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Completed

NCT Number: NCT01486069

Mandibular Stability and Dentofacial Deformity

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Evaluation of the Perioperative Mandibular Positional Stability in Subjects With Dentofacial Deformity

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 6, 2011
Registry last updated
Jun 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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