TOngue/Palate Interactions Study (EEXPLORE)

Experimental Study of Tongue/Palate Interactions Using Upper coMplete dEnture

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).

Study Overview

• Status: Recruiting
• Conditions: Toothless
• Intervention / Treatment: 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)

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: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christophe JEANNIN, PHD; Phone Number: +33 04 27 85 40 32; Email: christophe.jeannin@univ-lyon1.fr

Study Locations

• France
  • Lyon, France, 69007
    • Recruiting
    • Service de Consultations et de Traitements Dentaires des Hospices Civils de Lyon
    • Contact: Christophe JEANNIN, PHD; Phone Number: +33 : 04 27 85 40 32; Email: christophe.jeannin@univ-lyon1.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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	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.	Day 0 (Baseline), Week 3 and Month 3

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: May 24, 2019
• First Submitted That Met QC Criteria: May 27, 2019
• First Posted (Actual): May 29, 2019

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: sensors; Speech; complete denture; swallowing
• Other Study ID Numbers: 69HCL18_0103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No