Mandibular Stability and Dentofacial Deformity

Maxillofacial Abnormalities Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01486069
• Other study ID #: FOUSP - PhD Surg - 01
• Status: Completed
• Phase: N/A
• First received: December 2, 2011
• Last updated: June 12, 2013
• Start date: July 2012
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee (Plataforma Brasil- Ministério da Saúde)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dentofacial Deformities
• Maxillofacial Abnormalities

Locations

Country	Name	City	State
Brazil	Hospital Geral Universitario	Cuiaba	Mato Grosso

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variability in mandibular position for different dental occlusion registrations	Centric occlusion, maximum intercuspation and occlusion under general anesthesia	Perioperative to orthognathic surgery	Yes