NCT05096624

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 27, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

February 25, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

July 5, 2023

Status Verified

June 1, 2023

Enrollment Period

2.9 years

First QC Date

October 15, 2021

Last Update Submit

June 30, 2023

Conditions

Disorder of Maxillary and Mandibular Dental Arch Relationship

Keywords

Total bimaxillary edentulous patientDigital DentureNeuromuscular occlusion

Outcome Measures

Primary Outcomes (2)

  • masticatory muscle activity at 1 month of wearing prostheses

    Measurement of muscle activity = measurements will be made for all muscles at rest with and without prostheses.

    1month

  • masticatory muscle balance at 1 month of wearing prostheses

    Muscle balance analysis = comparison of right and left muscle activity.

    1month

Secondary Outcomes (8)

  • number of sessions required to obtain a finalized prosthesis

    1 month

  • quality of life of the patients at 1 month of wearing the prosthesis

    1 month

  • quality of life of the patients at 4 months of wearing the prosthesis

    4 months

  • masticatory muscle activity at the insertion of prostheses in mouth

    at the insertion of prostheses in mouth

  • masticatory muscle activity at 4 months of wearing prostheses

    4 months

  • +3 more secondary outcomes

Study Arms (3)

DD-TENS (Digital Denture-Transcutaneous Electrical Nerve Stimulation)

EXPERIMENTAL

Patient with Complete Removable Prostheses according to DD-TENS system

Other: DD-TENS system

Gold standard

ACTIVE COMPARATOR

Patient with Complete Removable Prostheses according to usual care

Other: Gold Standard

Digital denture System

ACTIVE COMPARATOR

Patient with Complete Removable Prostheses according to Digital Denture system

Other: Digital Denture system

Interventions

DD-TENS systemOTHER

Use of DD-TENS system

DD-TENS (Digital Denture-Transcutaneous Electrical Nerve Stimulation)
Gold StandardOTHER

Gold standard

Gold standard
Digital Denture systemOTHER

Use of Digital Denture system

Digital denture System

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Montpellier

Montpellier, 34295, France

RECRUITING

Study Officials

  • Delphine Carayon, MCU-PH

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Delphine Carayon, MCU-PH

CONTACT

+33467336718d-carayon@chu-montpellier.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2021

First Posted

October 27, 2021

Study Start

February 25, 2022

Primary Completion

February 1, 2025

Study Completion

August 1, 2025

Last Updated

July 5, 2023

Record last verified: 2023-06

Locations

FR(1)