ToothlessEEXPLORENCT03966131
TOngue/Palate Interactions Study
A study testing Tongue pressure recordings with the PRESLA prothesis for the Arm1 (patients wearing the complete denture for the first time) and Tongue pressure recordings with the PRESLA prothesis for the Arm2 (patients used to wear the complete denture) in people with Toothless, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Toothless
- What is being tested?
- Tongue pressure recordings with the PRESLA prothesis for the Arm1 (patients wearing the complete denture for the first time) and Tongue pressure recordings with the PRESLA prothesis for the Arm2 (patients used to wear the complete denture)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2024to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Consultations et de Traitements Dentaires des Hospices Civils de Lyon
Lyon, 69007
Christophe JEANNIN, PHD, : 04 27 85 40 32 ext. +33, christophe.jeannin@univ-lyon1.fr
About this study
Official title: 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).
Read the 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.
- Conditions
- Toothless
- Being tested
- Tongue pressure recordings with the PRESLA prothesis for the Arm1 (patients wearing the complete denture for the first time), Tongue pressure recordings with the PRESLA prothesis for the Arm2 (patients used to wear the complete denture)
- Keywords
- Speech, swallowing, sensors, complete denture
- Medical subject headings
- Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tongue pressure recordings with the PRESLA prothesis for the Arm1 (patients wearing the complete denture for the first time)Device
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.
Tongue pressure recordings with the PRESLA prothesis for the Arm2 (patients used to wear the complete denture)Device
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 group | Role | What they receive |
|---|---|---|
| patients with complete denture for the first time | Experimental | Arm that allows to follow the adaptation of this population to the new complete denture during the tasks of speech production and swallowing. Receives: Device: Tongue pressure recordings with the PRESLA prothesis for the Arm1 (patients wearing the complete denture for the first time) |
| patients with complete denture used to their complete denture. | Experimental | Arm that allows a descriptive cross-sectional study of tongue pressure measurements during the tasks of speech production and swallowing Receives: Device: Tongue pressure recordings with the PRESLA prothesis for the Arm2 (patients used to wear the complete denture) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 0 (Baseline), Week 3 and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start2 Feb 2024
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ToothlessStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966131
- Sponsor's protocol ID
- 69HCL18_0103
- Acronym
- EEXPLORE
- Status last verified
- Feb 2024
- First submitted
- 24 May 2019
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Study of Tongue/Palate Interactions Using Upper coMplete dEnture
- ClinicalTrials.gov ID
- NCT03966131
- Acronym / sponsor ID
- EEXPLORE / 69HCL18_0103
- Conditions
- Toothless
- Keywords
- Speech, swallowing, sensors, complete denture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 29 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with complete denture for the first time | Experimental | Device: Tongue pressure recordings with the PRESLA prothesis for the Arm1 (patients wearing the 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. |
| patients with complete denture used to their complete denture. | Experimental | Device: Tongue pressure recordings with the PRESLA prothesis for the Arm2 (patients used to wear the complete denture)Arm that allows a descriptive cross-sectional study of tongue pressure measurements during the tasks of speech production and swallowing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | patients with complete denture for the first time |
| 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. | Device | patients with complete denture used to their complete denture. |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: No
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Edentulous Jaw, Tooth Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tongue pressure recordings with the PRESLA prothesis for the Arm1 (patients wearing the complete denture for the first time) and Tongue pressure recordings with the PRESLA prothesis for the Arm2 (patients used to wear the complete denture) in people with Toothless, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christophe JEANNIN, PHD (04 27 85 40 32 ext. +33, christophe.jeannin@univ-lyon1.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.