<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/NCT03283514</url>
  </required_header>
  <id_info>
    <org_study_id>01</org_study_id>
    <nct_id>NCT03283514</nct_id>
  </id_info>
  <brief_title>Esthetic Expectations of Edentulous Patients Followed in a French Dental Clinic</brief_title>
  <official_title>Esthetic Expectations of Edentulous Patients Followed in a French Dental Clinic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hôpital Rothschild</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hôpital Rothschild</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Esthetic is a major factor in complete denture (CD) success. Patient involvement in esthetic&#xD;
      project plays a crucial role in denture acceptance and patient satisfaction. Historically,&#xD;
      teeth choice and arrangement were made according to Frush and Ficher's recommendations&#xD;
      focusing on natural looking of esthetics. Dentists may also propose to restore the dentate&#xD;
      state looking for denture when preextraction data are available. Recently, a patient-centered&#xD;
      approach based on attractivity has been proposed and may lead to in an appearance&#xD;
      transcending the laws of nature.&#xD;
&#xD;
      The aim of the present study was to investigate actual denture esthetic expectations in a&#xD;
      French edentate population followed in a university dental clinic (Rothschild Hospital ,&#xD;
      AP-HP).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inclusion criteria : being currently edentulous within at least within the maxillary arch,&#xD;
      literate French speakers, willing and able to complete the survey in a single sitting.&#xD;
      Clinical data collection was made by a unique examiner and concerned length of edentulism,&#xD;
      antagonist arch, existence of preextraction data, smile attractivity opinion. The respondents&#xD;
      completed a questionnaire identifying their age, sex, educational and income level. Patients&#xD;
      were also asked for their denture look preference among 4 esthetic projects: 1) restoring&#xD;
      pre-extraction (dentate) looking, 2) restoring actual denture looking, 3) creating natural&#xD;
      looking, 4) creating perfect looking, 5) no opinion. Each project was explained similarly by&#xD;
      the same examiner. Statistical analysis using a Pearson Chi-squared test at a 0.05 level of&#xD;
      significance was conducted for associations between esthetic projects preference and tested&#xD;
      variables.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2016</start_date>
  <completion_date type="Actual">September 1, 2017</completion_date>
  <primary_completion_date type="Actual">September 1, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>esthetic preferred project</measure>
    <time_frame>Esthetic expectation evaluated at date of inclusion</time_frame>
    <description>Patients were asked for their denture-looking expectations among 4 esthetic projects: 1) restoring pre-extraction dentate looking, 2) restoring actual denture looking, 3) creating natural looking, 4) creating perfect looking, 5) no opinion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>age</measure>
    <time_frame>evaluated at date of inclusion</time_frame>
    <description>Respondents completed a questionnaire identifying their age (in years)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>gender</measure>
    <time_frame>evaluated at date of inclusion</time_frame>
    <description>Respondents completed a questionnaire identifying their gender (man or woman)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>educational level</measure>
    <time_frame>evaluated at date of inclusion</time_frame>
    <description>Respondents completed a questionnaire identifying their educational level : last degree (no degree at al, French General Certificate Secondary Education, High School Diploma, Vocational Training Certificate taken at Secondary School, university degree)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>month income level,</measure>
    <time_frame>evaluated at date of inclusion</time_frame>
    <description>Respondents completed a questionnaire identifying their income level each month : in euros</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length of edentulism,</measure>
    <time_frame>evaluated at date of inclusion</time_frame>
    <description>Respondents completed a questionnaire identifying the duration of edentulism (in years)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>smile attractivity opinion</measure>
    <time_frame>evaluated at date of inclusion</time_frame>
    <description>Respondents completed a questionnaire identifying their smile attractivity opinion Respondents completed a questionnaire identifying the most attractive smile among 4 esthetic situations : preextraction-looking smile, denture-like smile, natural-like smile, perfect smile.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>preextraction data available</measure>
    <time_frame>evaluated at date of inclusion</time_frame>
    <description>Respondents completed a questionnaire identifying the existence of preextraction data available (available or not available)</description>
  </secondary_outcome>
  <enrollment type="Actual">42</enrollment>
  <condition>Complete Edentulism</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Complete denture</intervention_name>
    <description>questionnaire</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Totally edentulous subjects (20 women, 22 men, mena aged: 67.9 ± 12.2 years) attending&#xD;
        maxillary CD in the department of prosthodontics of the Hopital Rothschild (AP-HP) are&#xD;
        concerned by recruitment and are proposed to participate.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria : Currently edentulous maxillary arch, literate French speakers, willing&#xD;
        and able to complete the survey in a single sitting. Inclusion Criteria:&#xD;
&#xD;
        Exclusion Criteria: Aged under 18 years.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 9, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>September 12, 2017</last_update_submitted>
  <last_update_submitted_qc>September 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hôpital Rothschild</investigator_affiliation>
    <investigator_full_name>Dr Braud Adeline</investigator_full_name>
    <investigator_title>maitre de conférences -praticien hospitalier</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mouth, Edentulous</mesh_term>
  </condition_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/NCT03283514
org study id: 01
nct id: NCT03283514
lead sponsor: 
has dmc: No
Esthetic is a major factor in complete denture (CD) success. Patient involvement in esthetic
      project plays a crucial role in denture acceptance and patient satisfaction. Historically,
      teeth choice and arrangement were made according to Frush and Ficher's recommendations
      focusing on natural looking of esthetics. Dentists may also propose to restore the dentate
      state looking for denture when preextraction data are available. Recently, a patient-centered
      approach based on attractivity has been proposed and may lead to in an appearance
      transcending the laws of nature.

      The aim of the present study was to investigate actual denture esthetic expectations in a
      French edentate population followed in a university dental clinic (Rothschild Hospital ,
      AP-HP).
Inclusion criteria : being currently edentulous within at least within the maxillary arch,
      literate French speakers, willing and able to complete the survey in a single sitting.
      Clinical data collection was made by a unique examiner and concerned length of edentulism,
      antagonist arch, existence of preextraction data, smile attractivity opinion. The respondents
      completed a questionnaire identifying their age, sex, educational and income level. Patients
      were also asked for their denture look preference among 4 esthetic projects: 1) restoring
      pre-extraction (dentate) looking, 2) restoring actual denture looking, 3) creating natural
      looking, 4) creating perfect looking, 5) no opinion. Each project was explained similarly by
      the same examiner. Statistical analysis using a Pearson Chi-squared test at a 0.05 level of
      significance was conducted for associations between esthetic projects preference and tested
      variables.
observational model: Other
time perspective: Prospective
measure: esthetic preferred project
time frame: Esthetic expectation evaluated at date of inclusion
description: Patients were asked for their denture-looking expectations among 4 esthetic projects: 1) restoring pre-extraction dentate looking, 2) restoring actual denture looking, 3) creating natural looking, 4) creating perfect looking, 5) no opinion.
measure: age
time frame: evaluated at date of inclusion
description: Respondents completed a questionnaire identifying their age (in years)
measure: gender
time frame: evaluated at date of inclusion
description: Respondents completed a questionnaire identifying their gender (man or woman)
measure: educational level
time frame: evaluated at date of inclusion
description: Respondents completed a questionnaire identifying their educational level : last degree (no degree at al, French General Certificate Secondary Education, High School Diploma, Vocational Training Certificate taken at Secondary School, university degree)
measure: month income level,
time frame: evaluated at date of inclusion
description: Respondents completed a questionnaire identifying their income level each month : in euros
measure: length of edentulism,
time frame: evaluated at date of inclusion
description: Respondents completed a questionnaire identifying the duration of edentulism (in years)
measure: smile attractivity opinion
time frame: evaluated at date of inclusion
description: Respondents completed a questionnaire identifying their smile attractivity opinion Respondents completed a questionnaire identifying the most attractive smile among 4 esthetic situations : preextraction-looking smile, denture-like smile, natural-like smile, perfect smile.
measure: preextraction data available
time frame: evaluated at date of inclusion
description: Respondents completed a questionnaire identifying the existence of preextraction data available (available or not available)
intervention type: Other
intervention name: Complete denture
description: questionnaire
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Hôpital Rothschild
investigator full name: Dr Braud Adeline
investigator title: maitre de conférences -praticien hospitalier
mesh term: Mouth, Edentulous
sharing ipd: Undecided