CHU de Clermont-Fd
Clermont-Ferrand, 63000, France
Location status: Recruiting
NCT Number: NCT07471451
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Clermont-Ferrand, 63000, France
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Prosthetic oral rehabilitation to restore oral function in patients with a history of upper aerodigestive tract cancer.
Time frame: Baseline (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
Contact information is provided by the study sponsor or research team.
University Hospital, Clermont-Ferrand
Other
Acronym: RMF-CROC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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