<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/NCT01679821</url>
  </required_header>
  <id_info>
    <org_study_id>538/2010-CEP</org_study_id>
    <nct_id>NCT01679821</nct_id>
  </id_info>
  <brief_title>Prevalence of Signs and Symptoms of TMD in Patients Wearing Double Complete Dentures, RPD and in Dentistry Students.</brief_title>
  <official_title>Prevalence of Signs and Symptoms of Temporomandibular Disorders (TMD) in Patients Wearing Double Complete Dentures, Removable Partial Dentures and Dentistry Students at State University of West of Paraná - UNIOESTE</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Estadual do Oeste do Paraná</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Estadual do Oeste do Paraná</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It was proposed in this study to evaluate the prevalence of TMD signs and symptoms in State&#xD;
      University of West of Parana's dental students with natural dentition, in patients with&#xD;
      removable partial dentures and double complete dentures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Temporomandibular Disorder (TMD) has a high prevalence among the population. Objectives:&#xD;
      To evaluate the prevalence of signs and symptoms of TMD. Methodology: 210 randomly selected&#xD;
      individuals were evaluated, being divided into three groups with seventy individuals each:&#xD;
      Group 1 - dental students with natural dentition. Group 2 - patients with removable partial&#xD;
      dentures. And Group 3 - patients with double complete dentures. The questionnaire of the&#xD;
      American Academy of Orofacial Pain for triage was employed, then, clinical evaluation was&#xD;
      carried out.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2010</start_date>
  <completion_date type="Actual">August 2011</completion_date>
  <primary_completion_date type="Actual">March 2011</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of the prevalence of signs and symptoms of temporomandibular disorders in patients with removable partial dentures, complete double dentures and toothed.</measure>
    <time_frame>5 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>questionnaire for selection of orofacial pain and temporomandibular disorders recommended by the American Academy of Orofacial Pain</measure>
    <time_frame>5 monts</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Clinical examination</measure>
    <time_frame>5 months</time_frame>
    <description>A clinical examination, which was divided into parts, namely: identification and analysis; part of the Axis I of RDC/TMD - Research Criteria for Temporomandibular Disorders; muscle palpation; and for patients with dentures, the history and clinical evaluation of them</description>
  </other_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">210</enrollment>
  <condition>Temporomandibular Joint Disorders</condition>
  <arm_group>
    <arm_group_label>Dental students</arm_group_label>
    <description>Seventy dental students of State University of West of Paraná - UNIOESTE. Students in orthodontic treatment or with less than one year after the end of orthodontic treatment were excluded from the research. A questionnaire and a clinical examination were employed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Removable partial denture</arm_group_label>
    <description>Seventy patients treated at the UNIOESTE Dental Clinic that wore removable partial denture (partially edentulous). Patients wearing a complete denture in one maxillary and a removable partial denture in another maxillary were not included in the research. A questionnaire and a clinical examination were employed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Double complete denture</arm_group_label>
    <description>Seventy patients with double complete dentures treated in Center for Dental Specialties of Cascavel, Paraná, Brazil. Patients wearing just one complete denture were not included in the research. A questionnaire and a clinical examination were employed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>A questionnaire and a clinical examination</intervention_name>
    <description>Seventy dental students of State University of West of Paraná - UNIOESTE, seventy patients treated at the UNIOESTE Dental Clinic that wore removable partial denture (partially edentulous) and seventy patients with double complete dentures treated in Center for Dental Specialties of Cascavel, Paraná, Brazil. Students in orthodontic treatment or with less than one year after the end of orthodontic treatment were excluded from the research. Patients wearing a complete denture in one maxillary and a removable partial denture in another maxillary, and patients wearing just one complete denture were not included in the research.</description>
    <arm_group_label>Dental students</arm_group_label>
    <arm_group_label>Double complete denture</arm_group_label>
    <arm_group_label>Removable partial denture</arm_group_label>
  </intervention>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      The sample consisted of 210 individuals, aged 19-90 years (average 44.5 years) of both&#xD;
      genders, divided into 3 groups:&#xD;
&#xD;
      Group 1 - seventy dental students of State University of West of Paraná - UNIOESTE; Group 2 -&#xD;
      seventy patients treated at the UNIOESTE Dental Clinic that wore removable partial denture&#xD;
      (partially edentulous); Group 3 - seventy patients with double complete dentures treated in&#xD;
      Center for Dental Specialties of Cascavel - PR.&#xD;
&#xD;
      Students in orthodontic treatment or with less than one year after the end of orthodontic&#xD;
      treatment were excluded from the research. Patients wearing a complete denture in one&#xD;
      maxillary and a removable partial denture in another maxillary, and patients wearing just one&#xD;
      complete denture were not included in the research.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Seventy dental students of State University of West of Paraná - UNIOESTE, seventy patients&#xD;
        treated at the UNIOESTE Dental Clinic that wore removable partial denture (partially&#xD;
        edentulous) and seventy patients with double complete dentures treated in Center for Dental&#xD;
        Specialties of Cascavel, Paraná, Brazil.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Patients wearing double complete denture, patients wearing just removable partial denture&#xD;
        and dentate students.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Students in orthodontic treatment or with less than one year after the end of orthodontic&#xD;
        treatment were excluded from the research.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maristela Pezzini, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Estadual do Oeste do Paraná</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Thaisa Bordin, Student</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Estadual do Oeste do Paraná</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidade Estadual do Oeste do Paraná</name>
      <address>
        <city>Cascavel</city>
        <state>Paraná</state>
        <zip>85819110</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 1, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>September 5, 2012</last_update_submitted>
  <last_update_submitted_qc>September 5, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 6, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Estadual do Oeste do Paraná</investigator_affiliation>
    <investigator_full_name>Maristela Maria Galina Pezzini</investigator_full_name>
    <investigator_title>Associate Professor, Department of Occlusion, State University of West of Paraná - UNIOESTE, Cascavel, PR, Brazil</investigator_title>
  </responsible_party>
  <keyword>Temporomandibular disorders.</keyword>
  <keyword>Dental prosthesis.</keyword>
  <keyword>Dental students</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Temporomandibular Joint Disorders</mesh_term>
    <mesh_term>Temporomandibular Joint Dysfunction Syndrome</mesh_term>
    <mesh_term>Joint Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT01679821
org study id: 538/2010-CEP
nct id: NCT01679821
lead sponsor: 
has dmc: Yes
It was proposed in this study to evaluate the prevalence of TMD signs and symptoms in State
      University of West of Parana's dental students with natural dentition, in patients with
      removable partial dentures and double complete dentures.
The Temporomandibular Disorder (TMD) has a high prevalence among the population. Objectives:
      To evaluate the prevalence of signs and symptoms of TMD. Methodology: 210 randomly selected
      individuals were evaluated, being divided into three groups with seventy individuals each:
      Group 1 - dental students with natural dentition. Group 2 - patients with removable partial
      dentures. And Group 3 - patients with double complete dentures. The questionnaire of the
      American Academy of Orofacial Pain for triage was employed, then, clinical evaluation was
      carried out.
observational model: Cohort
time perspective: Cross-Sectional
measure: Assessment of the prevalence of signs and symptoms of temporomandibular disorders in patients with removable partial dentures, complete double dentures and toothed.
time frame: 5 months
measure: questionnaire for selection of orofacial pain and temporomandibular disorders recommended by the American Academy of Orofacial Pain
time frame: 5 monts
measure: Clinical examination
time frame: 5 months
description: A clinical examination, which was divided into parts, namely: identification and analysis; part of the Axis I of RDC/TMD - Research Criteria for Temporomandibular Disorders; muscle palpation; and for patients with dentures, the history and clinical evaluation of them
arm group label: Dental students
description: Seventy dental students of State University of West of Paraná - UNIOESTE. Students in orthodontic treatment or with less than one year after the end of orthodontic treatment were excluded from the research. A questionnaire and a clinical examination were employed.
arm group label: Removable partial denture
description: Seventy patients treated at the UNIOESTE Dental Clinic that wore removable partial denture (partially edentulous). Patients wearing a complete denture in one maxillary and a removable partial denture in another maxillary were not included in the research. A questionnaire and a clinical examination were employed.
arm group label: Double complete denture
description: Seventy patients with double complete dentures treated in Center for Dental Specialties of Cascavel, Paraná, Brazil. Patients wearing just one complete denture were not included in the research. A questionnaire and a clinical examination were employed.
intervention type: Other
intervention name: A questionnaire and a clinical examination
description: Seventy dental students of State University of West of Paraná - UNIOESTE, seventy patients treated at the UNIOESTE Dental Clinic that wore removable partial denture (partially edentulous) and seventy patients with double complete dentures treated in Center for Dental Specialties of Cascavel, Paraná, Brazil. Students in orthodontic treatment or with less than one year after the end of orthodontic treatment were excluded from the research. Patients wearing a complete denture in one maxillary and a removable partial denture in another maxillary, and patients wearing just one complete denture were not included in the research.
arm group label: Dental students
arm group label: Double complete denture
arm group label: Removable partial denture
The sample consisted of 210 individuals, aged 19-90 years (average 44.5 years) of both
      genders, divided into 3 groups:

      Group 1 - seventy dental students of State University of West of Paraná - UNIOESTE; Group 2 -
      seventy patients treated at the UNIOESTE Dental Clinic that wore removable partial denture
      (partially edentulous); Group 3 - seventy patients with double complete dentures treated in
      Center for Dental Specialties of Cascavel - PR.

      Students in orthodontic treatment or with less than one year after the end of orthodontic
      treatment were excluded from the research. Patients wearing a complete denture in one
      maxillary and a removable partial denture in another maxillary, and patients wearing just one
      complete denture were not included in the research.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Maristela Pezzini, Professor
role: Principal Investigator
affiliation: Universidade Estadual do Oeste do Paraná
last name: Thaisa Bordin, Student
role: Principal Investigator
affiliation: Universidade Estadual do Oeste do Paraná
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Estadual do Oeste do Paraná
investigator full name: Maristela Maria Galina Pezzini
investigator title: Associate Professor, Department of Occlusion, State University of West of Paraná - UNIOESTE, Cascavel, PR, Brazil
mesh term: Temporomandibular Joint Disorders
mesh term: Temporomandibular Joint Dysfunction Syndrome
mesh term: Joint Diseases