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临床试验/NCT07471451
NCT07471451招募中不适用

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

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年5月20日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Particle size distribution of food bolus collected at the swallowing threshold

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Prosthetic oral rehabilitation (Procedure)

结局指标

主要结局

Particle size distribution of food bolus collected at the swallowing threshold

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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