Maxillofacial AbnormalitiesNCT01486069
Mandibular Stability and Dentofacial Deformity
An observational study of Maxillofacial Abnormalities, run by University of Sao Paulo at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Maxillofacial Abnormalities
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2012to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Dentofacial Deformity candidate to orthognathic surgery;
- Systemically capable to be submitted to the orthognathic surgery.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Perioperative Mandibular Positional Stability in Subjects With 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.
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.
- Conditions
- Maxillofacial Abnormalities
- Keywords
- Dentofacial Deformity, Orthognathic Surgery, Mandible, Orthognathic Surgical Procedures
- Medical subject headings
- Maxillofacial Abnormalities, Dentofacial Deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dentofacial Deformity | Patients with dentofacial deformities candidate to orthognathic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variability in mandibular position for different dental occlusion registrations
Centric occlusion, maximum intercuspation and occlusion under general anesthesia
Measured: Perioperative to orthognathic surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2011 (estimated)
- Study startJul 2012
- Primary completionFeb 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Maxillofacial AbnormalitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandre Meireles Borba, University of Sao Paulo
- Investigators
- Alexandre M Borba, DDS, MSc, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01486069
- Sponsor's protocol ID
- FOUSP - PhD Surg - 01
- Status last verified
- Jun 2013
- First submitted
- 2 Dec 2011
- Last updated
- 14 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
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 10513861Posnick 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 16413911Turvey 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 21295393Perez 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 21292376Weffort 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Perioperative Mandibular Positional Stability in Subjects With Dentofacial Deformity
- ClinicalTrials.gov ID
- NCT01486069
- Acronym / sponsor ID
- FOUSP - PhD Surg - 01
- Conditions
- Maxillofacial Abnormalities
- Keywords
- Dentofacial Deformity, Orthognathic Surgery, Mandible, Orthognathic Surgical Procedures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 6 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dentofacial Deformity | – | –Patients with dentofacial deformities candidate to orthognathic surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Dentofacial Deformity candidate to orthognathic surgery;
- Systemically capable to be submitted to the orthognathic surgery.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Variability in mandibular position for different dental occlusion registrations
Time frame: Perioperative to orthognathic surgery
Centric occlusion, maximum intercuspation and occlusion under general anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2013.
- Background: PubMed 10513861Bamber 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.
- Background: PubMed 16413911Posnick 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.
- Background: PubMed 21295393Turvey 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.
- Background: PubMed 21292376Perez 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.
- Background: PubMed 20578853Weffort 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.
Related trials for Maxillofacial Abnormalities
RecruitingObservational study
Natural History of Craniofacial Anomalies and Developmental Growth Variants
Prognathism, Retrognathism
Not yet recruiting
Furlow With Buccinator and Fistula Formation
Cleft Palate
Recruiting
Comparing 3D-Printed and Milled Titanium Plates in Jaw Surgery (Le Fort I): Accuracy and Operative Time
Malocclusion, Angle Class II, Malocclusion, Angle Class III
RecruitingPhase 3
Nebulized Bupivacaine Analgesia for Cleft Palate Repair
Cleft Palate
Recruiting
Quantitative Evaluation of Attention to Faces After Orthognathic Surgery With Eye-tracking
Dentofacial Deformities, Orthognathic Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre M Borba, DDS, MSc principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maxillofacial Abnormalities, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variability in mandibular position for different dental occlusion registrations (time frame: Perioperative to orthognathic surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01486069, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2013.