Ventilatory Performances of Athletes During the Use of the Intra-oral ProtectionsNUPPIANCT05866835
Validation of a Digitalised Intraoral Protection
A study testing Manufacture of custom-made IOP, Ventilation tests and Evaluation of comfort level: in people with Ventilatory Performances of Athletes During the Use of the Intra-oral Protections, run by University Hospital, Bordeaux at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Ventilatory Performances of Athletes During the Use of the Intra-oral Protections
- What is being tested?
- Manufacture of custom-made IOP, Ventilation tests and Evaluation of comfort level:
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesFrance
- Study dates
- 10 Oct 2023to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Not yet recruiting
CHU de Bordeaux
Bordeaux
Philippe POISSON, Dr, philippe.poisson@chu-bordeaux.fr
- Recruiting
CREPS de Bordeaux
Bordeaux
Serge LISE, Dr, serge.lise@creps-bordeaux.fr
- Not yet recruiting
Institut national du sport, de l'expertise et de la performance (INSEP)
Paris
Sébastien LE GARREC, Dr, sebastien.legarrec@insep.fr
About this study
Official title: Validation of a Generic Procedure for the Fabrication of a Custom-made Intra-oral Protection Using an Inter-arch Piece
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.
Read more
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
Read the 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:
- 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.
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.
- Being tested
- Manufacture of custom-made IOP, Ventilation tests, Evaluation of comfort level:
- Keywords
- ventilatory performance, athlete, intra-oral protection, protection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manufacture of custom-made IOPOther
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:
- digital recording of the maxillary and mandibular dental arches
- mandibular wedging performed with an inter-arch piece
- digital recording of the inter-arch position
Ventilation testsOther
Realization of a ventilation test (VO2max) to determine the Maximum Aerobic Speed (MAS).
Measurement of ventilatory parameters without IOP and with each IOP :
- At rest, standing still.
- During a 4 minute run on a treadmill at 50% of MAS.
- During a 4-minute run on a treadmill, at a speed corresponding to 70% of MAS
Evaluation of comfort level:Other
Collection from participants (self-questionnaire)
| Study group | Role | What they receive |
|---|---|---|
| Athlete | Experimental | healthy, adult or minor (16 years or older), high-level sportsmen and women, volunteers Receives: Other: Manufacture of custom-made IOP; Other: Ventilation tests; Other: Evaluation of comfort level: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilatory flow per minute
The ventilatory flow rate per minute will be measured during the ventilation test
Measured: 3 weeks (W3) after inclusion (W0)
Secondary outcomes (1)
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.
Measured: 3 weeks (W3) after inclusion (W0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start10 Oct 2023
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilatory Performances of Athletes During the Use of the Intra-oral ProtectionsStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, multi-center experimental study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866835
- Sponsor's protocol ID
- CHUBX 2022/61
- Acronym
- NUPPIA
- Status last verified
- Aug 2025
- First submitted
- 10 May 2023
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Generic Procedure for the Fabrication of a Custom-made Intra-oral Protection Using an Inter-arch Piece
- ClinicalTrials.gov ID
- NCT05866835
- Acronym / sponsor ID
- NUPPIA / CHUBX 2022/61
- Keywords
- ventilatory performance, athlete, intra-oral protection, protection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multi-center experimental study
| Arm | Type | Receives |
|---|---|---|
| Athlete | Experimental | Other: Manufacture of custom-made IOP, Other: Ventilation tests, Other: Evaluation of comfort level:healthy, adult or minor (16 years or older), high-level sportsmen and women, volunteers |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manufacture of custom-made IOPManufacture 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: * digital recording of the maxillary and mandibular dental arches * mandibular wedging performed with an inter-arch piece * digital recording of the inter-arch position | Other | Athlete |
| Ventilation testsRealization of a ventilation test (VO2max) to determine the Maximum Aerobic Speed (MAS). Measurement of ventilatory parameters without IOP and with each IOP : * At rest, standing still. * During a 4 minute run on a treadmill at 50% of MAS. * During a 4-minute run on a treadmill, at a speed corresponding to 70% of MAS | Other | Athlete |
| Evaluation of comfort level:Collection from participants (self-questionnaire) | Other | Athlete |
Primary outcome
Ventilatory flow per minute
Time frame: 3 weeks (W3) after inclusion (W0)
The ventilatory flow rate per minute will be measured during the ventilation test
1 secondary outcome
Confort level
Time frame: 3 weeks (W3) after inclusion (W0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manufacture of custom-made IOP, Ventilation tests and Evaluation of comfort level: in people with Ventilatory Performances of Athletes During the Use of the Intra-oral Protections, run by University Hospital, Bordeaux at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippe POISSON, Dr (0557656590, philippe.poisson@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilatory flow per minute (time frame: 3 weeks (W3) after inclusion (W0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.