Normative Assessment of Adaptable Mouthguards. (ENORMPIBA)

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

Study Overview

• Status: Completed
• Conditions: Oral Manifestations
• Intervention / Treatment: Device: Adaptable mouthguards

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SIngle arm; The research is based on a population of men and women practicing a sport at risk of oral trauma.	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).

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Philippe POISSON, Dr, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2011
• Primary Completion (Actual): June 29, 2012
• Study Completion (Actual): June 29, 2012

Study Registration Dates

• First Submitted: August 13, 2019
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (Actual): August 14, 2019

Study Record Updates

• Last Update Posted (Actual): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 13, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Prototype; Adaptable mouthguards
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Oral Manifestations
• Other Study ID Numbers: CHU Bx 2011/04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No