NCT01486069

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2011

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

June 14, 2013

Status Verified

June 1, 2013

Enrollment Period

7 months

First QC Date

December 2, 2011

Last Update Submit

June 12, 2013

Conditions

Keywords

Dentofacial DeformityOrthognathic SurgeryMandibleOrthognathic Surgical Procedures

Outcome Measures

Primary Outcomes (1)

  • Variability in mandibular position for different dental occlusion registrations

    Centric occlusion, maximum intercuspation and occlusion under general anesthesia

    Perioperative to orthognathic surgery

Study Arms (1)

Dentofacial Deformity

Patients with dentofacial deformities candidate to orthognathic surgery

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Geral Universitario

Cuiabá, Mato Grosso, 78000-000, Brazil

Location

Related 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. doi: 10.1016/s0278-2391(99)90476-7.

    PMID: 10513861BACKGROUND
  • 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. doi: 10.1016/j.joms.2005.10.022. No abstract available.

    PMID: 16413911BACKGROUND
  • 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. No abstract available.

    PMID: 21295393BACKGROUND
  • 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. No abstract available.

    PMID: 21292376BACKGROUND
  • 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.

    PMID: 20578853BACKGROUND

MeSH Terms

Conditions

Maxillofacial AbnormalitiesDentofacial Deformities

Condition Hierarchy (Ancestors)

Craniofacial AbnormalitiesMusculoskeletal AbnormalitiesMusculoskeletal DiseasesStomatognathic System AbnormalitiesStomatognathic DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Alexandre M Borba, DDS, MSc

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator - PhD Student in Oral and Maxillofacial Surgery

Study Record Dates

First Submitted

December 2, 2011

First Posted

December 6, 2011

Study Start

July 1, 2012

Primary Completion

February 1, 2013

Study Completion

June 1, 2013

Last Updated

June 14, 2013

Record last verified: 2013-06

Locations