Interest of a Simplified Technique in Removable Complete Prosthesis Versus Conventional Technique in Edentulous Patients: a Multicenter Randomized Clinical Trial in Cross-over.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 62
- 主要终点
- Variation in total OHIP-20 questionnaire score (Oral Health Impact Profile-20) between inclusion and 3 months after the prosthesis is inserted.
研究概览
简要总结
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.
详细描述
Despite the progress made in preventing caries and periodontal disease, edentury remains a major disability affecting function, nutrition, aesthetics and quality of life. In France, there were about two million edentulous in 2003 (HAS). It is estimated that the proportion of single-maxillary edentulous people in 65-74 years was 16.3% and 14.3% for bimaxillary edentulum. The population of complete edentulous is a fragile, often elderly population at risk of undernutrition and social isolation.
Since January 2021, the CCAM has imposed a RAC0 (remaining charge 0) for complete removable prostheses (PAC) with capped fees. These blocked fees make it difficult to produce high quality prostheses according to the conventional protocol. The blocked fees encourage liberal dentists to refer these patients to medical centres or hospital services. In addition, in areas of medical desertification, a shorter treatment time would be beneficial for patients and practitioners.
During the last five years, international literature has brought out simplified protocols to achieve PACs, shorter and more economical than conventional protocols. According to these studies there is no significant difference in quality of life for completely edentulous patients. However, these simplified AHRC implementation protocols are not harmonized and the simplification does not involve the same steps according to the protocols or the same classes of complete edentulous. In addition, these simplified protocols are not taught because they are too recent and with insufficient evidence from well-conducted clinical trials.
The hypothesis is that a new prosthetic realization technique with a single imprint, according to an innovative protocol, is not inferior in terms of quality of life than the conventional realization technique with two impressions in PAC.
The main objective of this study is to demonstrate the non-inferiority of a complete removable prosthesis made according to the simplified protocol compared to a complete removable prosthesis made according to the conventional protocol on quality of life, after 3 months of use of each prosthesis, in patients with complete single-maxillary or bi-maxillary edentesis (upper and/or lower arcada).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Simplified(PS)/Conventional(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).
干预措施: Simplified protocol (PS)/Conventional protocol (PC) (Other)
Conventional(PC)/Simplified (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).
干预措施: Conventional protocol (PC)/Simplified protocol (PS) (Other)
结局指标
主要结局
Variation in total OHIP-20 questionnaire score (Oral Health Impact Profile-20) between inclusion and 3 months after the prosthesis is inserted.
时间窗: 3 months
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.
次要结局
- 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)