Body Posture Assessment Considering Jaws Position Before and After Orthognathic Surgery on Adult Patient.
2 other identifiers
interventional
27
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedFirst Posted
Study publicly available on registry
November 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedJuly 24, 2014
July 1, 2014
1.1 years
September 25, 2013
July 23, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
postural assessment
Analysis before and after orthognathic surgery
6 mois
Study Arms (1)
adult patients waiting for orthognathic surgery
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Adult patients (18 to 60 years)
- patients waiting for orthognathic surgery
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assistance Publique Hopitaux de Marseille
Marseille, 13356, France
Study Officials
- STUDY DIRECTOR
LOIC MONDOLONI
Assistance Publique Hopitaux De Marseille
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2013
First Posted
November 21, 2013
Study Start
October 1, 2013
Primary Completion
November 1, 2014
Study Completion
May 1, 2015
Last Updated
July 24, 2014
Record last verified: 2014-07