Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
NCT ID:
NCT05866835
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
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.
Study:
NCT05866835
Study Brief:
Protocol Section:
NCT05866835