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Influence of Dental Occlusion on the Performance of High Level Rowers (IODPR) (IODPR)

Primary Purpose

Dental Occlusion, Traumatic

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
with artificial occlusal disturbance
without artificial occlusal disturbance
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Dental Occlusion, Traumatic focused on measuring young elite rowers

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • CREPS de Wattignies

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Rowing training session

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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).

Full Information

First Posted
May 25, 2018
Last Updated
August 23, 2018
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03648125
Brief Title
Influence of Dental Occlusion on the Performance of High Level Rowers (IODPR)
Acronym
IODPR
Official Title
Influence of Dental Occlusion on the Performance of High Level Rowers (IODPR)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why 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
Study Start Date
October 27, 2017 (Actual)
Primary Completion Date
November 22, 2017 (Actual)
Study Completion Date
November 22, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Monocentric, prospective, randomized, open-label, cross-over study.
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Occlusion, Traumatic
Keywords
young elite rowers

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Prospective, monocentric, randomized, open-label, cross-over study. Randomization applies on the order of the training sessions "with" or "without" occlusal disturbance.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rowing training session
Arm Type
Other
Arm Description
Power tests, balance and tonicity tests are performed eyes opened and eyes closed : with artificial occlusal disturbance and without artificial occlusal disturbance
Intervention Type
Device
Intervention Name(s)
with artificial occlusal disturbance
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
without artificial occlusal disturbance
Intervention Description
The training session is performed without occlusal disturbance
Primary Outcome Measure Information:
Title
Muscular power
Description
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.
Time Frame
At the time of inclusion
Secondary Outcome Measure Information:
Title
Surface of the pressure center of the rower's feet
Description
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
Time Frame
At the time of inclusion
Title
Velocity of the pressure center of the rower's feet
Description
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.
Time Frame
At the time of inclusion
Title
Tonicity of the para-vertebral muscles
Description
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).
Time Frame
At the time of inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier MD RAVALEC
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CREPS de Wattignies
City
Wattignies
State/Province
Hauts-de-France
ZIP/Postal Code
59139
Country
France

12. IPD Sharing Statement

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Influence of Dental Occlusion on the Performance of High Level Rowers (IODPR)

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