<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/NCT04448093</url>
  </required_header>
  <id_info>
    <org_study_id>Hemodialysis</org_study_id>
    <nct_id>NCT04448093</nct_id>
  </id_info>
  <brief_title>Relationship Between Quality of Life, Self-image and Oral Health in Patients Undergoing Hemodialysis</brief_title>
  <official_title>Relationship Between Quality of Life, Self-image and Oral Health in Patients Undergoing Hemodialysis: A Comparative Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of São Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of São Paulo</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 objective of this work will be to conduct a controlled clinical trial to assess whether&#xD;
      the dental treatment of adequacy of the oral environment is capable of generating improvement&#xD;
      in the quality of life and self-esteem, comparing the results of patients on hemodialysis who&#xD;
      received treatment with others who did not receive treatment .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After selecting the sample, patients will undergo an oral examination performed by a dental&#xD;
      surgeon, in which they will be evaluated for the presence of lesions in the oral mucosa,&#xD;
      periodontal conditions through simplified periodontal record - PSR, oral hygiene index,&#xD;
      caries and lack of teeth - DMFT, if they need treatment and the situation of the prosthesis,&#xD;
      if they use them, the data being recorded in a specific medical record. Subsequently,&#xD;
      intervention will be performed in the group that received the treatment (intervention group).&#xD;
      The treatment will consist of the adequacy of the oral environment in patients with teeth and&#xD;
      evaluation of the mucosa and prostheses for edentulous patients.&#xD;
&#xD;
      The service will take place at the UFVJM Surgery and Periodontics Clinic, on previously&#xD;
      scheduled days and times. About 5 to 10 days before treatment, patients answered&#xD;
      questionnaires about socioeconomic characterization, self-esteem and quality of life. The&#xD;
      therapeutic protocol followed during the service will be the one proposed by Quirynen (1995)&#xD;
      [22], in which the debridement of the entire mouth is recommended in a single 45-minute&#xD;
      session. After removing the supra and subgingival biofilm, the patient will be instructed to&#xD;
      use mouthwashes with 15 ml of 0.12% chlorhexidine gluconate, for one minute, twice a day,&#xD;
      thirty minutes after brushing, for seven days. In this phase, emergency extractions,&#xD;
      restoration of restorations and cavity closure with glass ionomer cement and resins in the&#xD;
      anterior teeth will also be performed, in order to adapt the oral environment in minimal&#xD;
      interventions, considering the patient's systemic state.&#xD;
&#xD;
      All patients who have at least 1 tooth, healthy or not, will be considered dentate. Toothless&#xD;
      patients will receive guidance on oral hygiene and prostheses, if used, and will also use&#xD;
      mouthwash with 0.12% chlorhexidine gluconate for the same period. Group participants who were&#xD;
      not submitted to the intervention (control group), received the same initial assessment and&#xD;
      answered the same questionnaires, but will not be treated at that time. After 45 days from&#xD;
      the end of the dental treatment, everyone will be reassessed, went through oral hygiene&#xD;
      instructions again and answered the questionnaires, the questions being directed to the&#xD;
      patient's perception in the last 45 days after treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2014</start_date>
  <completion_date type="Actual">December 20, 2019</completion_date>
  <primary_completion_date type="Actual">August 29, 2015</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Intervention group and control group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dental treatment</measure>
    <time_frame>6 years</time_frame>
    <description>Comparison of quality of life and self-esteem results of patients who underwent dental treatment with others who did not.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">121</enrollment>
  <condition>Patients Undergoing Hemodialysis</condition>
  <arm_group>
    <arm_group_label>Treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treated group (53) that answered quality of life questionnaires before, after and with 45 days of treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Untreated group (68) that answered quality of life questionnaires before, after and with 45 days of treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>dental treatment</intervention_name>
    <description>Dental treatment of adequacy of oral environment and assessment of quality of life and self-esteem through questionnaires comparing a group that received treatment with another that did not.</description>
    <arm_group_label>Treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients over 18 years&#xD;
&#xD;
          -  submitted to hemodialysis&#xD;
&#xD;
          -  agreed to participate voluntarily by invitation and sign an informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe anemia&#xD;
&#xD;
          -  uncontrolled systolic and diastolic blood pressure or greater than 180/110 mmHg&#xD;
&#xD;
          -  unstable angina, complex ventricular arrhythmias, severe metabolic disease&#xD;
&#xD;
          -  acute myocardial infarction less than a month&#xD;
&#xD;
          -  acute conditions, aortic aneurysm, severe aortic stenosis or respiratory impairment&#xD;
&#xD;
          -  neurological and / or musculoskeletal that contraindicate treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>86 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Periodontics Clinic, Department of Dentistry</name>
      <address>
        <city>Diamantina</city>
        <state>Minas Gerais</state>
        <zip>39100000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>March 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>June 23, 2020</last_update_submitted>
  <last_update_submitted_qc>June 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of São Paulo</investigator_affiliation>
    <investigator_full_name>Olga Flecha</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Quality of life</keyword>
  <keyword>Dentistry</keyword>
  <keyword>Renal dialysis</keyword>
  <keyword>Epidemiology</keyword>
  <keyword>Self-image</keyword>
  <!-- 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/NCT04448093
org study id: Hemodialysis
nct id: NCT04448093
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this work will be to conduct a controlled clinical trial to assess whether
      the dental treatment of adequacy of the oral environment is capable of generating improvement
      in the quality of life and self-esteem, comparing the results of patients on hemodialysis who
      received treatment with others who did not receive treatment .
After selecting the sample, patients will undergo an oral examination performed by a dental
      surgeon, in which they will be evaluated for the presence of lesions in the oral mucosa,
      periodontal conditions through simplified periodontal record - PSR, oral hygiene index,
      caries and lack of teeth - DMFT, if they need treatment and the situation of the prosthesis,
      if they use them, the data being recorded in a specific medical record. Subsequently,
      intervention will be performed in the group that received the treatment (intervention group).
      The treatment will consist of the adequacy of the oral environment in patients with teeth and
      evaluation of the mucosa and prostheses for edentulous patients.

      The service will take place at the UFVJM Surgery and Periodontics Clinic, on previously
      scheduled days and times. About 5 to 10 days before treatment, patients answered
      questionnaires about socioeconomic characterization, self-esteem and quality of life. The
      therapeutic protocol followed during the service will be the one proposed by Quirynen (1995)
      [22], in which the debridement of the entire mouth is recommended in a single 45-minute
      session. After removing the supra and subgingival biofilm, the patient will be instructed to
      use mouthwashes with 15 ml of 0.12% chlorhexidine gluconate, for one minute, twice a day,
      thirty minutes after brushing, for seven days. In this phase, emergency extractions,
      restoration of restorations and cavity closure with glass ionomer cement and resins in the
      anterior teeth will also be performed, in order to adapt the oral environment in minimal
      interventions, considering the patient's systemic state.

      All patients who have at least 1 tooth, healthy or not, will be considered dentate. Toothless
      patients will receive guidance on oral hygiene and prostheses, if used, and will also use
      mouthwash with 0.12% chlorhexidine gluconate for the same period. Group participants who were
      not submitted to the intervention (control group), received the same initial assessment and
      answered the same questionnaires, but will not be treated at that time. After 45 days from
      the end of the dental treatment, everyone will be reassessed, went through oral hygiene
      instructions again and answered the questionnaires, the questions being directed to the
      patient's perception in the last 45 days after treatment.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Intervention group and control group.
primary purpose: Treatment
masking: None (Open Label)
measure: Dental treatment
time frame: 6 years
description: Comparison of quality of life and self-esteem results of patients who underwent dental treatment with others who did not.
arm group label: Treatment group
arm group type: Experimental
description: Treated group (53) that answered quality of life questionnaires before, after and with 45 days of treatment.
arm group label: Group control
arm group type: No Intervention
description: Untreated group (68) that answered quality of life questionnaires before, after and with 45 days of treatment.
intervention type: Procedure
intervention name: dental treatment
description: Dental treatment of adequacy of oral environment and assessment of quality of life and self-esteem through questionnaires comparing a group that received treatment with another that did not.
arm group label: Treatment group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 86 Years
healthy volunteers: No
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of São Paulo
investigator full name: Olga Flecha
investigator title: Principal Investigator