<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/NCT03753932</url>
  </required_header>
  <id_info>
    <org_study_id>FORSS-385261</org_study_id>
    <secondary_id>FORSS-341741</secondary_id>
    <secondary_id>FUTURUM-265981</secondary_id>
    <nct_id>NCT03753932</nct_id>
  </id_info>
  <brief_title>Impact of Fixed Dentures in Head and Neck Cancer (IMFDHAC)</brief_title>
  <acronym>IMFDHAC</acronym>
  <official_title>Patients With Head and Neck Cancer Treated by Radiotherapy: The Impact of Fixed Dentures on Wellbeing and Oral Health Related Quality of Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Jönköping County</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>School of Health Sciences, Jönköping University, Jönköping Sweden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Malmö University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Region Jönköping County</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 purpose of the multi centre study is to evaluate an intervention, which means that&#xD;
      patients undergoing radiotherapy for head and neck cancer will receive fixed dentures in&#xD;
      accordance with the Public Health Care fee system with regard to well-being and oral health&#xD;
      related quality of life.&#xD;
&#xD;
      Hypotheses: the intervention will improve oral health related quality of life, general&#xD;
      wellbeing, and nutrition in patients treated by radiotherapy, with or without combination of&#xD;
      chemotherapy or surgery against head and neck cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The oncological care is multidisciplinary. In the investigation phase for radiotherapy, the&#xD;
      Ear-Nose-Throat (ENT) physician refer the patient for a dental examination. Any dental&#xD;
      infections are treated to reduce the risk of radiation-related infections that may occur&#xD;
      after cancer treatment. This may mean that infected but symptom-free teeth, which the patient&#xD;
      experiences as healthy need to be removed. This prophylactic dental treatment is charged&#xD;
      according to the Public Health Care fee system.&#xD;
&#xD;
      The study will take place in one major and in four middle sized counties in Sweden. The&#xD;
      intervention will include 30 patients with head and neck cancer recruited from a Department&#xD;
      of Maxillofacial and Oral Surgery (the City of Jönköping, Jönköping County Council), and from&#xD;
      the Department of Orofacial Medicine (the City of Stockholm, Stockholm County Council).&#xD;
      Another 30 patients with the same disease will be matched controls recruited from another&#xD;
      Department of Maxillofacial and Oral Surgery (the City of Linköping, County Council of&#xD;
      Östergötland) and from five Departments of Orofacial Medicine (the Cities of Kalmar,&#xD;
      Oskarshamn, and Västervik, Kalmar County Council; the City of Växjö, Kronoberg County&#xD;
      Council).&#xD;
&#xD;
      The project consists of three sub-studies: A quantitative study; a qualitative study; and a&#xD;
      health economics study. About 30 patients will be included in the intervention group, as well&#xD;
      as about 30 matched control patients. Data collection will take place with questionnaires&#xD;
      (SF-36, EQ-5D, OHIP-14, GOHAI, JFLS-8, OAS) and interviews.&#xD;
&#xD;
      Patients recruited to the intervention group will be treated prosthodontically with removable&#xD;
      and later with fixed dentures, thus acting as their own controls.&#xD;
&#xD;
      If possible but not necessary, those controls may be prosthodontically rehabilitated with&#xD;
      temporary removable dentures.&#xD;
&#xD;
      The inclusion criteria are patients with head and neck tumours considered to receive&#xD;
      radiotherapy, with or without combination of chemotherapy or surgery, good oncological&#xD;
      prognosis at baseline. After referral from an ENT-specialist, those patients being diagnosed&#xD;
      with dental infections and therapy planned for dental extraction(s) will be included.&#xD;
&#xD;
      The following general exclusion criteria will be applied: any communication problems; any&#xD;
      comorbidity with poor prognosis; poor oncological prognosis at baseline; imminent risk of&#xD;
      recurrence; any technical, biological, or any other reasonable obstacle of treating patients&#xD;
      with fixed dentures; and finally patients in the matched control group financing fixed oral&#xD;
      prosthesis themselves.&#xD;
&#xD;
      Background data like sex, age, diagnosis, TNM-classification, hyposalivation, vertical jaw&#xD;
      mobility, dysphagia, number and sites of extracted teeth, and weight will be investigated.&#xD;
&#xD;
      Statistical analysis, quantitative and qualitative, will show differences in well-being and&#xD;
      mouth-related quality of life between the different groups studied.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2013</start_date>
  <completion_date type="Actual">September 17, 2021</completion_date>
  <primary_completion_date type="Actual">September 17, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Single group for the control vs. intervention group. Crossover model within the intervention group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oral Health Related Quality of Life (OHRQL), OHIP-14, BL/T1</measure>
    <time_frame>Baseline</time_frame>
    <description>Specific quality of life measured by the Oral Health Impact Profile (OHIP-14). OHRQL measurements are constructed to provide information about oral symptoms and related psychosocial and functional problems in dental public health perspectives as well as in clinical trials. Thus, when identifying and selecting a measure of OHRQL it is essential to use one with acceptable reliability and validity measuring the intended aims of the research. OHIP-14 is an instrument consisting of 14 items. Range 14 (better OHRQL) to 70 (worse OHRQL). It was designed to provide a comprehensive measure of the dysfunction, discomfort and disability attributed to oral conditions. Validated Swedish versions of the OHIP-14 are available.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oral Health Related Quality of Life (OHRQL), OHIP-14, T2</measure>
    <time_frame>6 months after completed radiotherapy</time_frame>
    <description>Specific quality of life measured by the Oral Health Impact Profile (OHIP-14). OHRQL measurements are constructed to provide information about oral symptoms and related psychosocial and functional problems in dental public health perspectives as well as in clinical trials. Thus, when identifying and selecting a measure of OHRQL it is essential to use one with acceptable reliability and validity measuring the intended aims of the research. OHIP-14 is an instrument consisting of 14 items. Range 14 (better OHRQL) to 70 (worse OHRQL). It was designed to provide a comprehensive measure of the dysfunction, discomfort and disability attributed to oral conditions. Validated Swedish versions of the OHIP-14 are available.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oral Health Related Quality of Life (OHRQL), OHIP-14, T3</measure>
    <time_frame>12 months after completed radiotherapy</time_frame>
    <description>Specific quality of life measured by the Oral Health Impact Profile (OHIP-14). OHRQL measurements are constructed to provide information about oral symptoms and related psychosocial and functional problems in dental public health perspectives as well as in clinical trials. Thus, when identifying and selecting a measure of OHRQL it is essential to use one with acceptable reliability and validity measuring the intended aims of the research. OHIP-14 is an instrument consisting of 14 items. Range 14 (better OHRQL) to 70 (worse OHRQL). It was designed to provide a comprehensive measure of the dysfunction, discomfort and disability attributed to oral conditions. Validated Swedish versions of the OHIP-14 are available.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oral Health Related Quality of Life (OHRQL), GOHAI, BL/T1</measure>
    <time_frame>Baseline</time_frame>
    <description>Specific quality of life measured by the General Oral Health Assessment Index (GOHAI) which is a 12-item instrument originally developed for use with older adult populations, although more recently it has been used with populations of younger adults. Range 12 (worse OHRQL) to 60 (better OHRQL). It measures oral functional problems and also assesses the psychosocial impacts associated with oral disease. A Swedish version has been validated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oral Health Related Quality of Life (OHRQL), GOHAI, T2</measure>
    <time_frame>6 months after completed radiotherapy</time_frame>
    <description>Specific quality of life measured by the General Oral Health Assessment Index (GOHAI) which is a 12-item instrument originally developed for use with older adult populations, although more recently it has been used with populations of younger adults. Range 12 (worse OHRQL) to 60 (better OHRQL). It measures oral functional problems and also assesses the psychosocial impacts associated with oral disease. A Swedish version has been validated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oral Health Related Quality of Life (OHRQL), GOHAI, T3</measure>
    <time_frame>12 months after completed radiotherapy</time_frame>
    <description>Specific quality of life measured by the General Oral Health Assessment Index (GOHAI) which is a 12-item instrument originally developed for use with older adult populations, although more recently it has been used with populations of younger adults. Range 12 (worse OHRQL) to 60 (better OHRQL). It measures oral functional problems and also assesses the psychosocial impacts associated with oral disease. A Swedish version has been validated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wellbeing, Quality of Life (QoL), SF-36v2, BL/T1</measure>
    <time_frame>Baseline</time_frame>
    <description>General quality of life measured by the SF-36 v2. SF-36v2 is a well established psychometric instrument with 36 items measuring eight domains of health-related quality of life: Physical function, physical role function, bodily pain, general health, vitality, social function, emotional role function, mental health. The two comprehensive indices - physical health and mental health - can be estimated for. Range 0 (worse QoL) to 100 (better QoL). The instrument is translated and validated into Swedish.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wellbeing, Quality of Life (QoL), SF-36v2, T2</measure>
    <time_frame>6 months after completed radiotherapy</time_frame>
    <description>General quality of life measured by the SF-36 v2. SF-36v2 is a well established psychometric instrument with 36 items measuring eight domains of health-related quality of life: Physical function, physical role function, bodily pain, general health, vitality, social function, emotional role function, mental health. The two comprehensive indices - physical health and mental health - can be estimated for. Range 0 (worse QoL) to 100 (better QoL). The instrument is translated and validated into Swedish.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wellbeing, Quality of Life (QoL), SF-36v2, T3</measure>
    <time_frame>12 months after completed radiotherapy</time_frame>
    <description>General quality of life measured by the SF-36 v2. SF-36v2 is a well established psychometric instrument with 36 items measuring eight domains of health-related quality of life: Physical function, physical role function, bodily pain, general health, vitality, social function, emotional role function, mental health. The two comprehensive indices - physical health and mental health - can be estimated for. Range 0 (worse QoL) to 100 (better QoL). The instrument is translated and validated into Swedish.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wellbeing, Health Related Quality of Life (HRQoL), EQ-5D, BL/T1</measure>
    <time_frame>Baseline</time_frame>
    <description>General quality of life measured by the EQ-5D which is an instrument containing five items measuring mobility, self-care, pain, role function, and anxiety/depression. There is also one item considering change of health condition and a VAS scale for general health. There is no total score, however there are different levels of HRQoL: Level 1. better HRQoL; Level 3. worse HRQoL. This instrument is translated and validated into Swedish.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wellbeing, Health Related Quality of Life (HRQoL), EQ-5D, T2</measure>
    <time_frame>6 months after completed radiotherapy</time_frame>
    <description>General quality of life measured by the EQ-5D which is an instrument containing five items measuring mobility, self-care, pain, role function, and anxiety/depression. There is also one item considering change of health condition and a VAS scale for general health. There is no total score, however there are different levels of HRQoL: Level 1. better HRQoL; Level 3. worse HRQoL. This instrument is translated and validated into Swedish.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wellbeing, Health Related Quality of Life (HRQoL), EQ-5D, T3</measure>
    <time_frame>12 months after completed radiotherapy</time_frame>
    <description>General quality of life measured by the EQ-5D which is an instrument containing five items measuring mobility, self-care, pain, role function, and anxiety/depression. There is also one item considering change of health condition and a VAS scale for general health. There is no total score, however there are different levels of HRQoL: Level 1. better HRQoL; Level 3. worse HRQoL. This instrument is translated and validated into Swedish.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Head and Neck Neoplasms</condition>
  <condition>Dental Prosthesis</condition>
  <condition>Dentures</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dentures (fixed oral prosthesis) compared with standard treatment (removable oral prosthesis).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fixed prosthodontics</intervention_name>
    <description>The intervention takes place six months after finishing radiotherapy.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with head and neck tumours considered to receive radiotherapy, with&#xD;
             or without combination of chemotherapy or surgery&#xD;
&#xD;
          -  Good oncological prognosis at baseline.&#xD;
&#xD;
          -  Patients diagnosed with dental infections and therapy planned for dental&#xD;
             extraction(s).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unwillingness to participate in the study.&#xD;
&#xD;
          -  Patients with communication problems.&#xD;
&#xD;
          -  Patients with comorbidity with poor prognosis.&#xD;
&#xD;
          -  Patients with poor oncological prognosis at baseline.&#xD;
&#xD;
          -  Patients with imminent risk of recurrence.&#xD;
&#xD;
          -  Patients with any technical, biological, or any other reasonable obstacle of treating&#xD;
             patients with fixed dentures&#xD;
&#xD;
          -  Patients in the matched control group financing fixed oral prosthesis themselves.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dan Malm, Assoc Prof</last_name>
    <role>Study Director</role>
    <affiliation>School of Health and Science, Jönköping Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Public Dental Health</name>
      <address>
        <city>Jönköping</city>
        <zip>58185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
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  <verification_date>March 2021</verification_date>
  <study_first_submitted>November 7, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>May 18, 2022</last_update_submitted>
  <last_update_submitted_qc>May 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Region Jönköping County</investigator_affiliation>
    <investigator_full_name>Carl-Otto Brahm, LDS, PhD</investigator_full_name>
    <investigator_title>LDS, PhD, specialist in oral medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 5, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/32/NCT03753932/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03753932
org study id: FORSS-385261
secondary id: FORSS-341741
secondary id: FUTURUM-265981
nct id: NCT03753932
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the multi centre study is to evaluate an intervention, which means that
      patients undergoing radiotherapy for head and neck cancer will receive fixed dentures in
      accordance with the Public Health Care fee system with regard to well-being and oral health
      related quality of life.

      Hypotheses: the intervention will improve oral health related quality of life, general
      wellbeing, and nutrition in patients treated by radiotherapy, with or without combination of
      chemotherapy or surgery against head and neck cancer.
The oncological care is multidisciplinary. In the investigation phase for radiotherapy, the
      Ear-Nose-Throat (ENT) physician refer the patient for a dental examination. Any dental
      infections are treated to reduce the risk of radiation-related infections that may occur
      after cancer treatment. This may mean that infected but symptom-free teeth, which the patient
      experiences as healthy need to be removed. This prophylactic dental treatment is charged
      according to the Public Health Care fee system.

      The study will take place in one major and in four middle sized counties in Sweden. The
      intervention will include 30 patients with head and neck cancer recruited from a Department
      of Maxillofacial and Oral Surgery (the City of Jönköping, Jönköping County Council), and from
      the Department of Orofacial Medicine (the City of Stockholm, Stockholm County Council).
      Another 30 patients with the same disease will be matched controls recruited from another
      Department of Maxillofacial and Oral Surgery (the City of Linköping, County Council of
      Östergötland) and from five Departments of Orofacial Medicine (the Cities of Kalmar,
      Oskarshamn, and Västervik, Kalmar County Council; the City of Växjö, Kronoberg County
      Council).

      The project consists of three sub-studies: A quantitative study; a qualitative study; and a
      health economics study. About 30 patients will be included in the intervention group, as well
      as about 30 matched control patients. Data collection will take place with questionnaires
      (SF-36, EQ-5D, OHIP-14, GOHAI, JFLS-8, OAS) and interviews.

      Patients recruited to the intervention group will be treated prosthodontically with removable
      and later with fixed dentures, thus acting as their own controls.

      If possible but not necessary, those controls may be prosthodontically rehabilitated with
      temporary removable dentures.

      The inclusion criteria are patients with head and neck tumours considered to receive
      radiotherapy, with or without combination of chemotherapy or surgery, good oncological
      prognosis at baseline. After referral from an ENT-specialist, those patients being diagnosed
      with dental infections and therapy planned for dental extraction(s) will be included.

      The following general exclusion criteria will be applied: any communication problems; any
      comorbidity with poor prognosis; poor oncological prognosis at baseline; imminent risk of
      recurrence; any technical, biological, or any other reasonable obstacle of treating patients
      with fixed dentures; and finally patients in the matched control group financing fixed oral
      prosthesis themselves.

      Background data like sex, age, diagnosis, TNM-classification, hyposalivation, vertical jaw
      mobility, dysphagia, number and sites of extracted teeth, and weight will be investigated.

      Statistical analysis, quantitative and qualitative, will show differences in well-being and
      mouth-related quality of life between the different groups studied.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single group for the control vs. intervention group. Crossover model within the intervention group.
primary purpose: Treatment
masking: None (Open Label)
measure: Oral Health Related Quality of Life (OHRQL), OHIP-14, BL/T1
time frame: Baseline
description: Specific quality of life measured by the Oral Health Impact Profile (OHIP-14). OHRQL measurements are constructed to provide information about oral symptoms and related psychosocial and functional problems in dental public health perspectives as well as in clinical trials. Thus, when identifying and selecting a measure of OHRQL it is essential to use one with acceptable reliability and validity measuring the intended aims of the research. OHIP-14 is an instrument consisting of 14 items. Range 14 (better OHRQL) to 70 (worse OHRQL). It was designed to provide a comprehensive measure of the dysfunction, discomfort and disability attributed to oral conditions. Validated Swedish versions of the OHIP-14 are available.
measure: Oral Health Related Quality of Life (OHRQL), OHIP-14, T2
time frame: 6 months after completed radiotherapy
description: Specific quality of life measured by the Oral Health Impact Profile (OHIP-14). OHRQL measurements are constructed to provide information about oral symptoms and related psychosocial and functional problems in dental public health perspectives as well as in clinical trials. Thus, when identifying and selecting a measure of OHRQL it is essential to use one with acceptable reliability and validity measuring the intended aims of the research. OHIP-14 is an instrument consisting of 14 items. Range 14 (better OHRQL) to 70 (worse OHRQL). It was designed to provide a comprehensive measure of the dysfunction, discomfort and disability attributed to oral conditions. Validated Swedish versions of the OHIP-14 are available.
measure: Oral Health Related Quality of Life (OHRQL), OHIP-14, T3
time frame: 12 months after completed radiotherapy
description: Specific quality of life measured by the Oral Health Impact Profile (OHIP-14). OHRQL measurements are constructed to provide information about oral symptoms and related psychosocial and functional problems in dental public health perspectives as well as in clinical trials. Thus, when identifying and selecting a measure of OHRQL it is essential to use one with acceptable reliability and validity measuring the intended aims of the research. OHIP-14 is an instrument consisting of 14 items. Range 14 (better OHRQL) to 70 (worse OHRQL). It was designed to provide a comprehensive measure of the dysfunction, discomfort and disability attributed to oral conditions. Validated Swedish versions of the OHIP-14 are available.
measure: Oral Health Related Quality of Life (OHRQL), GOHAI, BL/T1
time frame: Baseline
description: Specific quality of life measured by the General Oral Health Assessment Index (GOHAI) which is a 12-item instrument originally developed for use with older adult populations, although more recently it has been used with populations of younger adults. Range 12 (worse OHRQL) to 60 (better OHRQL). It measures oral functional problems and also assesses the psychosocial impacts associated with oral disease. A Swedish version has been validated.
measure: Oral Health Related Quality of Life (OHRQL), GOHAI, T2
time frame: 6 months after completed radiotherapy
description: Specific quality of life measured by the General Oral Health Assessment Index (GOHAI) which is a 12-item instrument originally developed for use with older adult populations, although more recently it has been used with populations of younger adults. Range 12 (worse OHRQL) to 60 (better OHRQL). It measures oral functional problems and also assesses the psychosocial impacts associated with oral disease. A Swedish version has been validated.
measure: Oral Health Related Quality of Life (OHRQL), GOHAI, T3
time frame: 12 months after completed radiotherapy
description: Specific quality of life measured by the General Oral Health Assessment Index (GOHAI) which is a 12-item instrument originally developed for use with older adult populations, although more recently it has been used with populations of younger adults. Range 12 (worse OHRQL) to 60 (better OHRQL). It measures oral functional problems and also assesses the psychosocial impacts associated with oral disease. A Swedish version has been validated.
measure: Wellbeing, Quality of Life (QoL), SF-36v2, BL/T1
time frame: Baseline
description: General quality of life measured by the SF-36 v2. SF-36v2 is a well established psychometric instrument with 36 items measuring eight domains of health-related quality of life: Physical function, physical role function, bodily pain, general health, vitality, social function, emotional role function, mental health. The two comprehensive indices - physical health and mental health - can be estimated for. Range 0 (worse QoL) to 100 (better QoL). The instrument is translated and validated into Swedish.
measure: Wellbeing, Quality of Life (QoL), SF-36v2, T2
time frame: 6 months after completed radiotherapy
description: General quality of life measured by the SF-36 v2. SF-36v2 is a well established psychometric instrument with 36 items measuring eight domains of health-related quality of life: Physical function, physical role function, bodily pain, general health, vitality, social function, emotional role function, mental health. The two comprehensive indices - physical health and mental health - can be estimated for. Range 0 (worse QoL) to 100 (better QoL). The instrument is translated and validated into Swedish.
measure: Wellbeing, Quality of Life (QoL), SF-36v2, T3
time frame: 12 months after completed radiotherapy
description: General quality of life measured by the SF-36 v2. SF-36v2 is a well established psychometric instrument with 36 items measuring eight domains of health-related quality of life: Physical function, physical role function, bodily pain, general health, vitality, social function, emotional role function, mental health. The two comprehensive indices - physical health and mental health - can be estimated for. Range 0 (worse QoL) to 100 (better QoL). The instrument is translated and validated into Swedish.
measure: Wellbeing, Health Related Quality of Life (HRQoL), EQ-5D, BL/T1
time frame: Baseline
description: General quality of life measured by the EQ-5D which is an instrument containing five items measuring mobility, self-care, pain, role function, and anxiety/depression. There is also one item considering change of health condition and a VAS scale for general health. There is no total score, however there are different levels of HRQoL: Level 1. better HRQoL; Level 3. worse HRQoL. This instrument is translated and validated into Swedish.
measure: Wellbeing, Health Related Quality of Life (HRQoL), EQ-5D, T2
time frame: 6 months after completed radiotherapy
description: General quality of life measured by the EQ-5D which is an instrument containing five items measuring mobility, self-care, pain, role function, and anxiety/depression. There is also one item considering change of health condition and a VAS scale for general health. There is no total score, however there are different levels of HRQoL: Level 1. better HRQoL; Level 3. worse HRQoL. This instrument is translated and validated into Swedish.
measure: Wellbeing, Health Related Quality of Life (HRQoL), EQ-5D, T3
time frame: 12 months after completed radiotherapy
description: General quality of life measured by the EQ-5D which is an instrument containing five items measuring mobility, self-care, pain, role function, and anxiety/depression. There is also one item considering change of health condition and a VAS scale for general health. There is no total score, however there are different levels of HRQoL: Level 1. better HRQoL; Level 3. worse HRQoL. This instrument is translated and validated into Swedish.
arm group label: Intervention
arm group type: Experimental
description: Dentures (fixed oral prosthesis) compared with standard treatment (removable oral prosthesis).
intervention type: Device
intervention name: Fixed prosthodontics
description: The intervention takes place six months after finishing radiotherapy.
arm group label: Intervention
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Dan Malm, Assoc Prof
role: Study Director
affiliation: School of Health and Science, Jönköping Sweden
facility: 
country: Sweden
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responsible party type: Principal Investigator
investigator affiliation: Region Jönköping County
investigator full name: Carl-Otto Brahm, LDS, PhD
investigator title: LDS, PhD, specialist in oral medicine
mesh term: Head and Neck Neoplasms
sharing ipd: No
provided document: 