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Completed

NCT Number: NCT03753932

Impact of Fixed Dentures in Head and Neck Cancer (IMFDHAC)

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.

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Key information

Conditions

Head and Neck Neoplasms Dental Prosthesis Dentures Neoplasms Neoplasms by Site Quality of Life

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Public Dental Health

Jönköping, 58185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fixed prosthodontics

Device

The intervention takes place six months after finishing radiotherapy.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Region Jönköping County

Other Gov

Collaborators

  • Malmö University
  • School of Health Sciences, Jönköping University, Jönköping Sweden

Registry information

Official study title

Patients With Head and Neck Cancer Treated by Radiotherapy: The Impact of Fixed Dentures on Wellbeing and Oral Health Related Quality of Life

Acronym: IMFDHAC

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
Nov 27, 2018
Registry last updated
May 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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