NCT01989715

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 21, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

July 24, 2014

Status Verified

July 1, 2014

Enrollment Period

1.1 years

First QC Date

September 25, 2013

Last Update Submit

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

EXPERIMENTAL
Other: analyzing the position of the body, muscle activity

Interventions

adult patients waiting for orthognathic surgery

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

RECRUITING

Study Officials

  • LOIC MONDOLONI

    Assistance Publique Hopitaux De Marseille

    STUDY DIRECTOR

Central Study Contacts

francois cheynet

CONTACT

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

Locations