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Mandibular Stability and Dentofacial Deformity
This study has been completed.
Sponsor:
University of Sao Paulo
Information provided by (Responsible Party):
Alexandre Meireles Borba, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01486069
First received: December 2, 2011
Last updated: June 12, 2013
Last verified: June 2013
| Tracking Information | ||||
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| First Received Date ICMJE | December 2, 2011 | |||
| Last Updated Date | June 12, 2013 | |||
| Start Date ICMJE | July 2012 | |||
| Primary Completion Date | February 2013 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE |
Variability in mandibular position for different dental occlusion registrations [ Time Frame: Perioperative to orthognathic surgery ] Centric occlusion, maximum intercuspation and occlusion under general anesthesia |
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| Original Primary Outcome Measures ICMJE | Not Provided | |||
| Change History | Complete list of historical versions of study NCT01486069 on ClinicalTrials.gov Archive Site | |||
| Current Secondary Outcome Measures ICMJE | Not Provided | |||
| Original Secondary Outcome Measures ICMJE | Not Provided | |||
| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | Mandibular Stability and Dentofacial Deformity | |||
| Official Title ICMJE | 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 ICMJE | Observational | |||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| 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 ICMJE | Maxillofacial Abnormalities | |||
| Intervention ICMJE | Not Provided | |||
| Study Groups/Cohorts | Dentofacial Deformity
Patients with dentofacial deformities candidate to orthognathic surgery |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 30 | |||
| Completion Date | June 2013 | |||
| Primary Completion Date | February 2013 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Senior | |||
| Accepts Healthy Volunteers | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Brazil | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01486069 | |||
| Other Study ID Numbers ICMJE | 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 ICMJE | University of Sao Paulo | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | University of Sao Paulo | |||
| Verification Date | June 2013 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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