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Evolution of Masticatory Function, Orofacial Functions and Quality of Life of Patients Treated for Cancers of the Upper Aerodigestive Tract, Rehabilitated by Maxillofacial Prostheses.

Evolution of Masticatory Function, Orofacial Functions and Quality of Life of Patients Treated for Cancers of the Upper Aerodigestive Tract, Rehabilitated by Maxillofacial Prostheses.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07471451
Acronym
RMF-CROC
Enrollment
50
Registered
2026-03-13
Start date
2026-05-20
Completion date
2030-05-01
Last updated
2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

mastication, chewing, cancer of the upper aerodigestive tract, prosthetic rehabilitation, oral-facial functions, quality of life, oral health, oral quality of life

Brief summary

This is a follow-up study of masticatory function, orofacial functions, and quality of life in patients with a history of upper aerodigestive tract cancer who have undergone rehabilitation with maxillofacial prostheses. The main objective of this study is to evaluate changes in masticatory function during a prosthetic rehabilitation program in patients with a history of upper aerodigestive tract cancer.

Detailed description

Patients are recruited and monitored within the maxillofacial prosthesis consultation of the Odontology Department at the Estaing University Hospital in Clermont - Ferrand. An objective assessment (clinical examination and functional tests) by a dentist, combined with a subjective assessment (questionnaires) by the patient, is carried out before and after maxillofacial prosthetic rehabilitation. The study includes three assessment periods : T0, before maxillofacial prosthetic rehabilitation ; T1, three months after prosthetic rehabilitation ; and T2, one year after prosthetic rehabilitation. Each evaluation stage includes an interview, a clinical examination, and functional tests. During the interview, patients are asked to complete questionnaires to assess their oral quality of life, dysphagia, orofacial functions, anxiety about treatment, and integration of their prostheses (from T1 onwards). The clinical examination assesses the patient's oral health (dental pattern, mandibular kinematics, occlusion) and tongue function (tongue mobility). Finally, the functional tests evaluate salivary function , chewing, and tongue strength. To study salivation, the patient is asked to spit their saliva into a container with or without prior stimulation, in order to measure salivary flow. For the chewing study, the patient must chew a test food (carrot) or chewing gum, which will be spat out for analysis.

Interventions

Prosthetic oral rehabilitation to restore oral function in patients with a history of upper aerodigestive tract cancer.

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patient who has given their consent * Patient with a history of upper aerodigestive tract cancer * Cooperative patient * Patient affiliated with a Social Security scheme * Patient capable of understanding and participating in the study * Patient not allergic to the foods being tested

Exclusion criteria

* Minors * Patients treated in the maxillofacial prosthetics clinic of the Odontology Department at Estaing University Hospital in Clermont Ferrand who do not require prosthetic rehabilitation * Patients who are unwilling to participate in the study, particularly in attending the various follow-up sessions * Patients who do not have a good command of written and spoken French * Patients under guardianship, curatorship, or judicial protection * Pregnant or breastfeeding patients * Patients receiving enteral or parenteral nutrition * Patients who have been diagnosed with a recurrence of their cancer and whose prognosis is life-threatening. * Patients with cognitive impairment

Design outcomes

Primary

MeasureTime frameDescription
Particle size distribution of food bolus collected at the swallowing thresholdBaseline (T0) ; T1 (T0 + 3 months) ; T2 (T0 + 1 year)Particle size distribution of food bolus collected at the swallowing threshold for raw carrot samples (CAR), objectified by the D50 value : median value of the particle size of each food bolus

Countries

France

Contacts

CONTACTLise LACLAUTRE
promo_interne_drci@chu-clermontferrand.fr+334.73.754.963
PRINCIPAL_INVESTIGATORCindy BATISSE LANCE

CHU de Clermont-Fd

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026