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

NCT06698978 | Not Yet Recruiting

• 1 other identifier: AOR22023
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

removable prosthesis; simplified technique; cross-over; edentulous patients; conventional technique

Outcome Measures

Primary Outcomes (1)

• Variation in total OHIP-20 questionnaire score (Oral Health Impact Profile-20) between inclusion and 3 months after the prosthesis is inserted.

  The OHIP 20 is a scale of oral quality of life, specific to total edentulousness, validated in French. It has 20 items rated from 1 to 6 (minimum score 20-maximum score 120). For each item, a score of 6 corresponds to an optimal quality of life.

  3 months

Secondary Outcomes (5)

• Compare the chair-based completion times between the two prostheses

  up to 4 months

• Compare patient satisfaction for each prosthesis

  11 months

• Compare the quality of prostheses

  11 months

• Compare the cost of simplified restoration with conventional technique, estimate the national impact of the diffusion of simplified technique and estimate the differential cost ratio results

  11 months

• Masticatory performance between the two prostheses

  11 months

Study Arms (2)

Simplified(PS)/Conventional(PC)

OTHER

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: Simplified protocol (PS)/Conventional protocol (PC)

Conventional(PC)/Simplified (PS)

OTHER

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).

Other: Conventional protocol (PC)/Simplified protocol (PS)

Interventions

Simplified protocol (PS)/Conventional protocol (PC) OTHER

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).

Simplified(PS)/Conventional(PC)

Conventional protocol (PC)/Simplified protocol (PS) OTHER

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).

Conventional(PC)/Simplified (PS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years
• Complete single-maxillary (upper or lower arcade) or bimaxillar (upper and lower arcade) edentesis paired with non-iatrogenic removable full dentures (possibly readapted)
• Edentulous arcade with healthy or sanitized mucosa
• Sufficient inter arcade space
• Free and informed consent
• Adequate understanding of written and spoken French
• Membership of a social security scheme

You may not qualify if:

• Patient unable to cooperate
• Presence of pathological lesions of the oral mucosa
• Parkinson's disease
• Gougerot-Sjögren's disease,
• Patient with cancer of the upper aerogribogastic tract
• Patient in psychiatric care
• Patient with neurological disease (vascular algia of the face, trigeminal neuralgia,...)
• Patient with xerostomia
• Allergy identified to resin
• Patient deprived of liberty by judicial or administrative decision
• Patient under legal protection (guardianship, curatorship)
• Patient under AME (State Medical Aid)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Officials

• Christophe RIGNON-BRET

  APHP

  STUDY DIRECTOR

Central Study Contacts

Christophe RIGNON-BRET

CONTACT

06 79 17 67 30; rignonbret@gmail.com

Isabelle FOUILLOUX-PATEY

CONTACT

06 60 67 46 37; Isabelle.fouilloux@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The research consists of two 3-month treatment periods, spaced out by a 1-month wash-out period: Arm with 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) Arm with 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)

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 21, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: November 21, 2024

Record last verified: 2024-10