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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03648125
Other study ID # 35RC17_8823_IODPR
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date October 27, 2017
Est. completion date November 22, 2017

Study information

Verified date August 2018
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

Current literature data suggest that dental occlusion has an influence on postural control in the general population, and more markedly in high-level athletes. The link between dental occlusion and the postural stability of top athletes has been studied in several disciplines such as basketball, shooting, golf and running. There is currently no data in the field of rowing. But this sport requires optimal postural control for synchronous and symmetrical muscle solicitation.

The present study aims to evaluate the influence of dental occlusion on postural stability and the performance of high level rowers.

Our assumptions are as follows:

- Occlusal disturbance alters the muscular power developed by high level rowers

- occlusal disturbance alters the static postural stability of high level rowers


Recruitment information / eligibility

Status Terminated
Enrollment 7
Est. completion date November 22, 2017
Est. primary completion date November 22, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
with artificial occlusal disturbance
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.
without artificial occlusal disturbance
The training session is performed without occlusal disturbance

Locations

Country Name City State
France CREPS de Wattignies Wattignies Hauts-de-France

Sponsors (1)

Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Surface of the pressure center of the rower's feet Each test lasts 51.2 seconds. The sequence consists in 10 tests and is performed twice with a resting period of 1 min between each recording.
During each test, the projected sway area (in mm², the area of the confidence ellipse containing 90% of the sampled positions of the foot pressure center on the statokinesigram) is extracted from the stabilometric platform
At the time of inclusion
Secondary Velocity of the pressure center of the rower's feet Each test lasts 51.2 seconds. The sequence consists in 10 tests and is performed twice with a resting period of 1 min between each recording.
During each test, the sway velocity (in mm/s) is calculated as the speed of displacement of the center of pressure of the foot as a function of the average position on the antero-posterior axis of the statokinesigram.
At the time of inclusion
Secondary Tonicity of the para-vertebral muscles Tonicity of the para-vertebral muscles is evaluated with the postural test of Posterior-superior iliac spines (PSIS) with and without artificial occlusal disturbance. This PSIS test is performed eyes opened, in MIO position with and without artificial occlusal disturbance,
The sequence of two tests is performed twice. During this test, the endpoint is qualitative: operator asymmetric thumbs' ascension reflecting asymmetric contraction of paravertebral muscles (abnormal response) or not (normal response).
At the time of inclusion
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