Impact of Fixed Dentures in Head and Neck Cancer (IMFDHAC)
NCT ID: NCT03753932
Last Updated: 2022-05-19
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
64 participants
Study Classification
INTERVENTIONAL
Study Start Date
2013-03-01
Study Completion Date
2021-09-17
Brief Summary
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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.
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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Detailed Description
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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.
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
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Head and Neck Neoplasms
Dental Prosthesis
Dentures
Quality of Life
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Single group for the control vs. intervention group. Crossover model within the intervention group.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Intervention
Dentures (fixed oral prosthesis) compared with standard treatment (removable oral prosthesis).
Group Type
EXPERIMENTAL
Fixed prosthodontics
Intervention Type
DEVICE
The intervention takes place six months after finishing radiotherapy.
Interventions
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Fixed prosthodontics
The intervention takes place six months after finishing radiotherapy.
Intervention Type
DEVICE
Eligibility Criteria
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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).
* 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.
* 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.
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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School of Health Sciences, Jönköping University, Jönköping Sweden
UNKNOWN
Sponsor Role
collaborator
Malmö University
OTHER
Sponsor Role
collaborator
Region Jönköping County
OTHER_GOV
Sponsor Role
lead
Responsible Party
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Carl-Otto Brahm, LDS, PhD
LDS, PhD, specialist in oral medicine
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Dan Malm, Assoc Prof
Role: STUDY_DIRECTOR
School of Health and Science, Jönköping Sweden
Locations
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Public Dental Health
Jönköping, , Sweden
Site Status
Countries
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Sweden
References
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Vissink 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.
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Jham 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.
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Korfage 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.
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RESULT
Jager-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.
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Dwivedi 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.
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John 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.
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RESULT
Lekholm 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.
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Jemt 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.
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Shaw 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.
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Sullivan M, Karlsson J, Ware JE Jr. The Swedish SF-36 Health Survey--I. Evaluation of data quality, scaling assumptions, reliability and construct validity across general populations in Sweden. Soc Sci Med. 1995 Nov;41(10):1349-58. doi: 10.1016/0277-9536(95)00125-q.
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Persson LO, Karlsson J, Bengtsson C, Steen B, Sullivan M. The Swedish SF-36 Health Survey II. Evaluation of clinical validity: results from population studies of elderly and women in Gothenborg. J Clin Epidemiol. 1998 Nov;51(11):1095-103. doi: 10.1016/s0895-4356(98)00101-2.
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Sullivan M, Karlsson J. The Swedish SF-36 Health Survey III. Evaluation of criterion-based validity: results from normative population. J Clin Epidemiol. 1998 Nov;51(11):1105-13. doi: 10.1016/s0895-4356(98)00102-4.
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Larsson B, Johannesson A, Andersson IH, Atroshi I. The Locomotor Capabilities Index; validity and reliability of the Swedish version in adults with lower limb amputation. Health Qual Life Outcomes. 2009 May 23;7:44. doi: 10.1186/1477-7525-7-44.
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Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.
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Hagglin C, Berggren U, Hakeberg M, Edvardsson A, Eriksson M. Evaluation of a Swedish version of the OHIP-14 among patients in general and specialist dental care. Swed Dent J. 2007;31(2):91-101.
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Larsson P, List T, Lundstrom I, Marcusson A, Ohrbach R. Reliability and validity of a Swedish version of the Oral Health Impact Profile (OHIP-S). Acta Odontol Scand. 2004 Jun;62(3):147-52. doi: 10.1080/00016350410001496.
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Atchison KA, Dolan TA. Development of the Geriatric Oral Health Assessment Index. J Dent Educ. 1990 Nov;54(11):680-7.
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Hagglin C, Berggren U, Lundgren J. A Swedish version of the GOHAI index. Psychometric properties and validation. Swed Dent J. 2005;29(3):113-24.
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RESULT
Larsson P. Methodological studies of orofacial aesthetics, orofacial function and oral health-related quality of life. Swed Dent J Suppl. 2010;(204):11-98.
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RESULT
Ohrbach R, Larsson P, List T. The jaw functional limitation scale: development, reliability, and validity of 8-item and 20-item versions. J Orofac Pain. 2008 Summer;22(3):219-30.
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RESULT
Larsson P, John MT, Nilner K, List T. Reliability and validity of the Orofacial Esthetic Scale in prosthodontic patients. Int J Prosthodont. 2010 May-Jun;23(3):257-62.
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RESULT
Larsson P, John MT, Nilner K, Bondemark L, List T. Development of an Orofacial Esthetic Scale in prosthodontic patients. Int J Prosthodont. 2010 May-Jun;23(3):249-56.
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RESULT
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Reference Type
RESULT
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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FORSS-341741
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
FUTURUM-265981
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
FORSS-385261
Identifier Type: -
Identifier Source: org_study_id
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