NCT03648125

Brief Summary

Monocentric, prospective, randomized, open-label, cross-over study.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

October 27, 2017

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 27, 2018

Completed
Last Updated

August 27, 2018

Status Verified

August 1, 2018

Enrollment Period

26 days

First QC Date

May 25, 2018

Last Update Submit

August 23, 2018

Conditions

Keywords

young elite rowers

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

OTHER

Power tests, balance and tonicity tests are performed eyes opened and eyes closed : * with artificial occlusal disturbance and * without artificial occlusal disturbance

Device: with artificial occlusal disturbanceDevice: 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.

Rowing training session

The training session is performed without occlusal disturbance

Rowing training session

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Dental Occlusion, Traumatic

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

Study Officials

  • Xavier MD RAVALEC

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Model Details: Prospective, monocentric, randomized, open-label, cross-over study. Randomization applies on the order of the training sessions "with" or "without" occlusal disturbance.
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

Locations