Skip to main content
OpenTrials
Completed

NCT Number: NCT04056559

Normative Assessment of Adaptable Mouthguards.

The aim of this study is to the validate adaptable mouthguards prototypes, patented by Bordeaux University and Bordeaux University Hospital.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Oral Manifestations Mouth Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux - Pôle Médecine et chirurgie bucco-dentaire

Bordeaux, 33000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject aged 18 to 35,
  • Subject affiliated to a social security,
  • Subject who has signed the free and informed consent form.

Exclusion criteria

  • 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.

Treatment and study plan

Adaptable mouthguards

Device

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).

Primary outcomes

  1. 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

  2. Impact on O2 consumption

    Time frame: At Week 51

    Average of measured values in one minute, compared to reference of the subject

  3. Impact on respiratory rate

    Time frame: At Week 51

    Average of measured values in one minute, compared to reference of the subject

  4. Impact on current volume

    Time frame: At Week 51

    Average of measured values in one minute, compared to reference of the subject

  5. Impact on CO2 production

    Time frame: At Week 51

    Average of measured values in one minute, compared to reference of the subject

  6. 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)

  7. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: ENORMPIBA

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 14, 2019
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.