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Impact of Removable Versus Fixed Implant-supported Prostheses in Oral Health Quality of Life for Edentulous Patients

NCT05162963 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-12-20

No results posted yet for this study

Summary

Comparison between fixed and removable implant-retained complete prostheses previously showed that while patients appreciate the ergonomic cleaning of removable prostheses, they prefer the comfort and masticatory efficiency of fixed prostheses. New treatment strategies are emerging; the use of telescopic attachments now offers a prosthetic alternative for the treatment of edentulous teeth at a lower financial cost than fixed prostheses.

To answer this question, the study is constructed as a cross-over. 30 patients will use a removable telescopic prosthesis and then a fixed prosthesis, or vice versa, for a period of 6 months according to randomization. They will answer a quality of life questionnaire after each period and finally choose their favorite prosthesis. The null hypothesis is that removable telescopic implant prostheses will result in a quality of life comparable to that obtained with fixed implant-supported prostheses.

The primary objective of this study is to demonstrate the non-inferiority of removable versus fixed prostheses on quality of life after 6 months of use of each implant-supported prosthesis in edentulous maxillary or mandibular patients. The measurement of the evolution of the quality of life is analyzed using the GOHAI questionnaire after 6 months of use of each prosthesis.

The secondary objectives are to:

* Determine the decisional parameters in the final choice of the prosthesis by the patient at the end of the study, with the Mc Gill Denture Satisfaction Instrument,
* Compare the masticatory efficiency between the two dentures (duration, number of cycles and frequency of chewing of the carrot test food, with each denture after 6 months of use),
* Compare the oral hygiene between the two prostheses (peri-implant plaque index, after 6 months for each prosthesis),
* Compare the adjustments and repair required after the placement of each prosthesis and the chairside treatment time to achieve them,
* Compare the complications and their frequency of occurrence with each type of prosthesis during the 6-month wearing period.

Conditions

  • Complete Edentulism

Interventions

OTHER

fixed implant denture

Patients will receive four or six dental implants, four in the mandible or six in the maxilla, depending on the arch to be treated. After an osseointegration phase of 4 to 6 months, two implant prostheses will be made for each patient, one removable, the other fixed. According to the randomization, during an initial period of 6 months, half of the patients will be using the removable prosthesis, the other half the fixed prosthesis. A 15-day washout will be performed. Then, during a second period of 6 months, the patients will be using the second prosthesis.

OTHER

removable implant denture

removable implant denture

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2024-04-01
Completion
2025-05-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05162963 on ClinicalTrials.gov