TOngue/Palate Interactions Study

Официальное название

Experimental Study of Tongue/Palate Interactions Using Upper coMplete dEnture

Обзор

The project aims to assess the effect of a complete denture of new denture wearers on speech production using sensors placed inside a duplicate of the prosthesis according to the technique described in the PRESLA system. Secondly, it aims to assess the effect of a complete denture on swallowing for these new denture wearers. Thirdly it aims to describe a precise mapping of the mechanical pressures exerted by the tongue on the palate of complete denture user, been used in wearing denture, during speaking and swallowing. The experiments will take place in the department of treatments and dental consultations of the Hospices Civils de Lyon (Faculty of Odontology, Lyon, France).

Подробное описание

The evaluation of speech production is based on the characteristics of the pressure signal (time and frequency) and the acoustic signal after synchronization during time using duplicate with up to 8 sensors.

To reach the first objective, the investigators will focus on the patients who wear new complete denture during the first session of recording. They will first analyze the characteristics of the acoustic and pressure signals of the production of consonants. They shall select from 8 sensors, 3 sensors for the inferential analysis: a previous sensor in the alveolar zone, a median sensor in the palatal zone and a posterior sensor in the palatal area (on the border of the beginning of the soft palate). These 3 sensors will be selected on the basis of the amplitude of the variations of pressure during the task. This sensor's triplet will be specific to every patient. The investigators shall thus have after 3 sensors called: previous, median, posterior. They shall do, for every sensor's measurements and for the acoustic measures, an inferential statistical analysis based on one model shelf spaces generalized in mixed effects, in which the variable to be explained will be one of moderate variables, the fixed effects will be the session (just after wearing the prosthesis for the first time, 3 weeks later, 3 months later), the consonant, the index of the sensor (1 - 3, from the front to the back) and the index of the repetition (from 1 to 15), and where the random effect will be the patient.

Вмешательства

• Устройство Tongue pressure recordings with the PRESLA prothesis for the Arm1 (patients wearing the complete denture for the first time)
  Tongue pressure recordings during speech production, wet and dry swallowing tasks planned in 3 sessions, when the complete denture is worn for the first time, after 3 weeks, then after 3 months in order to characterise the adaptation to this new prosthesis.
• Устройство Tongue pressure recordings with the PRESLA prothesis for the Arm2 (patients used to wear the complete denture)
  These measures provide to establish a spatial and temporal mapping of contacts applied by the tongue and lips to the prosthesis during speech production in patients used to their prosthesis. They also provide to establish a spatial and temporal mapping of contacts applied by the tongue and lips to the prosthesis during swallowing) in these patients. The measurement is made at once when the new denture which replaces the old one is placed in the mouth.

Первичные конечные точки

• Change from Baseline Pressure signal (time and amplitude) at week 3 and month 3, during speech production for new denture wearers using duplicate with up to 8 sensors [Срок оценки: Day 0 (Baseline), Week 3 and Month 3]
• Change from Baseline Pressure signal Acoustic signal (time and frequence) at week 3 and month 3, during speech production for new denture wearers using duplicate with up to 8 sensors [Срок оценки: Day 0 (Baseline), Week 3 and Month 3]

Критерии участия

Критерии включения

• Bimaxillary edentulous patients of both genders, over 18 years of age, requiring prosthesis (Cohort 1).
• Bimaxillary edentulous patients of both genders, over 18 years of age, with prosthesis made since at least one year (Cohort 2).
• Patients Affiliated with the French Social Security Insurance

Критерии исключения

• Patients with speech or neurological disorders, or uncorrected or psychiatric sensory disorders
• Patients without French as native language
• Pregnant women
• Patients deprived of liberty or provided with legal protection
• Patients unable to support study constraints as determined by investigator
• Patients who have expressed their refusal to participate with the investigator
• Allergy to methacrylic resin

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• Service de Consultations et de Traitements Dentaires des Hospices Civils de Lyon — Lyon

Идентификаторы

NCT: NCT03966131 · 69HCL18_0103

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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