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.
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
Patient unable to cooperate
Presence of pathological lesions of the oral mucosa
Parkinson's disease
Gougerot-Sjögren's disease,
Crossover
Simplified protocol (PS)/Conventional protocol (PC)
Other interventionComplete 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).
Conventional protocol (PC)/Simplified protocol (PS)
Other interventionComplete 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).
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.
Compare the chair-based completion times between the two prostheses
Measurement of time spent (in minutes) at the chair for the stages of prosthesis construction and adjustment
Compare patient satisfaction for each prosthesis
Measurement of patient satisfaction on different items for each prosthesis using the Celebic and Knezovic-Zlataric questionnaire (Grade 1 to 5:Grade 1 Insufficient, Grade 2 Fair,Grade 3 Good, Grade 4 Very good, Grade 5 Excellent ) at the beginning of each sequence and after 3 months of wearing each prosthesis
Compare the quality of prostheses
Measurement of prosthesis quality according to the Kapur score Modified (retention: 0 to 2; stability: 0 to 3)
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
compare the full cost of manufacturing each prosthesis
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