Mandibular Stability and Dentofacial Deformity

Tracking Information
First Submitted Date	December 2, 2011
First Posted Date	December 6, 2011
Last Update Posted Date	June 14, 2013
Study Start Date	July 2012
Actual Primary Completion Date	February 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: June 12, 2013)	Variability in mandibular position for different dental occlusion registrations [ Time Frame: Perioperative to orthognathic surgery ]; Centric occlusion, maximum intercuspation and occlusion under general anesthesia
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT01486069 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Mandibular Stability and Dentofacial Deformity
Official Title	Evaluation of the Perioperative Mandibular Positional Stability in Subjects With Dentofacial Deformity
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.
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
Study Design	Observational Model: Case-Only; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
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.
Condition	Maxillofacial Abnormalities
Intervention	Not Provided
Study Groups/Cohorts	Dentofacial Deformity; Patients with dentofacial deformities candidate to orthognathic surgery
Publications *	Bamber MA, Abang Z, Ng WF, Harris M, Linney A. The effect of posture and anesthesia on the occlusal relationship in orthognathic surgery. J Oral Maxillofac Surg. 1999 Oct;57(10):1164-72; discussion 1172-4.; Posnick JC, Ricalde P, Ng P. A modified approach to "model planning" in orthognathic surgery for patients without a reliable centric relation. J Oral Maxillofac Surg. 2006 Feb;64(2):347-56.; Turvey T. Sequencing of two-jaw surgery: the case for operating on the maxilla first. J Oral Maxillofac Surg. 2011 Aug;69(8):2225. doi: 10.1016/j.joms.2010.10.050. Epub 2011 Feb 3.; Perez D, Ellis E 3rd. Sequencing bimaxillary surgery: mandible first. J Oral Maxillofac Surg. 2011 Aug;69(8):2217-24. doi: 10.1016/j.joms.2010.10.053. Epub 2011 Feb 3.; Weffort SY, de Fantini SM. Condylar displacement between centric relation and maximum intercuspation in symptomatic and asymptomatic individuals. Angle Orthod. 2010 Sep;80(5):835-42. doi: 10.2319/090909-510.1.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: December 5, 2011)	30
Original Estimated Enrollment	Same as current
Actual Study Completion Date	June 2013
Actual Primary Completion Date	February 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Older Adult
Accepts Healthy Volunteers	Yes
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Brazil
Removed Location Countries
Administrative Information
NCT Number	NCT01486069
Other Study ID Numbers	FOUSP - PhD Surg - 01
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Alexandre Meireles Borba, University of Sao Paulo
Study Sponsor	University of Sao Paulo
Collaborators	Not Provided
Investigators	Principal Investigator: Alexandre M Borba, DDS, MSc University of Sao Paulo
PRS Account	University of Sao Paulo
Verification Date	June 2013