| NCT ID | NCT03966131 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Toothless |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-02-02 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-02-02 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03966131 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Toothless. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03966131 currently recruiting?
Yes, NCT03966131 is actively recruiting participants. Contact the research team at christophe.jeannin@univ-lyon1.fr for enrollment information.
Where is the NCT03966131 trial being conducted?
This trial is being conducted at Lyon, France.
Who is sponsoring the NCT03966131 clinical trial?
NCT03966131 is sponsored by Hospices Civils de Lyon. The trial plans to enroll 60 participants.