Impact of Complete Removable Prosthetic Rehabilitations Performed by an Innovative DDTENS Protocol, on the Quality of Masticatory Function and the Management of Completely Edentulous Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- masticatory muscle balance at 1 month of wearing prostheses
研究概览
简要总结
Total edentulism is a profound physical, psychic and social handicap, which affects 5 million people in France. The most frequent complaint of edentulous patients rehabilitated by conventional Complete Removable Prostheses (CRP) is the reduction of masticatory efficiency. This alteration has medical repercussions and a negative psychological and social impact.
Our study aims to evaluate the impact of an innovative protocol on the quality of masticatory function, prosthetic treatment and, in fact, on the quality of life of the totally edentulous patient. This protocol combines the Digital Denture system with the transcutaneous electrical neurostimulation system (TENS®), in order to improve the balance of the dento-dental contacts of CRP. This new protocol is called DDTENS.
The first objective of the study is to compare the activity and balance of the masticatory muscles at 1 month (T1) of wearing the prostheses, between an experimental group benefiting from a CRP by the DDTENS protocol and 2 reference groups ( the first benefiting from a CRP by the conventional procedure and the second by the Digital Denture procedure) in bimaxillary total edentulous patients
The secondary objectives are:
- to compare the number of sessions required to obtain a finalized bimaxillary total removable prosthesis between the 3 groups.
- to compare the quality of life of patients with their CRP between the 3 groups, at 1 month and 4 months of wearing the prostheses.
- to compare the activity and balance of the masticatory muscles when the prostheses were put in the mouth (T0) and at 4 months (T4) of wearing the prostheses
The study design is a randomised open-label controlled pilot study with blinded reviewer assessment comparing 3 parallel groups:
- Experimental group: 10 bimaxillary edentulous patients rehabilitated by CRP using the DDTENS protocol.
- Control group 1: 10 edentulous bimaxillary patients rehabilitated by CRP according to the conventional method (gold standard technique).
- Control group 2: 10 edentulous bimaxillary patients rehabilitated by CRP using the Digital Denture procedure.
The expected benefits for patients in the DDTENS experimental group are the optimization of occlusal balance, the optimization of the time of integration of the prosthesis in the mouth, the time saving in the prosthetic treatment of the edentulous patient and the improvement of eating behaviours and quality of life of edentulous patients which would delay the entry of our patients into the sphere of dependence.
These results would allow the validation of a new rehabilitation protocol for the edentulous patient, leading to a modification of clinical practices.
详细描述
EPIDEMIOLOGY Total edentulism is defined by the total absence of teeth. It can be uni or bimaxillary and represents a profound physical, psychic and social handicap, affecting 5 million people in France. Despite progress in prophylaxis, the number of patients with total edentulism is constantly increasing.
There are several explanations for this phenomenon in France:
- Increase in life expectancy According to INSEE, life expectancy in France will increase from 75.2 years to 89.5 years for men and from 82.7 to 93 years for women between 2000 and 2050.
- Social precarity Social precarity is a societal problem that explains the delay or lack of dental care, leading to a higher rate of total edentulism among the most disadvantaged social class populations. Lifestyle behaviors such as smoking and alcohol consumption worsen this situation.
- Ageing of the population The arrival of the baby boomers in the 60+ age group and the increase in life expectancy explain the inevitable ageing of the population (3). People aged over 60 are expected to represent 1/3 of the population in 2050, whereas in 2005 they represented only 1/5.
This ageing is often associated with an alteration in physical and intellectual faculties. The relative well-being of 60-75 year old is gradually giving way to frailty. The challenge is to care for increasingly elderly edentulous patients. It is therefore essential to develop prosthetic rehabilitation practices to improve patient comfort.
Adopting an adapted treatment by limiting the number of appointments while maintaining an optimal quality of care is one of the objectives of our project.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Bimaxillary edentulous patients
- •Former bimaxillary CRP wearers (transitional or usage)
- •Acceptance of the confiscation of the old prosthesis when the new prosthesis is placed in the mouth and during the 4 months the new prosthesis is worn.
- •Signed informed consent
排除标准
- •Dependent patients (under guardianship or patients in EHPAD)
- •Heavy pathologies
- •Salivary pathologies (Gougerot-Sjögren syndrome) or asialia related to a medication.
- •Patients with a pacemaker
- •Skeletal class III with an anteroposterior shift of more than 1 cm
- •Patients under court protection
结局指标
主要结局
masticatory muscle balance at 1 month of wearing prostheses
时间窗: 1month
Muscle balance analysis = comparison of right and left muscle activity.
masticatory muscle activity at 1 month of wearing prostheses
时间窗: 1month
Measurement of muscle activity = measurements will be made for all muscles at rest with and without prostheses.
次要结局
- quality of life of the patients at 1 month of wearing the prosthesis(1 month)
- number of sessions required to obtain a finalized prosthesis(1 month)
- quality of life of the patients at 4 months of wearing the prosthesis(4 months)
- masticatory muscle balance at the insertion of prostheses in mouth(at the insertion of prostheses in mouth)
- masticatory muscle activity at the insertion of prostheses in mouth(at the insertion of prostheses in mouth)
- masticatory muscle balance at 4 months of wearing prostheses(4 months)
- Analysis of the chronology of muscle contraction on the right and left(1 month)
- masticatory muscle activity at 4 months of wearing prostheses(4 months)