Evaluation of the Efficacy and Safety of Use of an Innovative Medical Device for Improving Oral Accessibility in People With Disabilities, Presenting Behavioral Disorders: The Oral Accessibility Spatula (Spatule SAB)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 12
- 主要终点
- Visibility and dental examination of incisor-canine sectors, premolars and molars using a probe, assessed by an oral accessibility score determined based on intra oral accessible areas with and without oral accessibility Spatula device
研究概览
简要总结
The purpose of this study is to evaluate the efficiency and the safe use of a new medical device to improve the oral accessibility of disabled people during the oral-dental examination.
详细描述
The oral examination of people with behavioural handicap seems to be difficult. Those patients react with defensive reflexes which limit spontaneously the amplitude of their oral cavity or prevent them to keep open their mouth for a sufficient time to process the examination. This difficulty can be caused by various reasons: cerebral motor disability, behavioral troubles or mental disability, and it affects people of all ages.
The current methods keeping open the mouth like wedges are often unsuitable for those patients. Moreover, no other device exists or is described even in literature. An innovative medical device has to be developed, in order to offer to disabled patients and the users or dentists a comfort during the oral-dental examination.
The oral accessibility spatula, made out polypropylene plastic, is designed into two parts :
- a handle to hold the spatula by the user
- a thin plastic surface introduced into the mouth, which is dull with a round edge and has holes on the sides to lock the spatula between the upper and lower teeth.
Primary objective :
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mental disability patient with behavioural troubles known or noticed during the approach of hand for dental examination
- •Venham Scale score of 2 and higher, meaning opposing, after an approach toward the oral cavity
- •Information of the responsible person for the patient, if necessary, and followed by the dated signed informed consent
排除标准
- •pregnant or nursing woman
- •lack of social security
- •people under guardianship
研究组 & 干预措施
Disabled People with behavioral trouble
干预措施: oral accessibility spatula (SAB) (Device)
结局指标
主要结局
Visibility and dental examination of incisor-canine sectors, premolars and molars using a probe, assessed by an oral accessibility score determined based on intra oral accessible areas with and without oral accessibility Spatula device
时间窗: 1 day
score of 0 = no access to 12 = total accessibility
次要结局
- The safety of the spatula will be assessed by analyzing the reported adverse effects and their relative frequency(1 day)
- The dental exam tolerance evaluation with and without Oral Accessibility Spatula(1 day)