- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01989715
Body Posture Assessment Considering Jaws Position Before and After Orthognathic Surgery on Adult Patient.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Marseille, France, 13356
- Recruiting
- Assistance Publique Hopitaux de Marseille
-
Contact:
- FRANCOIS CHEYNET
- Email: francois.cheynet@ap-hm.fr
-
Principal Investigator:
- francois cheynet
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult patients (18 to 60 years)
- patients waiting for orthognathic surgery
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: adult patients waiting for orthognathic surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postural assessment
Time Frame: 6 mois
|
Analysis before and after orthognathic surgery
|
6 mois
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2013-A00634-41
- 2013-15 (OTHER: AP HM)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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