<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/NCT04407520</url>
  </required_header>
  <id_info>
    <org_study_id>Survival-Disabled</org_study_id>
    <secondary_id>15/1/18</secondary_id>
    <nct_id>NCT04407520</nct_id>
  </id_info>
  <brief_title>Retrospective Database Study: Survival of Direct Composite Restorations Placed Under General Anesthesia in Adult Patients With Intellectual and/or Physical Disabilities and Risk Factors for Repeated Dental Treatment in General Anesthesia</brief_title>
  <official_title>Survival of Direct Composite Restorations Placed Under General Anesthesia in Adult Patients With Intellectual and/or Physical Disabilities and Risk Factors for Repeated Dental Treatment in General Anesthesia of Adult Patients With Intellectual and/or Physical Disabilities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Göttingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Göttingen</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>
      The aim of this study is to assess the survival of direct anterior and/or posterior composite&#xD;
      restoration placed in general anesthesia in permanent teeth of adult patients with&#xD;
      intellectual and/or physical disabilities. Further aim is to identify potential risk factors&#xD;
      predicting repeated dental treatment under general anesthesia.&#xD;
&#xD;
      Survival of composite restorations placed under general anesthesia in adult patients with&#xD;
      intellectual and/or physical disabilities between 2011 and 2019 will be retrospectively&#xD;
      analysed. Failure is defined as the need for replacement of at least one surface of the&#xD;
      original restoration or extraction of the tooth. Individual-, tooth- and restoration-related&#xD;
      factors are obtained from digital and paper-based dental records. Mean annual failure rates&#xD;
      (mAFR) and median survival time will be calculated (Kaplan-Meier statistics). The effect of&#xD;
      potential risk factors on failure will be tested using univariate log-rank tests and&#xD;
      multivariate Cox-regression analysis.&#xD;
&#xD;
      Adult patients with intellectual and/or physical disabilities who received dental treatment&#xD;
      under general anesthesia between 2011 and 2017 will be retrospectively analyzed. Demographic,&#xD;
      anamnestic, oral health and treatment factors will be obtained from digital and paper-based&#xD;
      dental records. Duration of intervals without a subsequent dental treatment under general&#xD;
      anesthesia will be assessed using Kaplan-Meier statistics. Potential predictive factors will&#xD;
      be tested using log-rank tests and multi-variate Cox-regression analysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      No patient treatment is associated with the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 21, 2011</start_date>
  <completion_date type="Actual">May 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 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>Failure of restoration placed under general anesthesia</measure>
    <time_frame>2011-2019</time_frame>
    <description>Failure is defined as the need for replacement of at least one surface of the original restoration or extraction of the tooth.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Repeated dental treatment under general anesthesia</measure>
    <time_frame>2011-2017</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">101</enrollment>
  <condition>Intellectual and/or Physical Disabilities</condition>
  <condition>Dental Treatment Under General Anesthesia</condition>
  <arm_group>
    <arm_group_label>Adult patients with intellectual and/or physical disabilities</arm_group_label>
    <description>Adult patients with intellectual and/or physical disabilities requiring dental treatment under general anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No patient treatment is associated with the study</intervention_name>
    <description>No patient treatment is associated with the study.</description>
    <arm_group_label>Adult patients with intellectual and/or physical disabilities</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with intellectual and/or physical disabilities and need for dental treatment&#xD;
        under general anesthesia.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients with intellectual and/or physical disabilities that were treated under&#xD;
             general anesthesia in the Department of Preventive Dentistry, Periodontology and&#xD;
             Cariology between January 2011 and December 2019&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <results_reference>
    <citation>Maes MS, Kanzow P, Hrasky V, Wiegand A. Survival of direct composite restorations placed under general anesthesia in adult patients with intellectual and/or physical disabilities. Clin Oral Investig. 2021 Jul;25(7):4563-4569. doi: 10.1007/s00784-020-03770-y. Epub 2021 Jan 15.</citation>
    <PMID>33449193</PMID>
  </results_reference>
  <results_reference>
    <citation>Maes MS, Kanzow P, Biermann J, Leha A, Hrasky V, Wiegand A. Risk factors for repeated general anesthesia for dental treatment of adult patients with intellectual and/or physical disabilities. Clin Oral Investig. 2022 Feb;26(2):1695-1700. doi: 10.1007/s00784-021-04142-w. Epub 2021 Aug 25.</citation>
    <PMID>34432139</PMID>
  </results_reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>August 26, 2021</last_update_submitted>
  <last_update_submitted_qc>August 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Center Goettingen</investigator_affiliation>
    <investigator_full_name>Philipp Kanzow, PD Dr. med. dent., Dr. rer. medic.</investigator_full_name>
    <investigator_title>Senior Dental Practitioner</investigator_title>
  </responsible_party>
  <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/NCT04407520
org study id: Survival-Disabled
secondary id: 15/1/18
nct id: NCT04407520
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to assess the survival of direct anterior and/or posterior composite
      restoration placed in general anesthesia in permanent teeth of adult patients with
      intellectual and/or physical disabilities. Further aim is to identify potential risk factors
      predicting repeated dental treatment under general anesthesia.

      Survival of composite restorations placed under general anesthesia in adult patients with
      intellectual and/or physical disabilities between 2011 and 2019 will be retrospectively
      analysed. Failure is defined as the need for replacement of at least one surface of the
      original restoration or extraction of the tooth. Individual-, tooth- and restoration-related
      factors are obtained from digital and paper-based dental records. Mean annual failure rates
      (mAFR) and median survival time will be calculated (Kaplan-Meier statistics). The effect of
      potential risk factors on failure will be tested using univariate log-rank tests and
      multivariate Cox-regression analysis.

      Adult patients with intellectual and/or physical disabilities who received dental treatment
      under general anesthesia between 2011 and 2017 will be retrospectively analyzed. Demographic,
      anamnestic, oral health and treatment factors will be obtained from digital and paper-based
      dental records. Duration of intervals without a subsequent dental treatment under general
      anesthesia will be assessed using Kaplan-Meier statistics. Potential predictive factors will
      be tested using log-rank tests and multi-variate Cox-regression analysis.
No patient treatment is associated with the study.
observational model: Cohort
time perspective: Retrospective
measure: Failure of restoration placed under general anesthesia
time frame: 2011-2019
description: Failure is defined as the need for replacement of at least one surface of the original restoration or extraction of the tooth.
measure: Repeated dental treatment under general anesthesia
time frame: 2011-2017
arm group label: Adult patients with intellectual and/or physical disabilities
description: Adult patients with intellectual and/or physical disabilities requiring dental treatment under general anesthesia
intervention type: Other
intervention name: No patient treatment is associated with the study
description: No patient treatment is associated with the study.
arm group label: Adult patients with intellectual and/or physical disabilities
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
citation: Maes MS, Kanzow P, Hrasky V, Wiegand A. Survival of direct composite restorations placed under general anesthesia in adult patients with intellectual and/or physical disabilities. Clin Oral Investig. 2021 Jul;25(7):4563-4569. doi: 10.1007/s00784-020-03770-y. Epub 2021 Jan 15.
PMID: 33449193
citation: Maes MS, Kanzow P, Biermann J, Leha A, Hrasky V, Wiegand A. Risk factors for repeated general anesthesia for dental treatment of adult patients with intellectual and/or physical disabilities. Clin Oral Investig. 2022 Feb;26(2):1695-1700. doi: 10.1007/s00784-021-04142-w. Epub 2021 Aug 25.
PMID: 34432139
responsible party type: Principal Investigator
investigator affiliation: University Medical Center Goettingen
investigator full name: Philipp Kanzow, PD Dr. med. dent., Dr. rer. medic.
investigator title: Senior Dental Practitioner
sharing ipd: No