Dental Occlusion, TraumaticIODPRNCT03648125
Influence of Dental Occlusion on the Performance of High Level Rowers (IODPR)
A study testing with artificial occlusal disturbance and without artificial occlusal disturbance in people with Dental Occlusion, Traumatic, run by Rennes University Hospital at 1 site in France.
Trial summary
Monocentric, prospective, randomized, open-label, cross-over study. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Occlusion, Traumatic
- What is being tested?
- with artificial occlusal disturbance and without artificial occlusal disturbance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 27 Oct 2017to 22 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Monocentric, prospective, randomized, open-label, cross-over study.
Read the 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
- Conditions
- Dental Occlusion, Traumatic
- Being tested
- with artificial occlusal disturbance, without artificial occlusal disturbance
- Keywords
- young elite rowers
- Medical subject headings
- Dental Occlusion, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
with artificial occlusal disturbanceDevice
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 disturbanceDevice
The training session is performed without occlusal disturbance
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: with artificial occlusal disturbance; Device: without artificial occlusal disturbance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of inclusion
Secondary outcomes (3)
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
Measured: At the time of inclusion
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.
Measured: At the time of inclusion
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).
Measured: At the time of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start27 Oct 2017
- Primary completion22 Nov 2017
- Study completion22 Nov 2017
Why it 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Occlusion, TraumaticStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier MD RAVALEC, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648125
- Sponsor's protocol ID
- 35RC17_8823_IODPR
- Acronym
- IODPR
- Status last verified
- Aug 2018
- First submitted
- 25 May 2018
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Dental Occlusion on the Performance of High Level Rowers (IODPR)
- ClinicalTrials.gov ID
- NCT03648125
- Acronym / sponsor ID
- IODPR / 35RC17_8823_IODPR
- Conditions
- Dental Occlusion, Traumatic
- Keywords
- young elite rowers
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 27 Oct 2017 (actual)
- Primary completion
- 22 Nov 2017 (actual)
- Study completion
- 22 Nov 2017 (actual)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, monocentric, randomized, open-label, cross-over study. Randomization applies on the order of the training sessions "with" or "without" occlusal disturbance.
| Arm | Type | Receives |
|---|---|---|
| Rowing training session | Other | Device: with artificial occlusal disturbance, Device: without artificial occlusal disturbancePower tests, balance and tonicity tests are performed eyes opened and eyes closed : * with artificial occlusal disturbance and * without artificial occlusal disturbance |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| with artificial occlusal disturbanceA 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 | Rowing training session |
| without artificial occlusal disturbanceThe training session is performed without occlusal disturbance | Device | Rowing training session |
Primary outcome
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.
3 secondary outcomes
Surface of the pressure center of the rower's feet
Time frame: At the time of inclusion
Velocity of the pressure center of the rower's feet
Time frame: At the time of inclusion
Tonicity of the para-vertebral muscles
Time frame: At the time of inclusion
Results and safety
The study was stopped early (reason given: Limited time between the beginning and the end of the inclusions, only 7 high level rowers available within the time compatible with research realization). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier MD RAVALEC principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing with artificial occlusal disturbance and without artificial occlusal disturbance in people with Dental Occlusion, Traumatic, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Limited time between the beginning and the end of the inclusions, only 7 high level rowers available within the time compatible with research realization). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscular power (time frame: At the time of inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2018.