Clinical trial · Interventional
Impact of Fixed Dentures in Head and Neck Cancer (IMFDHAC)
Patients With Head and Neck Cancer Treated by Radiotherapy: The Impact of Fixed Dentures on Wellbeing and Oral Health Related Quality of Life
NCT03753932CI-TRIAL-00058591IMFDHACcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dental Prosthesis | — | UNRESOLVED | — |
| Dentures | — | UNRESOLVED | — |
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fixed prosthodontics | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Dentures (fixed oral prosthesis) compared with standard treatment (removable oral prosthesis).
- interventionNames
- Device: Fixed prosthodontics
Primary outcomes (6)
- measure
- Oral Health Related Quality of Life (OHRQL), OHIP-14, BL/T1
- timeFrame
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (30)
- BACKGROUNDKorfage 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. PMID 20701621
- BACKGROUNDHsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687. PMID 16204405
- RESULTParkin 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. PMID 11668491
- RESULTVissink 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. PMID 12799323
- RESULTKielbassa 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. PMID 16574548
- RESULTJham 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. PMID 17221065
- RESULTStore 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. PMID 10505444
- RESULTKorfage 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.