Orthognathic SurgeryPOMOCOBSNCT03357211
Accuracy of Maxillary Repositioning During Orthognathic Surgery
An observational study of Orthognathic Surgery and Maxillofacial Abnormalities, run by Centre Hospitalier Annecy Genevois.
Trial summary
Orthognathic surgery aims to correct jaw position taking into account esthetic and functional criteria (dental occlusion, lip position, breathing...). These surgeries are planned using clinical, radiological and dental cast data. The result of this planning are occlusal splints. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Orthognathic Surgery, Maxillofacial Abnormalities
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 29 Feb 2016to 1 Jun 2017
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients needing orthognathic surgery with monobloc mobilization of the maxilla via a Le Fort I osteotomy alone or associated to a mandibular osteotomy, whatever the indication (malocclusion, sleep apnea, temporomandibular dysfunction...), who are adressed to the principal investigator
Who may be able to join
- patients needing orthognathic surgery with mobilization of the maxilla via a Le Fort I osteotomy, alone or associated to a mandibular osteotomy, whatever the indication (poor occlusion, sleep apnea, temporo-mandibular dysfunction...)
- patient over 16 years old
- having not expressed any opposition to the collection of his/her personal data for this study (patient him/herself or holder of parental authority in case of patients younger than 18)
Who cannot join
- pregnancy
- patients deprived of liberty
- protected adult
- patients needing maxillary disjunction
About this study
Official title: Accuracy of Maxillary Repositioning During Orthognathic Surgery: a Prospective Observational Descriptive Study in Annecy Genevois Hospital
Orthognathic surgery aims to correct jaw position taking into account esthetic and functional criteria (dental occlusion, lip position, breathing...). These surgeries are planned using clinical, radiological and dental cast data. The result of this planning are occlusal splints. Orthognathic surgery had improved in the last decade with 3 dimensions computerized tomography scan (3D CT-Scan) planning and osteosynthesis implants. However the accuracy of the operative results compared to the planned ones has rarely been measured.
Read the detailed description
Orthognathic surgery aims to correct jaw position taking into account esthetic and functional criteria (dental occlusion, lip position, breathing...). These surgeries are planned only after the end of the growing period and in association with orthodontics. It is necessary to wait the end of facial growth to expect a stable result especially concerning mandibular. The age limit seems to be around 15 to 16 years old for retromandibular deformities and around 18 years old for premandibular deformities.
These surgeries are planned using clinical, radiological and dental cast data. Occlusal splints are made using all these results; these occlusal splints are used during the orthognathic surgery to maintain bones in the planned position.
Since 1993, a navigation system (Orthopilot™) is used, which allow to track jaw position, in real time, with an accuracy around one millimeter and one degree, during orthognathic surgery. This system is routinely used for condyle repositioning after mandibular sagittal split osteotomies; but it is also useful for maxillary navigation and positioning.
The investigator propose to measure the accuracy of the operative results compared to the planned ones, using the Orthopilot™ system.
- Conditions
- Orthognathic Surgery, Maxillofacial Abnormalities
- Medical subject headings
- Maxillofacial Abnormalities
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of the translational and rotational shifts of the maxilla between planning and realization
Shifts will be quantified by 6 components (3 in rotation and 3 in translation) in a coordinate system given by Orthopilot™ navigation system.
Accuracy of the surgical technic is evaluated by the distribution of the translational and rotational shifts of the maxilla between planning and realization, taking account conformity (when left/right translation is ≤ 1 mm, top/bottom and back/front translations are < 2 mm, frontal rotation is ≤ 1° and axial and sagittal rotations are ≤ 2°), failure (when left/right, top/bottom and back/front translations are > 2 mm, frontal, axial and sagittal rotations are >4°), and non conformity (every other shifts).
Measured: during the surgery
Secondary outcomes (1)
Inter-incisal vector
The inter-incisal vector (that is square root of the sum of each translation shift squared) is calculated by the statistician. It derived from shifts in millimeter and degree measured during surgery by Orthopilot™ navigation system.
Measured: during the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start29 Feb 2016
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthognathic SurgeryStudies 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
- Centre Hospitalier Annecy Genevois
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georges Bettega, MD/PhD, Principal investigator, CH Annecy Genevois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357211
- Sponsor's protocol ID
- 2016-01-POMOCOBS
- Acronym
- POMOCOBS
- Status last verified
- Nov 2017
- First submitted
- 24 Nov 2017
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Maxillary Repositioning During Orthognathic Surgery: a Prospective Observational Descriptive Study in Annecy Genevois Hospital
- ClinicalTrials.gov ID
- NCT03357211
- Acronym / sponsor ID
- POMOCOBS / 2016-01-POMOCOBS
- Conditions
- Orthognathic Surgery, Maxillofacial Abnormalities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Annecy GenevoisUniversity, hospital or other
- Study start
- 29 Feb 2016 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 29 Nov 2017 (actual)
- 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.
Orthognathic surgery aims to correct jaw position taking into account esthetic and functional criteria (dental occlusion, lip position, breathing...). These surgeries are planned using clinical, radiological and dental cast data. The result of this planning are occlusal splints. Orthognathic surgery had improved in the last decade with 3 dimensions computerized tomography scan (3D CT-Scan) planning and osteosynthesis implants. However the accuracy of the operative results compared to the planned ones has rarely been measured.
Detailed description
Orthognathic surgery aims to correct jaw position taking into account esthetic and functional criteria (dental occlusion, lip position, breathing...). These surgeries are planned only after the end of the growing period and in association with orthodontics. It is necessary to wait the end of facial growth to expect a stable result especially concerning mandibular. The age limit seems to be around 15 to 16 years old for retromandibular deformities and around 18 years old for premandibular deformities.
These surgeries are planned using clinical, radiological and dental cast data. Occlusal splints are made using all these results; these occlusal splints are used during the orthognathic surgery to maintain bones in the planned position.
Since 1993, a navigation system (Orthopilot™) is used, which allow to track jaw position, in real time, with an accuracy around one millimeter and one degree, during orthognathic surgery. This system is routinely used for condyle repositioning after mandibular sagittal split osteotomies; but it is also useful for maxillary navigation and positioning.
The investigator propose to measure the accuracy of the operative results compared to the planned ones, using the Orthopilot™ system.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients needing orthognathic surgery with monobloc mobilization of the maxilla via a Le Fort I osteotomy alone or associated to a mandibular osteotomy, whatever the indication (malocclusion, sleep apnea, temporomandibular dysfunction...), who are adressed to the principal investigator
Key inclusion criteria (3 listed)
- patients needing orthognathic surgery with mobilization of the maxilla via a Le Fort I osteotomy, alone or associated to a mandibular osteotomy, whatever the indication (poor occlusion, sleep apnea, temporo-mandibular dysfunction...)
- patient over 16 years old
- having not expressed any opposition to the collection of his/her personal data for this study (patient him/herself or holder of parental authority in case of patients younger than 18)
Key exclusion criteria (4 listed)
- pregnancy
- patients deprived of liberty
- protected adult
- patients needing maxillary disjunction
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
Distribution of the translational and rotational shifts of the maxilla between planning and realization
Time frame: during the surgery
Shifts will be quantified by 6 components (3 in rotation and 3 in translation) in a coordinate system given by Orthopilot™ navigation system. Accuracy of the surgical technic is evaluated by the distribution of the translational and rotational shifts of the maxilla between planning and realization, taking account conformity (when left/right translation is ≤ 1 mm, top/bottom and back/front translations are < 2 mm, frontal rotation is ≤ 1° and axial and sagittal rotations are ≤ 2°), failure (when left/right, top/bottom and back/front translations are > 2 mm, frontal, axial and sagittal rotations are >4°), and non conformity (every other shifts).
1 secondary outcome
Inter-incisal vector
Time frame: during the surgery
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 2 Dec 2017.
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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.
Georges Bettega, MD/PhD principal investigator
CH Annecy Genevois
Questions about this trial
What is this clinical trial studying?
An observational study of Orthognathic Surgery and Maxillofacial Abnormalities, run by Centre Hospitalier Annecy Genevois.
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 3 inclusion and 4 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 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Distribution of the translational and rotational shifts of the maxilla between planning and realization (time frame: during the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2017.