Validation of a Generic Procedure for the Fabrication of a Custom-made Intra-oral Protection Using an Inter-arch Piece
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Ventilatory flow per minute
研究概览
简要总结
Type III (custom-made) intra-oral protection (IOP) models represent 13% of IOP worn by amateur rugby club players in France.
However, this model is recognized as the most effective when made in accordance with essential health and safety requirements.
This observation is at the origin of a new approach that the investigators are proposing with the objective of removing the barriers to access to custom-made IOP. This research is based on the combination of new digital technologies, scanning and 3D printing, to develop a new generation of IOP.
This project aims to show the interest of this new generation of "modified unimaxillary" IOP on the ventilation of the athletes and his/her comfort when he/she evolves with his IOP in place
详细描述
Type III (custom) Intra Oral Protection (IOP) models represent 13% of IOP worn by amateur rugby players in France.
However, this model is recognized as the most effective when made in accordance with essential health and safety requirements.
This under-utilization can be explained by the existence of many barriers to the diffusion of custom-made IOP:
- Organizational barrier: long fabrication procedure (minimum 3 sessions) requiring qualified people (dental surgeon, dental technician), trained in the technique of making custom IOP and in essential health and safety criteria.
- Financial barrier: high cost with a selling price of 200€ to 300€ per unit.
- Technical barriers:
- Difficulties in making custom-made IOP for athletes who wear fixed braces (brackets and wire),
- Difficulties in improving the impact energy dissipation capacity without affecting the absorption capacity of the custom-made IOP,
- Difficulties in individualizing and characterizing the IOP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects between the ages of 16 and 35,
- •Subject affiliated to a social security system,
- •Subject affiliated with the French Federation of Boxing or Rugby or Football
- •Subject having signed a consent form
- •For minors, legal guardians having signed the free and informed consent form
排除标准
- •Subject with a pathology incompatible with the realization of the trial:
- •Absolute contraindications: Recent infarction (wait 5 to 12 days depending on severity), Threat syndrome (lawful test after stabilization - at least 3 days without spontaneous seizures), Resting BP > 200/120 mmHg, Uncompensated heart failure, Third-degree Atrioventricular block, Myocarditis, Pericarditis, Endocarditis, Aortic Dissection, Intracardiac tumor or thrombus, Deep venous thrombosis, Pulmonary Embolism,
- •Relative contraindications: Aortic stenosis (formal contraindication if lipothymia, syncope or signs of heart failure), Severe non-revascularized coronary artery disease, Pulmonary arterial hypertension (formal contraindication if primary), Severe rapid ventricular or supraventricular arrhythmias
- •Subject under B-mimetic drug treatment,
- •Subject with decaying teeth,
- •Subject under court protection,
- •Subject participating in another research study,
- •Subject in pregnancy.
结局指标
主要结局
Ventilatory flow per minute
时间窗: 3 weeks (W3) after inclusion (W0)
The ventilatory flow rate per minute will be measured during the ventilation test
次要结局
- Confort level(3 weeks (W3) after inclusion (W0))