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出境医 / 临床实验 / TOngue/Palate Interactions Study (EEXPLORE)

TOngue/Palate Interactions Study (EEXPLORE)

Study Description
Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Toothless Device: Tongue pressure recordings with the PRESLA prothesis for the Arm1 (patients wearing the complete denture for the first time) Device: Tongue pressure recordings with the PRESLA prothesis for the Arm2 (patients used to wear the complete denture) Not Applicable

Detailed Description:

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Experimental Study of Tongue/Palate Interactions Using Upper coMplete dEnture
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: patients with complete denture for the first time
Arm that allows to follow the adaptation of this population to the new complete denture during the tasks of speech production and swallowing.
Device: 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.

Experimental: patients with complete denture used to their complete denture.
Arm that allows a descriptive cross-sectional study of tongue pressure measurements during the tasks of speech production and swallowing
Device: 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.

Outcome Measures
Primary Outcome Measures :
  1. 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 [ Time Frame: Day 0 (Baseline), Week 3 and Month 3 ]
    The evaluation of speech production is based on the characteristics of the pressure and acoustic signals after synchronization during time, using duplicate with up to 8 sensors.

  2. 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 [ Time Frame: Day 0 (Baseline), Week 3 and Month 3 ]
    The evaluation of speech production is based on the characteristics of the pressure and acoustic signals after synchronization during time, using duplicate with up to 8 sensors.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Christophe JEANNIN, PHD 04 27 85 40 32 ext +33 christophe.jeannin@univ-lyon1.fr

Locations
Layout table for location information
France
Service de Consultations et de Traitements Dentaires des Hospices Civils de Lyon
Lyon, France, 69007
Contact: Christophe JEANNIN, PHD    : 04 27 85 40 32 ext +33    christophe.jeannin@univ-lyon1.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Tracking Information
First Submitted Date  ICMJE May 24, 2019
First Posted Date  ICMJE May 29, 2019
Last Update Posted Date May 29, 2019
Estimated Study Start Date  ICMJE September 2019
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2019)
  • 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 [ Time Frame: Day 0 (Baseline), Week 3 and Month 3 ]
    The evaluation of speech production is based on the characteristics of the pressure and acoustic signals after synchronization during time, using duplicate with up to 8 sensors.
  • 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 [ Time Frame: Day 0 (Baseline), Week 3 and Month 3 ]
    The evaluation of speech production is based on the characteristics of the pressure and acoustic signals after synchronization during time, using duplicate with up to 8 sensors.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TOngue/Palate Interactions Study
Official Title  ICMJE Experimental Study of Tongue/Palate Interactions Using Upper coMplete dEnture
Brief Summary 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).
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Toothless
Intervention  ICMJE
  • Device: 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.
  • Device: 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.
Study Arms  ICMJE
  • Experimental: patients with complete denture for the first time
    Arm that allows to follow the adaptation of this population to the new complete denture during the tasks of speech production and swallowing.
    Intervention: Device: Tongue pressure recordings with the PRESLA prothesis for the Arm1 (patients wearing the complete denture for the first time)
  • Experimental: patients with complete denture used to their complete denture.
    Arm that allows a descriptive cross-sectional study of tongue pressure measurements during the tasks of speech production and swallowing
    Intervention: Device: Tongue pressure recordings with the PRESLA prothesis for the Arm2 (patients used to wear the complete denture)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 27, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Christophe JEANNIN, PHD 04 27 85 40 32 ext +33 christophe.jeannin@univ-lyon1.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03966131
Other Study ID Numbers  ICMJE 69HCL18_0103
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospices Civils de Lyon
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP