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Trial record 1 of 1 for:    NCT03753932
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Impact of Fixed Dentures in Head and Neck Cancer (IMFDHAC) (IMFDHAC)

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ClinicalTrials.gov Identifier: NCT03753932
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : November 27, 2018
Sponsor:
Collaborator:
School of Health Sciences, Jönköping University, Jönköping Sweden
Information provided by (Responsible Party):
Carl-Otto Brahm, LDS, PhD, Region Jönköping County

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Dental Prosthesis Dentures Quality of Life Device: Fixed prosthodontics Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 1, 2013
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Dentures (fixed oral prosthesis) compared with standard treatment (removable oral prosthesis).
Device: Fixed prosthodontics
The intervention takes place six months after finishing radiotherapy.




Primary Outcome Measures :
  1. Oral Health Related Quality of Life (OHRQL), OHIP-14, BL/T1 [ Time Frame: Baseline ]
    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.

  2. Oral Health Related Quality of Life (OHRQL), OHIP-14, T2 [ Time Frame: 6 months after completed radiotherapy ]
    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.

  3. Oral Health Related Quality of Life (OHRQL), OHIP-14, T3 [ Time Frame: 12 months after completed radiotherapy ]
    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.

  4. Oral Health Related Quality of Life (OHRQL), GOHAI, BL/T1 [ Time Frame: Baseline ]
    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.

  5. Oral Health Related Quality of Life (OHRQL), GOHAI, T2 [ Time Frame: 6 months after completed radiotherapy ]
    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.

  6. Oral Health Related Quality of Life (OHRQL), GOHAI, T3 [ Time Frame: 12 months after completed radiotherapy ]
    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.


Secondary Outcome Measures :
  1. Wellbeing, Quality of Life (QoL), SF-36v2, BL/T1 [ Time Frame: Baseline ]
    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.

  2. Wellbeing, Quality of Life (QoL), SF-36v2, T2 [ Time Frame: 6 months after completed radiotherapy ]
    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.

  3. Wellbeing, Quality of Life (QoL), SF-36v2, T3 [ Time Frame: 12 months after completed radiotherapy ]
    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.

  4. Wellbeing, Health Related Quality of Life (HRQoL), EQ-5D, BL/T1 [ Time Frame: Baseline ]
    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.

  5. Wellbeing, Health Related Quality of Life (HRQoL), EQ-5D, T2 [ Time Frame: 6 months after completed radiotherapy ]
    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.

  6. Wellbeing, Health Related Quality of Life (HRQoL), EQ-5D, T3 [ Time Frame: 12 months after completed radiotherapy ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed with head and neck tumours considered to receive radiotherapy, with or without combination of chemotherapy or surgery
  • Good oncological prognosis at baseline.
  • Patients diagnosed with dental infections and therapy planned for dental extraction(s).

Exclusion Criteria:

  • Unwillingness to participate in the study.
  • Patients with communication problems.
  • Patients with comorbidity with poor prognosis.
  • Patients with poor oncological prognosis at baseline.
  • Patients with imminent risk of recurrence.
  • Patients with any technical, biological, or any other reasonable obstacle of treating patients with fixed dentures
  • Patients in the matched control group financing fixed oral prosthesis themselves.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03753932


Contacts
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Contact: Carl-Otto Brahm, LDS, PhD +46 10-2426051 carl-otto.brahm@rjl.se

Locations
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Sweden
Public Dental Health Recruiting
Jönköping, Sweden, 58185
Contact: Carl-Otto Brahm, LDS, PhD    +46 10-2426051    carl-otto.brahm@rjl.se   
Principal Investigator: Martin Ljungberg, LDS         
Principal Investigator: Ahmed Zemar, LDS         
Principal Investigator: Marie Svensson, LDS         
Principal Investigator: Britt Grumert, LDS         
Principal Investigator: Lis Cöster, LDS         
Sponsors and Collaborators
Region Jönköping County
School of Health Sciences, Jönköping University, Jönköping Sweden
Investigators
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Study Director: Dan Malm, Assoc Prof School of Health and Science, Jönköping Sweden
  Study Documents (Full-Text)

Documents provided by Carl-Otto Brahm, LDS, PhD, Region Jönköping County:
Study Protocol  [PDF] September 5, 2017

Publications of Results:

Other Publications:
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Responsible Party: Carl-Otto Brahm, LDS, PhD, LDS, PhD, specialist in oral medicine, Region Jönköping County
ClinicalTrials.gov Identifier: NCT03753932    
Other Study ID Numbers: FORSS-385261
FORSS-341741 ( Other Grant/Funding Number: FORSS )
FUTURUM-265981 ( Other Grant/Funding Number: Futurum )
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms