Mandibular Stability and Dentofacial Deformity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01486069
Recruitment Status : Completed
First Posted : December 6, 2011
Last Update Posted : June 14, 2013
Information provided by (Responsible Party):
Alexandre Meireles Borba, University of Sao Paulo

Brief Summary:
The present study intends to clarify whether there is positional mandibular stability in patients to be submitted to orthognathic surgery. In case of any instability exists, it is needed to understand if this could be related to a particular type of dentofacial deformity or could have any short-term or long-term influence on outcomes of the orthognathic surgery.

Condition or disease
Maxillofacial Abnormalities

Detailed Description:
Treatment of skeletal discrepancy nowadays is mainly performed by combination of clinical and surgical procedures in which orthodontics intends to align the teeth according to their respective alveolar bone and the surgical procedure - orthognathic surgery - realign the jaws in an adequate position among themselves and related to the rest of the craniofacial skeleton. Orthognathic surgery has developed throughout the years technically as well as regarding fixation devices for the operated segments, providing prediction of results with a low complication incidence. A debate point is related to the possible instability of the mandibular position as a reference for surgical planning due to its articulation with the temporal fossa, the temporomandibular joint. However, studies have shown that not always the mandible position obtained for the articulator reflects the position observed in subjects after induction of general anesthesia. Since there is no evidence that indicates that any alteration of the position of the mandible could influence the outcomes of a orthognathic surgery nor any relationship of a certain type of dentofacial deformity that would be beneficiated by an specific order of surgery or skeletal reference (maxilla or mandible), the present study intends to clarify some of these questions.

Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of the Perioperative Mandibular Positional Stability in Subjects With Dentofacial Deformity
Study Start Date : July 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : June 2013

Dentofacial Deformity
Patients with dentofacial deformities candidate to orthognathic surgery

Primary Outcome Measures :
  1. Variability in mandibular position for different dental occlusion registrations [ Time Frame: Perioperative to orthognathic surgery ]
    Centric occlusion, maximum intercuspation and occlusion under general anesthesia

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Data will be obtained from subjects to be submitted to orthognathic surgery by the Department of Oral & Maxillofacial Surgery of the Hospital Geral Universitário of the city of Cuiabá - Brazil during the period of March 2012 through March 2013. Considering the local demand, thirty subjects are expected to be included in the research.

Inclusion Criteria:

  • Dentofacial Deformity candidate to orthognathic surgery;
  • Systemically capable to be submitted to the orthognathic surgery.

Exclusion Criteria:

  • Patient's health condition is not stable enough to guarantee uneventful outcome;
  • Required data unable to be achieved;
  • Patient not agreeing to participate to the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01486069

Hospital Geral Universitario
Cuiaba, Mato Grosso, Brazil, 78000-000
Sponsors and Collaborators
University of Sao Paulo
Principal Investigator: Alexandre M Borba, DDS, MSc University of Sao Paulo

Responsible Party: Alexandre Meireles Borba, Principal Investigator - PhD Student in Oral and Maxillofacial Surgery, University of Sao Paulo Identifier: NCT01486069     History of Changes
Other Study ID Numbers: FOUSP - PhD Surg - 01
First Posted: December 6, 2011    Key Record Dates
Last Update Posted: June 14, 2013
Last Verified: June 2013

Keywords provided by Alexandre Meireles Borba, University of Sao Paulo:
Dentofacial Deformity
Orthognathic Surgery
Orthognathic Surgical Procedures

Additional relevant MeSH terms:
Congenital Abnormalities
Dentofacial Deformities
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Stomatognathic System Abnormalities
Stomatognathic Diseases