  <location>
    <facility>
      <name>Dental Clinic of Vojvodina</name>
      <address>
        <city>Novi Sad</city>
        <zip>21000</zip>
        <country>Serbia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bojan B Petrovic, PhD</last_name>
      <phone>+38121612222</phone>
      <phone_ext>17</phone_ext>
      <email>bojan.petrovic@mf.uns.ac.rs</email>
    </contact>
  </location>
  <location_countries>
    <country>Serbia</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 20, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 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>dental care</keyword>
  <keyword>oral rehabilitation</keyword>
  <keyword>general anaesthesia</keyword>
  <keyword>tooth loss</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intellectual Disability</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03823976
org study id: 01454/2018
nct id: NCT03823976
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the types of dental procedures performed in general anaesthesia for
      adult persons with intellectual disability, as well as factors affecting the decision to
      perform the dental treatment in general anaesthesia, factors contributing to tooth loss and
      possibilities to perform oral rehabilitation procedures
Oral diseases are not life threatening and dental procedures usually do not pose significant
      risk to a patient. In situation where a patient does not tolerate dental treatment, and
      consequently general anaethesia (GA) is used, an intellectually disabled (ID) patient with a
      condition that is routinely managed in the general population is exposed to significantly
      higher medical risk. Quality of oral health care delivery for adults with ID is considered
      inadequate and in need of constant improvement. Therefore, the present study aims to analyse
      the type of dental treatment performed in GA and factors affecting the treatment. By its
      design this is an observational, epidemiological, retrospective study. A representative
      sample of the target population is realised by the assessment of approximately n=250 ID
      adults treated at the Dental Clinic of Vojvodina. A number of parameters such as severity of
      ID, the presence of concomitant conditions, living arrangements, medical diagnoses, physical
      status according to the American Society of Anesthesiologists' classification (ASA score),
      history of previous surgical/GA treatments and injuries/trauma, frequency of dental visits,
      procedures that were conducted in GA and during routine dental treatment (RDT), dental status
      including DMFT (decay, missed, filled teeth index) and total number of extracted teeth and
      data about oral rehabilitation.The use of GA emphasizes the inequalities in persons with ID,
      since it is always more radical compared to RDT. It is a frequent occurrence that with the
      use of GA only prevention of complications and pain relief are accomplished, resulting in a
      multiple teeth extractions. This approach inevitably leads to further dysfunctions in
      cranio-facial system, affecting all aspects of everyday life in persons with ID.
observational model: Cohort
time perspective: Retrospective
measure: Tooth loss analysis calculated as T fraction in DMFT teeth after the procedure
time frame: 3 months
description: The analysis of the mean number of extracted teeth per patient during dental procedure in general anaesthesia. Correlations (odds-ratios) between the level of ID, the presence of comorbidities, institutionalisation and tooth loss
measure: Oral rehabilitation analysis calculated as care index (CI), defined as the number of restored teeth as a fraction of the total number of decayed (D), missing (M) and filled (F) teeth (CI= F/DMF × 100).
time frame: 6months
description: The analysis of oral rehabilitation procedures performed during general anaesthesia.Correlations (odds-ratios) between the level of ID, the presence of comorbidities, institutionalisation and the level of CI
intervention type: Other
intervention name: Types of the dental procedures in general anaesthesia
description: Analysis of the mean number of preventive, prophylactic, therapeutic and rehabilitation procedures
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bojan B Petrovic, PhD
role: Principal Investigator
affiliation: Faculty of Medicine, Dental Clinic of Vojvodina
last name: Bojan B Petrovic, PhD
phone: +38163342639
email: bojan.petrovic@mf.uns.ac.rs
facility: 
status: Recruiting
contact: 
country: Serbia
responsible party type: Principal Investigator
investigator affiliation: University of Novi Sad
investigator full name: Bojan Petrovic
investigator title: Principal Investigator
mesh term: Intellectual Disability
mesh term: Anesthetics
sharing ipd: Undecided