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

NCT03753932 | Completed

• 3 other identifiers: FORSS-385261FORSS-341741FUTURUM-265981
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Neoplasms; Dental Prosthesis; Dentures; Quality of Life

Outcome Measures

Primary Outcomes (6)

• Oral Health Related Quality of Life (OHRQL), OHIP-14, BL/T1

  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.

  Baseline

• Oral Health Related Quality of Life (OHRQL), OHIP-14, T2

  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.

  6 months after completed radiotherapy

• Oral Health Related Quality of Life (OHRQL), OHIP-14, T3

  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.

  12 months after completed radiotherapy

• Oral Health Related Quality of Life (OHRQL), GOHAI, BL/T1

  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.

  Baseline

• Oral Health Related Quality of Life (OHRQL), GOHAI, T2

  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 months after completed radiotherapy

• Oral Health Related Quality of Life (OHRQL), GOHAI, T3

  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.

  12 months after completed radiotherapy

Secondary Outcomes (6)

• Wellbeing, Quality of Life (QoL), SF-36v2, BL/T1

  Baseline

• Wellbeing, Quality of Life (QoL), SF-36v2, T2

  6 months after completed radiotherapy

• Wellbeing, Quality of Life (QoL), SF-36v2, T3

  12 months after completed radiotherapy

• Wellbeing, Health Related Quality of Life (HRQoL), EQ-5D, BL/T1

  Baseline

• Wellbeing, Health Related Quality of Life (HRQoL), EQ-5D, T2

  6 months after completed radiotherapy

Study Arms (1)

Intervention

EXPERIMENTAL

Dentures (fixed oral prosthesis) compared with standard treatment (removable oral prosthesis).

Device: Fixed prosthodontics

Interventions

Fixed prosthodontics DEVICE

The intervention takes place six months after finishing radiotherapy.

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Jönköping County: lead
• School of Health Sciences, Jönköping University, Jönköping Sweden: collaborator
• Malmö University: collaborator

Study Sites (1)

Public Dental Health

Jönköping, 58185, Sweden

Location

Related Publications (30)

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MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Dan Malm, Assoc Prof

  School of Health and Science, Jönköping Sweden

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: LDS, PhD, specialist in oral medicine

Model Details: Single group for the control vs. intervention group. Crossover model within the intervention group.

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 27, 2018
• Study Start: March 1, 2013
• Primary Completion: September 17, 2021
• Study Completion: September 17, 2021
• Last Updated: May 19, 2022

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)