Normative Assessment of Adaptable Mouthguards.

NCT04056559 | Completed

• 1 other identifier: CHU Bx 2011/04
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Oral Manifestations

Keywords

Prototype; Adaptable mouthguards

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (1)

SIngle arm

EXPERIMENTAL

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

Device: Adaptable mouthguards

Interventions

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).

SIngle arm

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

MeSH Terms

Conditions

Oral Manifestations

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Philippe POISSON, Dr

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 14, 2019
• Study Start: September 9, 2011
• Primary Completion: June 29, 2012
• Study Completion: June 29, 2012
• Last Updated: August 14, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share