Study Stopped
Limited time between the beginning and the end of the inclusions, only 7 high level rowers available within the time compatible with research realization
Influence of Dental Occlusion on the Performance of High Level Rowers (IODPR)
IODPR
1 other identifier
interventional
7
1 country
1
Brief Summary
Monocentric, prospective, randomized, open-label, cross-over study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 22, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 22, 2017
CompletedFirst Submitted
Initial submission to the registry
May 25, 2018
CompletedFirst Posted
Study publicly available on registry
August 27, 2018
CompletedAugust 27, 2018
August 1, 2018
26 days
May 25, 2018
August 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Muscular power
Muscular power (in Watts) developed by the high level rowers with the "leg press" test on a "Dyno concept 2" machine, with and without artificial occlusal disturbance. Each test lasts 30 seconds. The sequence consists in 2 tests and is performed twice with a resting period of 1 min between each recording.
At the time of inclusion
Secondary Outcomes (3)
Surface of the pressure center of the rower's feet
At the time of inclusion
Velocity of the pressure center of the rower's feet
At the time of inclusion
Tonicity of the para-vertebral muscles
At the time of inclusion
Study Arms (1)
Rowing training session
OTHERPower tests, balance and tonicity tests are performed eyes opened and eyes closed : * with artificial occlusal disturbance and * without artificial occlusal disturbance
Interventions
A silicon artificial occlusal disturbance is made from a mould of the rowers mouth and placed in the mouth during the training session. With artificial occlusal disturbance : Maximal Intercuspal Occlusion (MIO) with silicone splint increases the vertical dimension of occlusion of 1, 2 and 4 mm.
The training session is performed without occlusal disturbance
Eligibility Criteria
You may qualify if:
- High level rower, part of the Lille Rowing Hope Pole;
- At least 15 years old;
- Training at the Centre de Ressources, d'Expertise et de Performance Sportive (CREPS) de Wattignies during the period from 01/09/2017 to 31/10/2017;
- Having at least 28 natural or prosthetic teeth in occlusion;
- Not having consumed alcohol in the last 24 hours before the recordings;
- whose parents have given free, informed and written consent for minors;
- Having given free and informed consent, in writing supplemented by the consent of at least one holder of parental authority, if he is a minor;
- Affiliated, himself or through his parents if he is a minor, to a social security scheme.
You may not qualify if:
- Current antecedent(s) or pathology(s) likely to disturb the balance: neurological, ear nose and throat, ophthalmological, orthopedic;
- Temporomandibular joint disorder (s) (pain and / or noise);
- Orofacial symptoms (headache, tinnitus, facial myalgia, bruxism);
- Dental and / or periodontal care in progress;
- Chronic pain requiring daily use of analgesics for more than three months;
- Pregnant or lactating woman;
- Concurrent participation in another study;
- Major persons subject to legal protection (safeguard of justice, guardianship, tutorship) and persons deprived of their liberty.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CREPS de Wattignies
Wattignies, Hauts-de-France, 59139, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xavier MD RAVALEC
Rennes University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2018
First Posted
August 27, 2018
Study Start
October 27, 2017
Primary Completion
November 22, 2017
Study Completion
November 22, 2017
Last Updated
August 27, 2018
Record last verified: 2018-08