Oral ManifestationsENORMPIBANCT04056559
Normative Assessment of Adaptable Mouthguards.
A study testing Adaptable mouthguards in people with Oral Manifestations, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The aim of this study is to the validate adaptable mouthguards prototypes, patented by Bordeaux University and Bordeaux University Hospital. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Manifestations
- What is being tested?
- Adaptable mouthguards
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2011to 29 Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject aged 18 to 35,
- Subject affiliated to a social security,
- Subject who has signed the free and informed consent form.
Who cannot join
- Subject with a pathology incompatible with the performance of the test, namely: Recent infarction,Threat syndrome, blood pressure resting> 200/120 mmHg, uncompensated cardiac insufficiency, atrioventricular block 3rd degree acquired, Myocarditis, Pericarditis, Endocarditis, Aortic Dissection, Intracardiac Tumor or Thrombus, Deep Vein Thrombosis, Pulmonary Embolism,
- Subject under B-mimetic drug treatment,
- Subject under safeguard of justice,
- Subject participating in another search,
- Subject during pregnancy.
Trial locations and contacts
1 site in 1 country.
France1 site
CHU de Bordeaux - Pôle Médecine et chirurgie bucco-dentaire
Bordeaux, 33000
About this study
The aim of this study is to the validate adaptable mouthguards prototypes, patented by Bordeaux University and Bordeaux University Hospital.
Read the detailed description
The current state of knowledge in the areas of mouthguards shows that type II (adaptable) models account for 90% of the mouthguards of the sporting population. But a majority of these devices do not appear to comply with the European Directive 89/686 / European Economic Community.
A previous work consisted of the production of prototypes of mouthguards meeting the essential requirements of the directive. These prototypes were the subject of a patent filed by the Bordeaux University and the Bordeaux University Hospital.
The aim of this study is to the validate the prototypes for a future launch on the market.
- Conditions
- Oral Manifestations
- Being tested
- Adaptable mouthguards
- Keywords
- Prototype, Adaptable mouthguards
- Medical subject headings
- Oral Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptable mouthguardsDevice
Validate a prototype of Adaptable Intra-Oral Protections patented by Bordeaux University and Bordeaux University Hospital according to 3 levels (ventilation, comfort, cervical muscle activity).
| Study group | Role | What they receive |
|---|---|---|
| SIngle arm | Experimental | The research is based on a population of men and women practicing a sport at risk of oral trauma. Receives: Device: Adaptable mouthguards |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact on ventilatory flow rate by minute
Average of measured values in one minute, compared to maximum aerobic reference speed of the subject
Modification of the ventilatory flow rate by min
Measured: At Week 51
Impact on O2 consumption
Average of measured values in one minute, compared to reference of the subject
Measured: At Week 51
Impact on respiratory rate
Average of measured values in one minute, compared to reference of the subject
Measured: At Week 51
Impact on current volume
Average of measured values in one minute, compared to reference of the subject
Measured: At Week 51
Impact on CO2 production
Average of measured values in one minute, compared to reference of the subject
Measured: At Week 51
Impact on comfort according an analogical visual scale for 11 criteria
According an analogical visual scale (from 0 to 10) for 11 criteria (retention, muco-gingival appearance, mouth opening height, volume of mouthguards, nausea, phonation, open mouth ventilation, tight jaw ventilation, salivation, masticatory muscles, temporomandibular joint)
Measured: At Week 51
Impact on electromyographic recording
The electromyographic activity will be amplified and filtered (bandwidth 10-1000 Hz). The signals will be digitized using a CED 1401 interface coupled to a microcomputer that is controlled by the "SPIKE2" software. The digitization frequency will be 2,000 Hz. The software "SPIKE2" will then calculate what is called "integrated electromyogram": the electromyographic signals will be rectified and filtered with a moving average having a period of 0,2 seconds.
Measured: At Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start9 Sep 2011
- Primary completion29 Jun 2012
- Study completion29 Jun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral ManifestationsStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe POISSON, Dr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056559
- Sponsor's protocol ID
- CHU Bx 2011/04
- Acronym
- ENORMPIBA
- Status last verified
- Aug 2019
- First submitted
- 13 Aug 2019
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guerard S, Barou JL, Petit J, Poisson P. Characterization of mouth-formed mouthguards: thermal performance. Dent Mater J. 2014;33(6):799-804. doi: 10.4012/dmj.2014-044. Epub 2014 Oct 11.
PubMed 25311336
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normative Assessment of Adaptable Mouthguards.
- ClinicalTrials.gov ID
- NCT04056559
- Acronym / sponsor ID
- ENORMPIBA / CHU Bx 2011/04
- Conditions
- Oral Manifestations
- Keywords
- Prototype, Adaptable mouthguards
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 9 Sep 2011 (actual)
- Primary completion
- 29 Jun 2012 (actual)
- Study completion
- 29 Jun 2012 (actual)
- First posted
- 14 Aug 2019 (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.
The aim of this study is to the validate adaptable mouthguards prototypes, patented by Bordeaux University and Bordeaux University Hospital.
Detailed description
The current state of knowledge in the areas of mouthguards shows that type II (adaptable) models account for 90% of the mouthguards of the sporting population. But a majority of these devices do not appear to comply with the European Directive 89/686 / European Economic Community.
A previous work consisted of the production of prototypes of mouthguards meeting the essential requirements of the directive. These prototypes were the subject of a patent filed by the Bordeaux University and the Bordeaux University Hospital.
The aim of this study is to the validate the prototypes for a future launch on the market.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single
| Arm | Type | Receives |
|---|---|---|
| SIngle arm | Experimental | Device: Adaptable mouthguardsThe research is based on a population of men and women practicing a sport at risk of oral trauma. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subject aged 18 to 35,
- Subject affiliated to a social security,
- Subject who has signed the free and informed consent form.
Key exclusion criteria (5 listed)
- Subject with a pathology incompatible with the performance of the test, namely: Recent infarction,Threat syndrome, blood pressure resting> 200/120 mmHg, uncompensated cardiac insufficiency, atrioventricular block 3rd degree acquired, Myocarditis, Pericarditis, Endocarditis, Aortic Dissection, Intracardiac Tumor or Thrombus, Deep Vein Thrombosis, Pulmonary Embolism,
- Subject under B-mimetic drug treatment,
- Subject under safeguard of justice,
- Subject participating in another search,
- Subject during pregnancy.
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 |
|---|---|---|
| Adaptable mouthguardsValidate a prototype of Adaptable Intra-Oral Protections patented by Bordeaux University and Bordeaux University Hospital according to 3 levels (ventilation, comfort, cervical muscle activity). | Device | SIngle arm |
Primary outcome
Impact on ventilatory flow rate by minute
Time frame: At Week 51
Average of measured values in one minute, compared to maximum aerobic reference speed of the subject Modification of the ventilatory flow rate by min
Impact on O2 consumption
Time frame: At Week 51
Average of measured values in one minute, compared to reference of the subject
Impact on respiratory rate
Time frame: At Week 51
Average of measured values in one minute, compared to reference of the subject
Impact on current volume
Time frame: At Week 51
Average of measured values in one minute, compared to reference of the subject
Impact on CO2 production
Time frame: At Week 51
Average of measured values in one minute, compared to reference of the subject
Impact on comfort according an analogical visual scale for 11 criteria
Time frame: At Week 51
According an analogical visual scale (from 0 to 10) for 11 criteria (retention, muco-gingival appearance, mouth opening height, volume of mouthguards, nausea, phonation, open mouth ventilation, tight jaw ventilation, salivation, masticatory muscles, temporomandibular joint)
Impact on electromyographic recording
Time frame: At Week 52
The electromyographic activity will be amplified and filtered (bandwidth 10-1000 Hz). The signals will be digitized using a CED 1401 interface coupled to a microcomputer that is controlled by the "SPIKE2" software. The digitization frequency will be 2,000 Hz. The software "SPIKE2" will then calculate what is called "integrated electromyogram": the electromyographic signals will be rectified and filtered with a moving average having a period of 0,2 seconds.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Results publication: PubMed 25311336Guerard S, Barou JL, Petit J, Poisson P. Characterization of mouth-formed mouthguards: thermal performance. Dent Mater J. 2014;33(6):799-804. doi: 10.4012/dmj.2014-044. Epub 2014 Oct 11.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Philippe POISSON, Dr principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptable mouthguards in people with Oral Manifestations, run by University Hospital, Bordeaux at 1 site 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact on ventilatory flow rate by minute (time frame: At Week 51). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04056559, which also lists 1 linked publication.
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 18 Jun 2026.