Head and Neck NeoplasmsIMFDHACNCT03753932
Impact of Fixed Dentures in Head and Neck Cancer (IMFDHAC)
A study testing Fixed prosthodontics in people with Head and Neck Neoplasms and Dental Prosthesis, run by Region Jönköping County at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Head and Neck Neoplasms, Dental Prosthesis, Dentures
- What is being tested?
- Fixed prosthodontics
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2013to 17 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Head and Neck Neoplasms, Dental Prosthesis, Dentures, Quality of Life
- Being tested
- Fixed prosthodontics
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed prosthodonticsDevice
The intervention takes place six months after finishing radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Dentures (fixed oral prosthesis) compared with standard treatment (removable oral prosthesis). Receives: Device: Fixed prosthodontics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months after completed radiotherapy
Secondary outcomes (6)
Wellbeing, Quality of Life (QoL), SF-36v2, BL/T1
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.
Measured: Baseline
Wellbeing, Quality of Life (QoL), SF-36v2, T2
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.
Measured: 6 months after completed radiotherapy
Wellbeing, Quality of Life (QoL), SF-36v2, T3
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.
Measured: 12 months after completed radiotherapy
Wellbeing, Health Related Quality of Life (HRQoL), EQ-5D, BL/T1
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.
Measured: Baseline
Wellbeing, Health Related Quality of Life (HRQoL), EQ-5D, T2
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.
Measured: 6 months after completed radiotherapy
Wellbeing, Health Related Quality of Life (HRQoL), EQ-5D, T3
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.
Measured: 12 months after completed radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start1 Mar 2013
- Primary completion17 Sep 2021
- Study completion17 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group for the control vs. intervention group. Crossover model within the intervention group.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Jönköping County
- Sponsor type
- Other government
- Collaborators
- School of Health Sciences, Jönköping University, Jönköping Sweden, Malmö University
- Responsible party
- Principal investigator, Carl-Otto Brahm, LDS, PhD, Region Jönköping County
- Investigators
- Dan Malm, Assoc Prof, Study director, School of Health and Science, Jönköping Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753932
- Sponsor's protocol ID
- FORSS-385261
- Other IDs
- FORSS-341741, FUTURUM-265981
- Acronym
- IMFDHAC
- Status last verified
- Mar 2021
- First submitted
- 7 Nov 2018
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Korfage A, Schoen PJ, Raghoebar GM, Roodenburg JL, Vissink A, Reintsema H. Benefits of dental implants installed during ablative tumour surgery in oral cancer patients: a prospective 5-year clinical trial. Clin Oral Implants Res. 2010 Sep;21(9):971-9. doi: 10.1111/j.1600-0501.2010.01930.x.
PubMed 20701621Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.
PubMed 16204405Parkin DM, Bray F, Ferlay J, Pisani P. Estimating the world cancer burden: Globocan 2000. Int J Cancer. 2001 Oct 15;94(2):153-6. doi: 10.1002/ijc.1440. No abstract available.
PubMed 11668491Vissink A, Jansma J, Spijkervet FK, Burlage FR, Coppes RP. Oral sequelae of head and neck radiotherapy. Crit Rev Oral Biol Med. 2003;14(3):199-212. doi: 10.1177/154411130301400305.
PubMed 12799323Kielbassa AM, Hinkelbein W, Hellwig E, Meyer-Luckel H. Radiation-related damage to dentition. Lancet Oncol. 2006 Apr;7(4):326-35. doi: 10.1016/S1470-2045(06)70658-1.
PubMed 16574548Jham BC, da Silva Freire AR. Oral complications of radiotherapy in the head and neck. Braz J Otorhinolaryngol. 2006 Sep-Oct;72(5):704-8. doi: 10.1016/s1808-8694(15)31029-6.
PubMed 17221065Store G, Granstrom G. Osteoradionecrosis of the mandible: a microradiographic study of cortical bone. Scand J Plast Reconstr Surg Hand Surg. 1999 Sep;33(3):307-14. doi: 10.1080/02844319950159280.
PubMed 10505444Korfage A, Schoen PJ, Raghoebar GM, Bouma J, Burlage FR, Roodenburg JL, Vissink A, Reintsema H. Five-year follow-up of oral functioning and quality of life in patients with oral cancer with implant-retained mandibular overdentures. Head Neck. 2011 Jun;33(6):831-9. doi: 10.1002/hed.21544. Epub 2010 Dec 9.
PubMed 21560179Jager-Wittenaar H, Dijkstra PU, Vissink A, van der Laan BF, van Oort RP, Roodenburg JL. Malnutrition and quality of life in patients treated for oral or oropharyngeal cancer. Head Neck. 2011 Apr;33(4):490-6. doi: 10.1002/hed.21473. Epub 2010 Sep 7.
PubMed 20824806Dwivedi RC, Kazi RA, Agrawal N, Nutting CM, Clarke PM, Kerawala CJ, Rhys-Evans PH, Harrington KJ. Evaluation of speech outcomes following treatment of oral and oropharyngeal cancers. Cancer Treat Rev. 2009 Aug;35(5):417-24. doi: 10.1016/j.ctrv.2009.04.013. Epub 2009 May 29.
PubMed 19481871John MT, Slade GD, Szentpetery A, Setz JM. Oral health-related quality of life in patients treated with fixed, removable, and complete dentures 1 month and 6 to 12 months after treatment. Int J Prosthodont. 2004 Sep-Oct;17(5):503-11.
PubMed 15543905Lekholm U, Grondahl K, Jemt T. Outcome of oral implant treatment in partially edentulous jaws followed 20 years in clinical function. Clin Implant Dent Relat Res. 2006;8(4):178-86. doi: 10.1111/j.1708-8208.2006.00019.x.
PubMed 17100743Jemt T, Johansson J. Implant treatment in the edentulous maxillae: a 15-year follow-up study on 76 consecutive patients provided with fixed prostheses. Clin Implant Dent Relat Res. 2006;8(2):61-9. doi: 10.1111/j.1708-8208.2006.00003.x.
PubMed 16774591Andersson G, Andreasson L, Bjelkengren G. Oral implant rehabilitation in irradiated patients without adjunctive hyperbaric oxygen. Int J Oral Maxillofac Implants. 1998 Sep-Oct;13(5):647-54.
PubMed 9796148Shaw RJ, Sutton AF, Cawood JI, Howell RA, Lowe D, Brown JS, Rogers SN, Vaughan ED. Oral rehabilitation after treatment for head and neck malignancy. Head Neck. 2005 Jun;27(6):459-70. doi: 10.1002/hed.20176.
PubMed 15880417
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03753932
- Acronym / sponsor ID
- IMFDHAC / FORSS-385261
- Conditions
- Head and Neck Neoplasms, Dental Prosthesis, Dentures, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Region Jönköping CountyOther government
- Collaborators
- School of Health Sciences, Jönköping University, Jönköping Sweden, Malmö University
- Study start
- 1 Mar 2013 (actual)
- Primary completion
- 17 Sep 2021 (actual)
- Study completion
- 17 Sep 2021 (actual)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group for the control vs. intervention group. Crossover model within the intervention group.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Fixed prosthodonticsDentures (fixed oral prosthesis) compared with standard treatment (removable oral prosthesis). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fixed prosthodonticsThe intervention takes place six months after finishing radiotherapy. | Device | Intervention |
Primary outcome
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.
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.
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.
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.
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.
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.
6 secondary outcomes
Wellbeing, Quality of Life (QoL), SF-36v2, BL/T1
Time frame: Baseline
Wellbeing, Quality of Life (QoL), SF-36v2, T2
Time frame: 6 months after completed radiotherapy
Wellbeing, Quality of Life (QoL), SF-36v2, T3
Time frame: 12 months after completed radiotherapy
Wellbeing, Health Related Quality of Life (HRQoL), EQ-5D, BL/T1
Time frame: Baseline
Wellbeing, Health Related Quality of Life (HRQoL), EQ-5D, T2
Time frame: 6 months after completed radiotherapy
Wellbeing, Health Related Quality of Life (HRQoL), EQ-5D, T3
Time frame: 12 months after completed radiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Background: PubMed 20701621Korfage A, Schoen PJ, Raghoebar GM, Roodenburg JL, Vissink A, Reintsema H. Benefits of dental implants installed during ablative tumour surgery in oral cancer patients: a prospective 5-year clinical trial. Clin Oral Implants Res. 2010 Sep;21(9):971-9. doi: 10.1111/j.1600-0501.2010.01930.x.
- Background: PubMed 16204405Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.
- Results publication: PubMed 11668491Parkin DM, Bray F, Ferlay J, Pisani P. Estimating the world cancer burden: Globocan 2000. Int J Cancer. 2001 Oct 15;94(2):153-6. doi: 10.1002/ijc.1440. No abstract available.
- Results publication: PubMed 12799323Vissink A, Jansma J, Spijkervet FK, Burlage FR, Coppes RP. Oral sequelae of head and neck radiotherapy. Crit Rev Oral Biol Med. 2003;14(3):199-212. doi: 10.1177/154411130301400305.
- Results publication: PubMed 16574548Kielbassa AM, Hinkelbein W, Hellwig E, Meyer-Luckel H. Radiation-related damage to dentition. Lancet Oncol. 2006 Apr;7(4):326-35. doi: 10.1016/S1470-2045(06)70658-1.
- Results publication: PubMed 17221065Jham BC, da Silva Freire AR. Oral complications of radiotherapy in the head and neck. Braz J Otorhinolaryngol. 2006 Sep-Oct;72(5):704-8. doi: 10.1016/s1808-8694(15)31029-6.
- Results publication: PubMed 10505444Store G, Granstrom G. Osteoradionecrosis of the mandible: a microradiographic study of cortical bone. Scand J Plast Reconstr Surg Hand Surg. 1999 Sep;33(3):307-14. doi: 10.1080/02844319950159280.
- Results publication: PubMed 21560179Korfage A, Schoen PJ, Raghoebar GM, Bouma J, Burlage FR, Roodenburg JL, Vissink A, Reintsema H. Five-year follow-up of oral functioning and quality of life in patients with oral cancer with implant-retained mandibular overdentures. Head Neck. 2011 Jun;33(6):831-9. doi: 10.1002/hed.21544. Epub 2010 Dec 9.
- Results publication: PubMed 20824806Jager-Wittenaar H, Dijkstra PU, Vissink A, van der Laan BF, van Oort RP, Roodenburg JL. Malnutrition and quality of life in patients treated for oral or oropharyngeal cancer. Head Neck. 2011 Apr;33(4):490-6. doi: 10.1002/hed.21473. Epub 2010 Sep 7.
- Results publication: PubMed 19481871Dwivedi RC, Kazi RA, Agrawal N, Nutting CM, Clarke PM, Kerawala CJ, Rhys-Evans PH, Harrington KJ. Evaluation of speech outcomes following treatment of oral and oropharyngeal cancers. Cancer Treat Rev. 2009 Aug;35(5):417-24. doi: 10.1016/j.ctrv.2009.04.013. Epub 2009 May 29.
- Results publication: PubMed 15543905John MT, Slade GD, Szentpetery A, Setz JM. Oral health-related quality of life in patients treated with fixed, removable, and complete dentures 1 month and 6 to 12 months after treatment. Int J Prosthodont. 2004 Sep-Oct;17(5):503-11.
- Results publication: PubMed 17100743Lekholm U, Grondahl K, Jemt T. Outcome of oral implant treatment in partially edentulous jaws followed 20 years in clinical function. Clin Implant Dent Relat Res. 2006;8(4):178-86. doi: 10.1111/j.1708-8208.2006.00019.x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Malm, Assoc Prof study director
School of Health and Science, Jönköping Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fixed prosthodontics in people with Head and Neck Neoplasms and Dental Prosthesis, run by Region Jönköping County at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Health Related Quality of Life (OHRQL), OHIP-14, BL/T1 (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03753932, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.