Normative Assessment of Adaptable Mouthguards.

Oral Manifestations Clinical Trial

— ENORMPIBA  

Official title:

Normative Assessment of Adaptable Mouthguards.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04056559
• Other study ID #: CHU Bx 2011/04
• Status: Completed
• Phase: N/A
• Start date: September 9, 2011
• Est. completion date: June 29, 2012

Study information

• Verified date: August 2019
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 29, 2012
• Est. primary completion date: June 29, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Oral Manifestations

Intervention

Device:
• Adaptable mouthguards
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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At Week 51
Primary	Impact on O2 consumption	Average of measured values in one minute, compared to reference of the subject	At Week 51
Primary	Impact on respiratory rate	Average of measured values in one minute, compared to reference of the subject	At Week 51
Primary	Impact on current volume	Average of measured values in one minute, compared to reference of the subject	At Week 51
Primary	Impact on CO2 production	Average of measured values in one minute, compared to reference of the subject	At Week 51
Primary	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)	At Week 51
Primary	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.	At Week 52