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

Summary

Total edentulism is a profound physical, psychic and social handicap, which affects 5 million people in France. The most frequent complaint of edentulous patients rehabilitated by conventional Complete Removable Prostheses (CRP) is the reduction of masticatory efficiency. This alteration has medical repercussions and a negative psychological and social impact.

Our study aims to evaluate the impact of an innovative protocol on the quality of masticatory function, prosthetic treatment and, in fact, on the quality of life of the totally edentulous patient. This protocol combines the Digital Denture system with the transcutaneous electrical neurostimulation system (TENS®), in order to improve the balance of the dento-dental contacts of CRP. This new protocol is called DDTENS.

The first objective of the study is to compare the activity and balance of the masticatory muscles at 1 month (T1) of wearing the prostheses, between an experimental group benefiting from a CRP by the DDTENS protocol and 2 reference groups ( the first benefiting from a CRP by the conventional procedure and the second by the Digital Denture procedure) in bimaxillary total edentulous patients

The secondary objectives are:

* to compare the number of sessions required to obtain a finalized bimaxillary total removable prosthesis between the 3 groups.
* to compare the quality of life of patients with their CRP between the 3 groups, at 1 month and 4 months of wearing the prostheses.
* to compare the activity and balance of the masticatory muscles when the prostheses were put in the mouth (T0) and at 4 months (T4) of wearing the prostheses

The study design is a randomised open-label controlled pilot study with blinded reviewer assessment comparing 3 parallel groups:

* Experimental group: 10 bimaxillary edentulous patients rehabilitated by CRP using the DDTENS protocol.
* Control group 1: 10 edentulous bimaxillary patients rehabilitated by CRP according to the conventional method (gold standard technique).
* Control group 2: 10 edentulous bimaxillary patients rehabilitated by CRP using the Digital Denture procedure.

The expected benefits for patients in the DDTENS experimental group are the optimization of occlusal balance, the optimization of the time of integration of the prosthesis in the mouth, the time saving in the prosthetic treatment of the edentulous patient and the improvement of eating behaviours and quality of life of edentulous patients which would delay the entry of our patients into the sphere of dependence.

These results would allow the validation of a new rehabilitation protocol for the edentulous patient, leading to a modification of clinical practices.

Conditions

• Disorder of Maxillary and Mandibular Dental Arch Relationship

Interventions

OTHER

DD-TENS system

Use of DD-TENS system

OTHER

Gold Standard

Gold standard

OTHER

Digital Denture system

Use of Digital Denture system

Sponsors & Collaborators

• University Hospital, Montpellier

  lead OTHER

Principal Investigators

• Delphine Carayon, MCU-PH · University Hospital, Montpellier

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-02-25

Primary Completion

2025-02-28

Completion

2025-08-31

Countries

• France

Study Locations