Assessing the impact of complete dentures on speech and swallowing
Experimental Study of Tongue/Palate Interactions Using Upper coMplete dEnture
This study tests how new complete dentures affect speech and swallowing in people who have lost all their teeth, comparing those who are new to dentures with those who have been using them for over a year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Lyon) |
| Trial ID | NCT03966131 on ClinicalTrials.gov |
What this trial studies
This project evaluates how new complete dentures affect speech production and swallowing in edentulous patients. Using sensors placed in a duplicate prosthesis, the study measures pressure and acoustic signals during speech and swallowing tasks. The research focuses on two groups: those wearing dentures for the first time and those who have been using them for over a year. The data collected will help map the mechanical pressures exerted by the tongue on the palate, providing insights into the functional outcomes of denture use.
Who should consider this trial
Good fit: Ideal candidates are bimaxillary edentulous patients over 18 years old requiring a prosthesis or those who have had a prosthesis for at least one year.
Not a fit: Patients with speech or neurological disorders, or those who are not native French speakers, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the design and functionality of complete dentures, enhancing speech and swallowing for patients.
How similar studies have performed: While similar studies have explored denture impacts, this specific approach using sensor technology for detailed pressure mapping is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lyon
- Service de Consultations et de Traitements Dentaires des Hospices Civils de Lyon — Lyon, France (Recruiting)
Study contacts
- Study coordinator: Christophe JEANNIN, PHD
- Email: christophe.jeannin@univ-lyon1.fr
- Phone: 04 27 85 40 32
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.