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

Overview

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

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

Primary outcome measures

• Particle size distribution of food bolus collected at the swallowing threshold [Time frame: Baseline (T0) ; T1 (T0 + 3 months) ; T2 (T0 + 1 year)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

France · 1 center

• CHU de Clermont-Fd — Clermont-Ferrand

Identifiers

NCT: NCT07471451 · RBHP 2025 BATISSE LANCE · 2025-A02714-45

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗