Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
Study NCT ID:
NCT05866835
Status:
RECRUITING
Last Update Posted:
2025-08-08
First Post:
2023-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of a Digitalised Intraoral Protection
Sponsor:
University Hospital, Bordeaux
Organization:
Study Overview
Official Title:
Validation of a Generic Procedure for the Fabrication of a Custom-made Intra-oral Protection Using an Inter-arch Piece
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NUPPIA
Brief Summary:
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
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
Detailed Description:
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:
1. 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.
2. Financial barrier: high cost with a selling price of 200€ to 300€ per unit.
3. 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.
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 :
* A simpler and shorter procedure,
* A target price accepted by athletes,
* "French Association for Standardization"(AFNOR) standards guaranteed,
* Compatibility with fixed orthodontic treatments,
* Ability to develop new protection strategies,
* Ability to improve the athlete's comfort. Currently, the IOP resulting from these technologies are mainly "unimaxillary", i.e. without engagement of the mandibular dental arch and without ventilation space. In order to comply with the Afnor XP S72-427 standard, the project proposes the fabrication of two models of "modified unimaxillary" IOP that ensure the engagement of the mandibular dental arch and the creation of a ventilation space at two different heights, 4mm and 6mm. This project aims to show the interest of this new generation of "modified unimaxillary" IOP on the athlete's ventilation and his comfort when he evolves with his IOP in place. It is based on a population of men and women, minors and adults, practicing a sport at risk of oral trauma and uses a methodology already proven by the research team.
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:
1. 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.
2. Financial barrier: high cost with a selling price of 200€ to 300€ per unit.
3. 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.
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 :
* A simpler and shorter procedure,
* A target price accepted by athletes,
* "French Association for Standardization"(AFNOR) standards guaranteed,
* Compatibility with fixed orthodontic treatments,
* Ability to develop new protection strategies,
* Ability to improve the athlete's comfort. Currently, the IOP resulting from these technologies are mainly "unimaxillary", i.e. without engagement of the mandibular dental arch and without ventilation space. In order to comply with the Afnor XP S72-427 standard, the project proposes the fabrication of two models of "modified unimaxillary" IOP that ensure the engagement of the mandibular dental arch and the creation of a ventilation space at two different heights, 4mm and 6mm. This project aims to show the interest of this new generation of "modified unimaxillary" IOP on the athlete's ventilation and his comfort when he evolves with his IOP in place. It is based on a population of men and women, minors and adults, practicing a sport at risk of oral trauma and uses a methodology already proven by the research team.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: