NCT04056559|Completed
Normative Assessment of Adaptable Mouthguards.
ENORMPIBA
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ENORMPIBA
Sponsor study identifier
interventional
14
1 country
1
Study Start
September 9, 2011
Actual (reported)Primary Completion
June 29, 2012
Actual (reported)Study Completion
June 29, 2012
Actual (reported)The aim of this study is to the validate adaptable mouthguards prototypes, patented by Bordeaux University and Bordeaux University Hospital.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 29, 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 9, 2011
Actual (reported)June 29, 2012
Actual (reported)June 29, 2012
Actual (reported)August 13, 2019
Actual (reported)August 14, 2019
Actual (reported)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
The research is based on a population of men and women practicing a sport at risk of oral trauma.
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
CHU de Bordeaux - Pôle Médecine et chirurgie bucco-dentaire
Bordeaux, 33000, France
Guerard S, Barou JL, Petit J, Poisson P. Characterization of mouth-formed mouthguards: thermal performance. Dent Mater J. 2014;33(6):799-804. doi: 10.4012/dmj.2014-044. Epub 2014 Oct 11.
Philippe POISSON, Dr
University Hospital, Bordeaux
14 participants (actual enrollment reported by the registry).
First Submitted
August 13, 2019
First Posted
August 14, 2019
Study Start
September 9, 2011
Actual (reported)The Effects of Using Augmented Reality (AR) System to Train Foreign Care Workers.
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
Contact the study team to confirm eligibility.
Primary Completion
June 29, 2012
Actual (reported)Study Completion
June 29, 2012
Actual (reported)Last Updated
June 18, 2026
Record last verified: 2019-08
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Source: ClinicalTrials.gov.
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