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Normative Assessment of Adaptable Mouthguards. (ENORMPIBA)

Primary Purpose

Oral Manifestations

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Adaptable mouthguards

About this trial

This is an interventional device feasibility trial for Oral Manifestations focused on measuring Prototype, Adaptable mouthguards

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SIngle arm

Arm Description

The research is based on a population of men and women practicing a sport at risk of oral trauma.

Outcomes

Primary Outcome Measures

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

Impact on O2 consumption

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

Impact on respiratory rate

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

Impact on current volume

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

Impact on CO2 production

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

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)

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04056559

First Posted

August 13, 2019

Last Updated

August 13, 2019

Sponsor

University Hospital, Bordeaux

1. Study Identification

Unique Protocol Identification Number

NCT04056559

Brief Title

Normative Assessment of Adaptable Mouthguards.

Acronym

ENORMPIBA

Official Title

Normative Assessment of Adaptable Mouthguards.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

September 9, 2011 (Actual)

Primary Completion Date

June 29, 2012 (Actual)

Study Completion Date

June 29, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oral Manifestations

Keywords

Prototype, Adaptable mouthguards

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SIngle arm

Arm Type

Experimental

Arm Description

The research is based on a population of men and women practicing a sport at risk of oral trauma.

Intervention Type

Device

Intervention Name(s)

Adaptable mouthguards

Intervention Description

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 Outcome Measure Information:

Title

Impact on ventilatory flow rate by minute

Description

Average of measured values in one minute, compared to maximum aerobic reference speed of the subject Modification of the ventilatory flow rate by min

Time Frame

At Week 51

Title

Impact on O2 consumption

Description

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

Time Frame

At Week 51

Title

Impact on respiratory rate

Description

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

Time Frame

At Week 51

Title

Impact on current volume

Description

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

Time Frame

At Week 51

Title

Impact on CO2 production

Description

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

Time Frame

At Week 51

Title

Impact on comfort according an analogical visual scale for 11 criteria

Description

Time Frame

At Week 51

Title

Impact on electromyographic recording

Description

Time Frame

At Week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philippe POISSON, Dr

Organizational Affiliation

University Hospital, Bordeaux

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Normative Assessment of Adaptable Mouthguards.

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