Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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:
This observation is at the origin of a new approach proposed in order to remove the barriers to access to custom IOP. Naturally, this project relies on the combination of new digital technologies, scanning and 3D printing, to develop a new generation IOP with :
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Athlete | Experimental | healthy, adult or minor (16 years or older), high-level sportsmen and women, volunteers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manufacture of custom-made IOP | Other | Manufacture of custom-made "unimaxillary" and "modified unimaxillary" intra-oral protection (IOP) with vertical dimensions of 4 mm and 6 mm. 3D modeling of a IOP based on:
|
| Measure | Description | Time Frame |
|---|---|---|
| Ventilatory flow per minute | The ventilatory flow rate per minute will be measured during the ventilation test | 3 weeks (W3) after inclusion (W0) |
| Measure | Description | Time Frame |
|---|---|---|
| Confort level | For the evaluation of the comfort level of wearing the IOP, eleven judgement criteria are proposed and evaluated using a visual analogue scale graduated from 0 (uncomfortable) to 10 (very comfortable): retention, muco-gingival aspect, height of mouth opening, volume of the PIB, nausea, phonation, open mouth ventilation, clenched jaw ventilation, salivation, masticatory muscles, temporomandibular joint. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Subject with a pathology incompatible with the realization of the trial:
Subject under B-mimetic drug treatment,
Subject with decaying teeth,
Subject under court protection,
Subject participating in another research study,
Subject in pregnancy.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philippe POISSON, Dr | Contact | 0557656590 | philippe.poisson@chu-bordeaux.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Not yet recruiting | Bordeaux | France |
Not provided
| ID | Term |
|---|---|
| D012123 | Pulmonary Ventilation |
| ID | Term |
|---|---|
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Prospective, multi-center experimental study
Not provided
Not provided
Not provided
Not provided
|
| Ventilation tests | Other | Realization of a ventilation test (VO2max) to determine the Maximum Aerobic Speed (MAS). Measurement of ventilatory parameters without IOP and with each IOP :
|
|
| Evaluation of comfort level: | Other | Collection from participants (self-questionnaire) |
|
| 3 weeks (W3) after inclusion (W0) |
| CREPS de Bordeaux | Recruiting | Bordeaux | France |
|
| Institut national du sport, de l'expertise et de la performance (INSEP) | Not yet recruiting | Paris | France |
|
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |