Le Fort; INCT05908370
Accuracy of LeFort I Osteotomy Fixation Using Two Plates Versus Four Plates Patient Specific Osteosynthesis
A study testing Maxillary orthognathic surgery using 4 patient specific osteosynthesis (4-Plates) in people with Le Fort; I, run by Future University in Egypt at 1 site in Egypt.
Trial summary
Virtual Surgical planning (VSP) has significantly improved many aspects of oral and maxillofacial surgery. A very important aspect is surgical accuracy and precise transfer of the surgical plan to the operating theatre and reduction of operative time. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Le Fort; I
- What is being tested?
- Maxillary orthognathic surgery using 4 patient specific osteosynthesis (4-Plates)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 30 Jan 2023
- Phase
- Interventional
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult patients with dentofacial deformity: skeletal class 2, class 3, vertical maxillary excess, Facial asymmetry.
- Patient seeking definitive maxillary or bimaxillary surgical correction and refusing orthodontic camouflage.
- Patient due to receive a non- segmental Le Fort I osteotomy as part of their orthognathic surgery.
- Patient age at least 18 years
- Highly motivated patients.
- Good oral hygiene.
- Patients willing for follow-up, with an informed consent
Who cannot join
- Medically compromised patients redeeming unfit for general anesthesia
- Pregnancy
- patient had a known allergy to titanium
- Patients with any diseases that may compromise bone or soft tissue healing.
- Patients with local pathosis that may interfere with the bone healing.
- Patient with previous maxillary surgery having hardware that may compromise accuracy of the virtual planning
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Oral and Dental Medicine, Future Univerisity in Egypt
Cairo, 11835
About this study
Official title: Accuracy of LeFort I Osteotomy Fixation Using Two Plates Versus Four Plates Patient Specific Osteosynthesis. A Randomized Clinical Trial
Virtual Surgical planning (VSP) has significantly improved many aspects of oral and maxillofacial surgery. A very important aspect is surgical accuracy and precise transfer of the surgical plan to the operating theatre and reduction of operative time. Conventional treatment planning for orthognathic surgery, although proven to be reliable, has many drawbacks. Computer guided splintless maxillary orthognathic surgery has been recently performed with predictable outcomes. More than one design of PS osteosynthesis has been used in recent trials. Nevertheless, which design is more superior to the other is a topic yet to be addressed. Either a one-piece fixation device spanning the length of the Le Fort 1 osteotomy or the fixation can be provided by more than one device placed at the load bearing buttresses. The superiority of 4 fixating patients specific plates compared to the other will be determined after evaluating many outcomes including accuracy, intra operative time, post-operative complications.
The goal is to take a step towards determining which design is the best for performing splintless maxillary orthognathic surgery in terms of accuracy and least complications for the correction of prevalent dentofacial deformities.
Beside the evaluation of accuracy, the two different designs will be compared in terms of operative time and post-operative complications.
- Conditions
- Le Fort; I
- Being tested
- Maxillary orthognathic surgery using 4 patient specific osteosynthesis (4-Plates)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary orthognathic surgery using 4 patient specific osteosynthesis (4-Plates)Procedure or surgery
Maxillary orthognathic surgery using 4 patient specific osteosynthesis (4-Plates)
| Study group | Role | What they receive |
|---|---|---|
| Maxillary orthognathic surgery using 4 patient specific osteosynthesis (4-Plates) | Experimental | Not described Receives: Procedure: Maxillary orthognathic surgery using 4 patient specific osteosynthesis (4-Plates) |
| Maxillary orthognathic surgery using 2 patient specific osteosynthesis (2-Plates) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
Primary outcome will be the positional accuracy of the repositioned maxilla which will be measured via CT scan by superimposing the postoperative maxillary segment obtained from a 1-week postoperative CT with the planned one and the difference is calculated in mm.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Jan 2022
- Primary completion30 Dec 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Le Fort; IStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed Hossam Mohamed Sabri Ibrahim, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908370
- Sponsor's protocol ID
- (25)11-2021
- Status last verified
- Jun 2023
- First submitted
- 29 May 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of LeFort I Osteotomy Fixation Using Two Plates Versus Four Plates Patient Specific Osteosynthesis. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05908370
- Acronym / sponsor ID
- (25)11-2021
- Conditions
- Le Fort; I
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 18 Jun 2023 (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.
Virtual Surgical planning (VSP) has significantly improved many aspects of oral and maxillofacial surgery. A very important aspect is surgical accuracy and precise transfer of the surgical plan to the operating theatre and reduction of operative time. Conventional treatment planning for orthognathic surgery, although proven to be reliable, has many drawbacks. Computer guided splintless maxillary orthognathic surgery has been recently performed with predictable outcomes. More than one design of PS osteosynthesis has been used in recent trials. Nevertheless, which design is more superior to the other is a topic yet to be addressed. Either a one-piece fixation device spanning the length of the Le Fort 1 osteotomy or the fixation can be provided by more than one device placed at the load bearing buttresses. The superiority of 4 fixating patients specific plates compared to the other will be determined after evaluating many outcomes including accuracy, intra operative time, post-operative complications.
The goal is to take a step towards determining which design is the best for performing splintless maxillary orthognathic surgery in terms of accuracy and least complications for the correction of prevalent dentofacial deformities.
Beside the evaluation of accuracy, the two different designs will be compared in terms of operative time and post-operative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maxillary orthognathic surgery using 4 patient specific osteosynthesis (4-Plates) | Experimental | Procedure: Maxillary orthognathic surgery using 4 patient specific osteosynthesis (4-Plates) |
| Maxillary orthognathic surgery using 2 patient specific osteosynthesis (2-Plates) | No intervention | – |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adult patients with dentofacial deformity: skeletal class 2, class 3, vertical maxillary excess, Facial asymmetry.
- Patient seeking definitive maxillary or bimaxillary surgical correction and refusing orthodontic camouflage.
- Patient due to receive a non- segmental Le Fort I osteotomy as part of their orthognathic surgery.
- Patient age at least 18 years
- Highly motivated patients.
Key exclusion criteria (6 listed)
- Medically compromised patients redeeming unfit for general anesthesia
- Pregnancy
- patient had a known allergy to titanium
- Patients with any diseases that may compromise bone or soft tissue healing.
- Patients with local pathosis that may interfere with the bone healing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maxillary orthognathic surgery using 4 patient specific osteosynthesis (4-Plates)Maxillary orthognathic surgery using 4 patient specific osteosynthesis (4-Plates) | Procedure or surgery | Maxillary orthognathic surgery using 4 patient specific osteosynthesis (4-Plates) |
Primary outcome
Accuracy
Time frame: 1 week
Primary outcome will be the positional accuracy of the repositioned maxilla which will be measured via CT scan by superimposing the postoperative maxillary segment obtained from a 1-week postoperative CT with the planned one and the difference is calculated in mm.
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 18 Jun 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Le Fort; I
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
Not yet recruitingObservational study
Finite Element Modelling of Le Fort I Osteotomy Fixation : PSI vs Miniplates
Malocclusion
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maxillary orthognathic surgery using 4 patient specific osteosynthesis (4-Plates) in people with Le Fort; I, run by Future University in Egypt at 1 site in Egypt.
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 7 inclusion and 6 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 18 Jun 2023. 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 Egypt. 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 (time frame: 1 week). 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 18 Jun 2023.