Orthognathic SurgeryNCT01989715
Body Posture Assessment Considering Jaws Position Before and After Orthognathic Surgery on Adult Patient.
A study testing analyzing the position of the body, muscle activity in people with Orthognathic Surgery, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Postural balance on both feet, characteristic of the human species, is possible by the tension of muscle of the whole body from toes to head. Body position depends on many inputs such as vision, vestibule, skin receptors, states of muscle tension receptors. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Orthognathic Surgery
- What is being tested?
- analyzing the position of the body, muscle activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to May 2015
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients (18 to 60 years)
- patients waiting for orthognathic surgery
Who cannot join
- Patient prone to vertigo, dizziness, loss of understanding are, accouphènes.
- Patient with acute pain of migraine-type neck pain, back pain, arthritis, tendonitis.
- Patient with oral pain (acute periodontitis, caries, abscesses)
- Patient with orthopedic prosthesis.
- Patient on muscle relaxant treatment, tranquilizer, antidepressant
- Patient over 60 years of age.
Trial locations and contacts
1 site in 1 country.
francois cheynet contact
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hopitaux de Marseille
Marseille, 13356
FRANCOIS CHEYNET, francois.cheynet@ap-hm.fr
francois cheynet
About this study
Postural balance on both feet, characteristic of the human species, is possible by the tension of muscle of the whole body from toes to head.
Body position depends on many inputs such as vision, vestibule, skin receptors, states of muscle tension receptors. Information is integrated in a complex nervous system via the ascending and descending pathways. The information is then analyzed to provide feedback on body position. Any variation of body position, induces a variation of the center of pressure. Impaired body positioncan cause pain (back pain, neck pain) or long-term deformation (including scoliosis or kyphosis).
Read more
Maxillas position, via the activity of masseter and temporal muscles, acts on the muscle chain that controls posture. Incorrect positioning of the jaw in the three directions of space seems to create an asymmetric masticatory muscles activity and thus destabilize the muscle chain responsible for body position. Repositioning maxillas by orthognathic surgery could alter the body posture via changing the activity of the masticatory muscles.
However, nowadays no clear link has been demonstrated between maxillas repositioning and body posture modification.
The purpose of this study is to highlight the link between posture and jaws position, by analyzing the variation of the masticatory muscles activity and, the changes in body center of pressure before and after orthognathic surgery of jaws standardization.
In this study each patient will be evaluated in terms of occlusion and body posture before surgery and after surgery (2 months) by the same protocol. The surgery will be performed in the Maxillofacial Surgery service - Pr BLANC and assessment will take place in the dentistry department - Prof. Salvadori La Timone Hospital, Marseille.
The assessment includes the body posture study with a stabilometric platform (eyes open / eyes closed and with / without tooth contact), and analysis of the head orientation relative to the vertical. Electromyographic muscle masseter assessment (jaw with/without contact ) are devoted to check the evolution of the developed forces, and hand strength will be recorded using a dynamometer.
All these data will be recorded for all the patients. Patients will be divided into four subgroups: (1) maxillary endognathia, (2) mandibular prognathism , (3) mandibular retrognathia and (4 mandible repositioning.
Statistical analysis is aimed at validating or not the hypothesis of changes in body posture caused by surgical maxillas repositioning.
- Conditions
- Orthognathic Surgery
- Being tested
- analyzing the position of the body, muscle activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
analyzing the position of the body, muscle activityOther
| Study group | Role | What they receive |
|---|---|---|
| adult patients waiting for orthognathic surgery | Experimental | Not described Receives: Other: analyzing the position of the body, muscle activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
postural assessment
Analysis before and after orthognathic surgery
Measured: 6 mois
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2014 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthognathic SurgeryStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LOIC MONDOLONI, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989715
- Sponsor's protocol ID
- 2013-A00634-41
- Other IDs
- 2013-15
- Status last verified
- Jul 2014
- First submitted
- 25 Sep 2013
- Last updated
- 24 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Posture Assessment Considering Jaws Position Before and After Orthognathic Surgery on Adult Patient.
- ClinicalTrials.gov ID
- NCT01989715
- Acronym / sponsor ID
- 2013-A00634-41
- Conditions
- Orthognathic Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Nov 2014 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 21 Nov 2013 (estimated)
- 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.
Postural balance on both feet, characteristic of the human species, is possible by the tension of muscle of the whole body from toes to head.
Body position depends on many inputs such as vision, vestibule, skin receptors, states of muscle tension receptors. Information is integrated in a complex nervous system via the ascending and descending pathways. The information is then analyzed to provide feedback on body position. Any variation of body position, induces a variation of the center of pressure. Impaired body positioncan cause pain (back pain, neck pain) or long-term deformation (including scoliosis or kyphosis).
Maxillas position, via the activity of masseter and temporal muscles, acts on the muscle chain that controls posture. Incorrect positioning of the jaw in the three directions of space seems to create an asymmetric masticatory muscles activity and thus destabilize the muscle chain responsible for body position. Repositioning maxillas by orthognathic surgery could alter the body posture via changing the activity of the masticatory muscles.
However, nowadays no clear link has been demonstrated between maxillas repositioning and body posture modification.
The purpose of this study is to highlight the link between posture and jaws position, by analyzing the variation of the masticatory muscles activity and, the changes in body center of pressure before and after orthognathic surgery of jaws standardization.
In this study each patient will be evaluated in terms of occlusion and body posture before surgery and after surgery (2 months) by the same protocol. The surgery will be performed in the Maxillofacial Surgery service - Pr BLANC and assessment will take place in the dentistry department - Prof. Salvadori La Timone Hospital, Marseille.
The assessment includes the body posture study with a stabilometric platform (eyes open / eyes closed and with / without tooth contact), and analysis of the head orientation relative to the vertical. Electromyographic muscle masseter assessment (jaw with/without contact ) are devoted to check the evolution of the developed forces, and hand strength will be recorded using a dynamometer.
All these data will be recorded for all the patients. Patients will be divided into four subgroups: (1) maxillary endognathia, (2) mandibular prognathism , (3) mandibular retrognathia and (4 mandible repositioning.
Statistical analysis is aimed at validating or not the hypothesis of changes in body posture caused by surgical maxillas repositioning.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adult patients waiting for orthognathic surgery | Experimental | Other: analyzing the position of the body, muscle activity |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adult patients (18 to 60 years)
- patients waiting for orthognathic surgery
Key exclusion criteria (6 listed)
- Patient prone to vertigo, dizziness, loss of understanding are, accouphènes.
- Patient with acute pain of migraine-type neck pain, back pain, arthritis, tendonitis.
- Patient with oral pain (acute periodontitis, caries, abscesses)
- Patient with orthopedic prosthesis.
- Patient on muscle relaxant treatment, tranquilizer, antidepressant
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 |
|---|---|---|
| analyzing the position of the body, muscle activity | Other | adult patients waiting for orthognathic surgery |
Primary outcome
postural assessment
Time frame: 6 mois
Analysis before and after orthognathic surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
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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.
francois cheynet contact
LOIC MONDOLONI study director
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing analyzing the position of the body, muscle activity in people with Orthognathic Surgery, run by Assistance Publique Hopitaux De Marseille 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 24 Jul 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact francois cheynet (francois.cheynet@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postural assessment (time frame: 6 mois). 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 24 Jul 2014.