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CompletedNCT01486069Updated Jun 14, 2013

Mandibular Stability and Dentofacial Deformity

An observational study in Maxillofacial Abnormalities, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Per ClinicalTrials.gov, last updated 2013-06-14.

Primary conditionDentofacial DeformitiesRegistry: Maxillofacial AbnormalitiesReclassifiedWhy we changed it
Registry
Maxillofacial Abnormalities — the first condition term the registry derived for this study.
ClinicalTrials.gg
Dentofacial Deformities
Why
  1. The study's title name Dentofacial Deformities, a narrower term within Maxillofacial Abnormalities.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Sao Paulo · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
30
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Maxillofacial Abnormalities

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Keywords

  • Dentofacial Deformity
  • Orthognathic Surgery
  • Mandible
  • Orthognathic Surgical Procedures
03

In context

Dentofacial Deformities Reclassified

40 studies on the registry are indexed under Dentofacial Deformities; 16 are open to participants now.

This study's enrollment of 30 is below the median of 45 across 15 observational studies indexed under Dentofacial Deformities.

Browse Dentofacial Deformities studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,035 studies on the registry; 95 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Compared within Dentofacial Deformities, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Maxillofacial Abnormalities. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
30 participants (actual)

Groups and cohorts

  • Dentofacial Deformity

    Patients with dentofacial deformities candidate to orthognathic surgery

06

What researchers measure

Primary outcomes

  1. Variability in mandibular position for different dental occlusion registrations

    Centric occlusion, maximum intercuspation and occlusion under general anesthesia

    Time frame: Perioperative to orthognathic surgery

07

Study locations

1 site
  • Hospital Geral Universitario
    Cuiaba, Mato Grosso 78000-000, Brazil
08

References and documents

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. doi: 10.1016/s0278-2391(99)90476-7. PubMed 10513861 ↗
  • 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. PubMed 16413911 ↗
  • 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. PubMed 21295393 ↗
  • 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. PubMed 21292376 ↗
  • 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. PubMed 20578853 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2012, a primary completion of Feb 2013 and a completion of Jun 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 2, 2011
First posted
Dec 6, 2011
Start
Jul 2012
Primary completionActual
Feb 2013
CompletionActual
Jun 2013
Last update
Jun 14, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 14, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01486069
Responsible party
Alexandre Meireles Borba (Principal Investigator - PhD Student in Oral and Maxillofacial Surgery, University of Sao Paulo) — Principal investigator
First posted
Dec 6, 2011
Start date
Jul 2012
Primary completion
Feb 2013
Completion
Jun 2013
Last update
Jun 14, 2013

Study contacts

Alexandre M Borba, DDS, MSc
principal investigator · University of Sao Paulo

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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