NCT02529020

Brief Summary

The latest findings on the ergogenic effects of a dentistry-design, bite-aligning mouthpiece require additional research to assess its impact on anaerobic ability and ventilatory parameters. This study was aimed at determining the ergogenic acute effects of wearing a custom-made mouthpiece on oral airflow dynamics, Wingate Test performance parameters.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
Last Updated

August 13, 2020

Status Verified

August 1, 2020

Enrollment Period

1.2 years

First QC Date

August 11, 2015

Last Update Submit

August 11, 2020

Conditions

Mouth Breathing

Keywords

mouthguardventilationanaerobic powerergogenic effects

Outcome Measures

Primary Outcomes (2)

  • Changes in performance in Wingate test

    Anaerobic power and capacity are assessed using the Wingate test with and without mouthguard (MOUTHG and NO-MOUTHG, respectively). Subjects complete a 30-sec maximal effort on an ergometer at a resistance equivalent to 7.5% of their body mass. The ergometer is interfaced with a computer loaded with software (Wingate Software Version 1.11, Lode BV) that apply the appropriate load for each subject. As a warm-up procedure, subjects are instructed to begin pedaling for 5 minutes at 100 W and approximately 60 rpm. After a 5 second count down and without altering the mentioned parameters, subjects are asked to begin pedaling as fast as possible while receiving verbal encouragement throughout the test. Peak power (W) and mean power (W) are calculated and recorded in an online data acquisition system.

    3 trials spaced 48 hours (each trial 30 seconds)

  • Changes in performance dynamics airflow measurements.

    Subjects are asked to breath at resting pace during 30-sec under three different conditions: open mouth without mouthguard, jaw clenching without mouthguard and jaw clenched with mouthguard (OMNM, JCNM and JCM, respectively). Subjects intercalate 30 second forced breathings under the same conditions. Rest time was 3 minutes after both measurements under each condition. Conditions are randomly distributed. Facemask and is connected to a Biopac MP100 system through the wide-range airflow transducer amplifier. Peak air flow is detected and mean air flow during the 30 second interval is calculated for all conditions in L•min-1.

    3 trials spaced 3 minutes (each trial 30 seconds)

Study Arms (2)

Mouthguard

EXPERIMENTAL

All subjects perform all tests wearing mouthguard.

Device: Mouthguard

No mouthguard

EXPERIMENTAL

All subjects perform all tests without mouthguard

Device: No mouthguard

Interventions

MouthguardDEVICE

Condition of wearing mouthguard

Mouthguard
No mouthguardDEVICE

Condition without mouthguard

No mouthguard

Eligibility Criteria

Age19 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy physical active males

You may not qualify if:

  • Acute or chronic injury that caused pain during testing procedures
  • Temporomandibular joint disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Arent, S. M., McKenna, J.and Golem, D. L. (2010). Effects of a neuromuscular dentistry-designed mouthguard on muscular endurance and anaerobic power. Comparative Exercise Physiology, 7(02), 73-79.

    BACKGROUND

  • Bailey SP, Willauer TJ, Balilionis G, Wilson LE, Salley JT, Bailey EK, Strickland TL. Effects of an over-the-counter vented mouthguard on cardiorespiratory responses to exercise and physical agility. J Strength Cond Res. 2015 Mar;29(3):678-84. doi: 10.1519/JSC.0000000000000668.

    PMID: 25264671BACKGROUND

  • Cetin C, Kececi AD, Erdogan A, Baydar ML. Influence of custom-made mouth guards on strength, speed and anaerobic performance of taekwondo athletes. Dent Traumatol. 2009 Jun;25(3):272-6. doi: 10.1111/j.1600-9657.2009.00780.x.

    PMID: 19583574BACKGROUND

MeSH Terms

Conditions

Mouth BreathingRespiratory Aspiration

Interventions

Mouth Protectors

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

Preventive DentistryDentistryProtective DevicesEquipment and SuppliesPersonal Protective EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Xavier Pujades, PHD

    Vicedagà Facultat ciències de l'Esport Blanquerna

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD

Study Record Dates

First Submitted

August 11, 2015

First Posted

August 19, 2015

Study Start

May 1, 2014

Primary Completion

July 1, 2015

Study Completion

August 1, 2015

Last Updated

August 13, 2020

Record last verified: 2020-08