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

• ClinicalTrials.gov Identifier: NCT03648125
• Recruitment Status: Terminated
• First Posted: August 27, 2018
• Last Update Posted: August 27, 2018
• Sponsor: Rennes University Hospital
• Information provided by (Responsible Party): Rennes University Hospital

Tracking Information

• First Submitted Date: May 25, 2018
• First Posted Date: August 27, 2018
• Last Update Posted Date: August 27, 2018
• Actual Study Start Date: October 27, 2017
• Actual Primary Completion Date: November 22, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 23, 2018)

Muscular power [ Time Frame: At the time of inclusion ]

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: August 23, 2018)

• Surface of the pressure center of the rower's feet [ Time Frame: At the time of inclusion ]
  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 [ Time Frame: At the time of inclusion ]
  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 [ Time Frame: At the time of inclusion ]
  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).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Influence of Dental Occlusion on the Performance of High Level Rowers (IODPR)
• Official Title: Influence of Dental Occlusion on the Performance of High Level Rowers (IODPR)
• 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

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention 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)
Primary Purpose: Basic Science

• Condition: Dental Occlusion, Traumatic

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.

• Device: without artificial occlusal disturbance
  The training session is performed without occlusal disturbance

Study Arms

Rowing training session

Power tests, balance and tonicity tests are performed eyes opened and eyes closed :

• with artificial occlusal disturbance and
• without artificial occlusal disturbance

Interventions:

• Device: with artificial occlusal disturbance
• Device: without artificial occlusal disturbance

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: August 23, 2018): 7
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: November 22, 2017
• Actual Primary Completion Date: November 22, 2017 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 15 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT03648125
• Other Study ID Numbers: 35RC17_8823_IODPR
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Rennes University Hospital
• Study Sponsor: Rennes University Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Xavier MD RAVALEC; Rennes University Hospital

• PRS Account: Rennes University Hospital
• Verification Date: August 2018