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Simplified Technique in Removable Complete Prosthesis Versus Conventional Technique in Edentulous Patients

NCT06698978 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2024-11-21

No results posted yet for this study

Summary

This study compares a simplified complete removable denture technique (PS) to the conventional approach (PC) in edentulous patients. The goal is to demonstrate that the simplified technique is not inferior to the conventional method in terms of quality of life, measured by the OHIP-20 scale over three months. The trial also examines time, satisfaction, denture quality, cost, and masticatory performance.

Design:

This is a multicenter, randomized, cross-over study with 62 patients over 11 months of participation, including a one-month washout between treatments. Patients will receive both types of dentures, with the order randomized.

Population:

The trial targets edentulous patients, both uni- and bi-maxillary, aged 18 or older, with certain health and dental conditions.

Key Assessments:

Quality of Life: OHIP-20 scores are collected pre-treatment and after three months for each denture type.

Patient Satisfaction and Denture Quality: Assessed using modified Kapur criteria and patient satisfaction surveys.

Masticatory Performance: Evaluated with a chewing gum test. Medical Economic Impact: Cost analysis of each denture type.

Anticipated Outcomes:

Benefits include reducing costs and treatment times, enhancing accessibility to dentures, particularly for elderly and underserved populations, and adapting dental education to teach this simplified technique.

Centers Involved:

Seven centers across France, including AP-HP hospitals and private practices.

Timeline:

The inclusion period is 24 months, with a total study duration of 35 months.

Conditions

  • Complete Edentulism

Interventions

OTHER

Simplified protocol (PS)/Conventional protocol (PC)

Complete removable denture according to the simplified protocol (PS) in period 1 (3 months), 1 month of wash-out then complete removable denture according to the conventional protocol (PC) in period 2 (3 months).

OTHER

Conventional protocol (PC)/Simplified protocol (PS)

Complete removable denture according to the conventional protocol (PC) in period 1 (3 months), 1 month of wash-out then complete removable denture according to the simplified protocol (PS)in period 2 (3 months).

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Christophe RIGNON-BRET · APHP

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2028-03-01
Completion
2028-03-01

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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 NCT06698978 on ClinicalTrials.gov