Improving chewing function for completely toothless patients using a new dental protocol
Impact of Complete Removable Prosthetic Rehabilitations Performed by an Innovative DDTENS Protocol, on the Quality of Masticatory Function and the Management of Completely Edentulous Patients
This study is testing a new dental treatment to see if it can help completely toothless patients chew better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 60 Years to 85 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT05096624 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of an innovative dental rehabilitation protocol called DDTENS, which combines Digital Denture technology with transcutaneous electrical neurostimulation (TENS) to enhance masticatory function in completely edentulous patients. The research focuses on patients who have previously worn complete removable prostheses and aims to assess improvements in muscle activity and balance after one month of using the new prostheses. By addressing the challenges faced by these patients, the study seeks to improve their overall quality of life and dental function.
Who should consider this trial
Good fit: Ideal candidates for this study are bimaxillary edentulous patients who have previously used complete removable prostheses.
Not a fit: Patients with severe health issues, salivary pathologies, or those under guardianship may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the chewing efficiency and quality of life for patients who are completely edentulous.
How similar studies have performed: While the specific DDTENS protocol is novel, similar approaches combining digital technology and neuromuscular stimulation have shown promise in improving dental rehabilitation outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Bimaxillary edentulous patients * Former bimaxillary CRP wearers (transitional or usage) * Acceptance of the confiscation of the old prosthesis when the new prosthesis is placed in the mouth and during the 4 months the new prosthesis is worn. * Signed informed consent Exclusion Criteria: * Dependent patients (under guardianship or patients in EHPAD) * Heavy pathologies * Salivary pathologies (Gougerot-Sjögren syndrome) or asialia related to a medication. * Patients with a pacemaker * Skeletal class III with an anteroposterior shift of more than 1 cm * Patients under court protection
Where this trial is running
Montpellier
- CHU de Montpellier — Montpellier, France (Recruiting)
Study contacts
- Principal investigator: Delphine Carayon, MCU-PH — University Hospital, Montpellier
- Study coordinator: Delphine Carayon, MCU-PH
- Email: d-carayon@chu-montpellier.fr
- Phone: +33467336718
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.