Jaw AbnormalitiesMILF-INCT02660216
A Modified Minimally Invasive Approach Towards Le Fort I Osteotomy: a Prospective Study
An observational study of Jaw Abnormalities, run by AZ Sint-Jan AV at 1 site in Belgium.
Trial summary
Nowadays, maxillary Le Fort I osteotomy is a safe and routinely performed procedure. The conventional approach is characterized by a vestibular incision extending from molar-to-molar, associated with a pterygomaxillary disjunction performed with a curved chisel. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Jaw Abnormalities
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2014to Dec 2019
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: All consenting patients requiring a bimaxillary orthognathic procedure as part of their orthodontic-surgical treatment plan, and satisfying the inclusion and exclusion criteria.
Who may be able to join
- Patients of all ages
- Patients of all genders
- A Le Fort I osteotomy is planned, as part of a bimaxillary orthognathic procedure
- The surgery is planned with 3D Virtual Treatment Planning (Maxilim v. 2.3.0.3.0.)
- The planning is transferred with 3D CAD/CAM tooth-borne splint and vertical internal bony reference landmarks
- The maxilla is repositioned first during the surgery (maxilla first sequence)
Who cannot join
- Patients not eligible according to abovementioned criteria
- Simultaneous extraction of impacted teeth 18 and/or 28
- Previous maxillary orthognathic surgery
- Previous Surgical Assisted Rapid Palatal Expansion (SARPE)
- Syndromic condition, including cleft lip and palate
- Segmental Le Fort I osteotomy
Show all 9Show fewer
- Adjuvant Zygomatic osteotomy
- Maxillary impaction higher than 3 mm
- Maxillary advancement greater than 5 mm
Trial locations and contacts
1 site in 1 country.
About this study
Nowadays, maxillary Le Fort I osteotomy is a safe and routinely performed procedure. The conventional approach is characterized by a vestibular incision extending from molar-to-molar, associated with a pterygomaxillary disjunction performed with a curved chisel. Adequate mobilization of the maxilla during Le Fort I osteotomy requires an effective separation of the maxillary tuberosity from the pterygoid plates of the sphenoid bone. However, as initially described by Precious (1991) and later by Hernandez-Alfaro (2013), a true pterygomaxillary osteotomy is not necessary to achieve successful disjunction. Furthermore, Hernandez-Alfaro combined his technique of pterygomaxillary disjunction, the so-called "Twist technique", to a minimally invasive protocol, performing the complete Le Fort I osteotomy through a 20 to 30 mm long horizontal vestibular incision. Although promising, the technique remains highly sensitive from a technical standpoint, and its true accuracy has not been comprehensively evaluated.
The purpose of this study is to present and validate a minimally invasive approach towards Le Fort I osteotomy, using a modified pterygomaxillary (PTM) disjunction technique. The primary outcome is to evaluate the accuracy of the technique using rigid voxel-based registration of the 3D virtual treatment planning and the 4 weeks postoperative CBCT images. Secondary outcomes include the surgical time necessary to complete the procedure and the presence of intraoperative and early postoperative complications.
- Conditions
- Jaw Abnormalities
- Keywords
- minimally invasive, le fort I osteotomy, 3D virtual treatment planning, accuracy
- Medical subject headings
- Jaw Abnormalities
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of the minimally invasive approach in comparison to conventional approaches, based on 3D virtual CBCT superimposition of planning CBCT and postoperative CBCT
Measured: at 4 weeks postoperative
Secondary outcomes (2)
Surgical time necessary to complete the procedure
Measured: perioperative
Intraoperative and early postoperative complications
Measured: within 4 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study startNov 2014
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jaw 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gwen Swennen, AZ Sint-Jan AV
- Investigators
- Gwen Swennen, Principal investigator, Division of Maxillofacial Surgery, Department of Surgery, General Hospital Saint-John Bruges, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660216
- Sponsor's protocol ID
- BO49201525495
- Acronym
- MILF-I
- Status last verified
- Jan 2021
- First submitted
- 11 Jan 2016
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Modified Minimally Invasive Approach Towards Le Fort I Osteotomy: a Prospective Study
- ClinicalTrials.gov ID
- NCT02660216
- Acronym / sponsor ID
- MILF-I / BO49201525495
- Conditions
- Jaw Abnormalities
- Keywords
- minimally invasive, le fort I osteotomy, 3D virtual treatment planning, accuracy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 21 Jan 2016 (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.
Nowadays, maxillary Le Fort I osteotomy is a safe and routinely performed procedure. The conventional approach is characterized by a vestibular incision extending from molar-to-molar, associated with a pterygomaxillary disjunction performed with a curved chisel. Adequate mobilization of the maxilla during Le Fort I osteotomy requires an effective separation of the maxillary tuberosity from the pterygoid plates of the sphenoid bone. However, as initially described by Precious (1991) and later by Hernandez-Alfaro (2013), a true pterygomaxillary osteotomy is not necessary to achieve successful disjunction. Furthermore, Hernandez-Alfaro combined his technique of pterygomaxillary disjunction, the so-called "Twist technique", to a minimally invasive protocol, performing the complete Le Fort I osteotomy through a 20 to 30 mm long horizontal vestibular incision. Although promising, the technique remains highly sensitive from a technical standpoint, and its true accuracy has not been comprehensively evaluated.
The purpose of this study is to present and validate a minimally invasive approach towards Le Fort I osteotomy, using a modified pterygomaxillary (PTM) disjunction technique. The primary outcome is to evaluate the accuracy of the technique using rigid voxel-based registration of the 3D virtual treatment planning and the 4 weeks postoperative CBCT images. Secondary outcomes include the surgical time necessary to complete the procedure and the presence of intraoperative and early postoperative complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consenting patients requiring a bimaxillary orthognathic procedure as part of their orthodontic-surgical treatment plan, and satisfying the inclusion and exclusion criteria.
Key inclusion criteria (6 listed)
- Patients of all ages
- Patients of all genders
- A Le Fort I osteotomy is planned, as part of a bimaxillary orthognathic procedure
- The surgery is planned with 3D Virtual Treatment Planning (Maxilim v. 2.3.0.3.0.)
- The planning is transferred with 3D CAD/CAM tooth-borne splint and vertical internal bony reference landmarks
Key exclusion criteria (9 listed)
- Patients not eligible according to abovementioned criteria
- Simultaneous extraction of impacted teeth 18 and/or 28
- Previous maxillary orthognathic surgery
- Previous Surgical Assisted Rapid Palatal Expansion (SARPE)
- Syndromic condition, including cleft lip and palate
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
accuracy of the minimally invasive approach in comparison to conventional approaches, based on 3D virtual CBCT superimposition of planning CBCT and postoperative CBCT
Time frame: at 4 weeks postoperative
2 secondary outcomes
Surgical time necessary to complete the procedure
Time frame: perioperative
Intraoperative and early postoperative complications
Time frame: within 4 weeks postoperative
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 19 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Gwen Swennen principal investigator
Division of Maxillofacial Surgery, Department of Surgery, General Hospital Saint-John Bruges, Belgium
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 Jaw Abnormalities, run by AZ Sint-Jan AV at 1 site in Belgium.
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 6 inclusion and 9 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 19 Jan 2021. 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 Belgium. 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?
accuracy of the minimally invasive approach in comparison to conventional approaches, based on 3D virtual CBCT superimposition of planning CBCT and postoperative CBCT (time frame: at 4 weeks postoperative). 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 19 Jan 2021.