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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A02714-45 | Other Identifier | ANSM |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prosthetic rehabilitation program | Experimental | Patients with a history of upper aerodigestive tract cancer undergoing prosthetic oral rehabilitation aimed at restoring masticatory function. The evolution of masticatory function is assessed throughout the rehabilitation program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prosthetic oral rehabilitation | Procedure | Prosthetic oral rehabilitation to restore oral function in patients with a history of upper aerodigestive tract cancer. |
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| Measure | Description | Time Frame |
|---|---|---|
| Particle size distribution of food bolus collected at the swallowing threshold | 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 | Baseline (T0) ; T1 (T0 + 3 months) ; T2 (T0 + 1 year) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise LACLAUTRE | Contact | +334.73.754.963 | promo_interne_drci@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Cindy BATISSE LANCE | CHU de Clermont-Fd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont-Fd | Recruiting | Clermont-Ferrand | 63000 | France |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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