Cleft Lip PalatePhase 4NCT07423806
Evaluation of Modified Le Fort I Osteotomy for Treating Cleft Lip and Palate Patients
A Phase 4 study testing segmental Le Fort I (SLF-1) osteotomy in people with Cleft Lip Palate and Class III Skeletal Malocclusion, run by Alexandria University at 1 site in Egypt.
Trial summary
Nine adults with Angle class III relation and persistent alveolar bone defect due to CL/P deformity were included. SLF-1 maxillary advancement was performed. Lateral profile analysis and alveolar bone defect volume were assessed before and after the surgery. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Cleft Lip Palate, Class III Skeletal Malocclusion, Le Fort; I
- What is being tested?
- segmental Le Fort I (SLF-1) osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 30 Jun 2023
- Phase
- Phase 4
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Presence of a maxillary skeletal deformity requiring correction
- Presence of an alveolar cleft deformity not previously treated at the mixed dentition stage.
- Patients having an alveolar cleft previously treated but a residual deformity is still present.
Who cannot join
- Class 1 occlusion
- Dental malocclusion not associated with dentofacial deformities.
- Medical contraindication to general anesthesia
- Psychological instability
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Alexandria University, Champollion St., Azarita, Alexandria, Egypt
Alexandria, 21514
About this study
Nine adults with Angle class III relation and persistent alveolar bone defect due to CL/P deformity were included. SLF-1 maxillary advancement was performed. Lateral profile analysis and alveolar bone defect volume were assessed before and after the surgery.
- Being tested
- segmental Le Fort I (SLF-1) osteotomy
- Keywords
- Cleft Lip Palate, Class III Skeletal Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
segmental Le Fort I (SLF-1) osteotomyProcedure or surgery
segmental Le Fort I (SLF-1) osteotomy technique for repair of facial deformities of cleft lip and palate patients, as regards to the stability and predictability and cleft-alveolar gap dimension changes
| Study group | Role | What they receive |
|---|---|---|
| adults with Angle class III relation and persistent alveolar bone defect due to CL/P deformity | Experimental | Not described Receives: Procedure: segmental Le Fort I (SLF-1) osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar Gap Measurement
CBCT DICOM images of the patient's scan were imported into 3D Slicer software (BWH, USA). Volume rendering was calculated based on selection of region between the base of the nose superiorly, and edges of the alveolar cleft inferiorly, posteriorly, anteriorly, and on both sides. Segmentation of air present in this region was done, and exported in Standard Tessellation Language (stl) file format. The volume of this file was calculated to give an estimate of volume of the alveolar defect, using Meshmixer™ Version 3.5.474 (Autodesk®, California, USA). 6 months' postoperative CBCT and preoperative CBCT. were compared to determine the amount of change.
Measured: 6 months
Secondary outcomes (1)
amount of planned maxillary advancement compared to actual amount of advancement achieved after the operation
Planned amount of advancement was extracted from the digital planning procedure for each subject, and this was compared with the actual amount of advancement achieved from the surgery. This actual amount of advancement was calculated by superimposing the 3D-generated skulls of the preoperative CBCT on the 3D-generated skull of the postoperative CBCT, and a point placed on the upper first molar of each of the preoperative and postoperative CBCT. The distance between the two points is the amount of advancemenet achieved.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Jan 2020
- Primary completion1 Jan 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Lip PalateStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423806
- Sponsor's protocol ID
- 0026-05/2019
- Status last verified
- Feb 2026
- First submitted
- 14 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Modified Le Fort I Osteotomy for Treating Cleft Lip and Palate Patients
- ClinicalTrials.gov ID
- NCT07423806
- Acronym / sponsor ID
- 0026-05/2019
- Keywords
- Cleft Lip Palate, Class III Skeletal Malocclusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 20 Feb 2026 (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.
Nine adults with Angle class III relation and persistent alveolar bone defect due to CL/P deformity were included. SLF-1 maxillary advancement was performed. Lateral profile analysis and alveolar bone defect volume were assessed before and after the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adults with Angle class III relation and persistent alveolar bone defect due to CL/P deformity | Experimental | Procedure: segmental Le Fort I (SLF-1) osteotomy |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Presence of a maxillary skeletal deformity requiring correction
- Presence of an alveolar cleft deformity not previously treated at the mixed dentition stage.
- Patients having an alveolar cleft previously treated but a residual deformity is still present.
Key exclusion criteria (4 listed)
- Class 1 occlusion
- Dental malocclusion not associated with dentofacial deformities.
- Medical contraindication to general anesthesia
- Psychological instability
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 |
|---|---|---|
| segmental Le Fort I (SLF-1) osteotomysegmental Le Fort I (SLF-1) osteotomy technique for repair of facial deformities of cleft lip and palate patients, as regards to the stability and predictability and cleft-alveolar gap dimension changes | Procedure or surgery | adults with Angle class III relation and persistent alveolar bone defect due to CL/P deformity |
Primary outcome
Alveolar Gap Measurement
Time frame: 6 months
CBCT DICOM images of the patient's scan were imported into 3D Slicer software (BWH, USA). Volume rendering was calculated based on selection of region between the base of the nose superiorly, and edges of the alveolar cleft inferiorly, posteriorly, anteriorly, and on both sides. Segmentation of air present in this region was done, and exported in Standard Tessellation Language (stl) file format. The volume of this file was calculated to give an estimate of volume of the alveolar defect, using Meshmixer™ Version 3.5.474 (Autodesk®, California, USA). 6 months' postoperative CBCT and preoperative CBCT. were compared to determine the amount of change.
1 secondary outcome
amount of planned maxillary advancement compared to actual amount of advancement achieved after the operation
Time frame: 6 month
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 20 Feb 2026.
- Individual participant dataSharing planned: Yes
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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.
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 Phase 4 study testing segmental Le Fort I (SLF-1) osteotomy in people with Cleft Lip Palate and Class III Skeletal Malocclusion, run by Alexandria University 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 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 20 Feb 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Alveolar Gap Measurement (time frame: 6 months). 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 20 Feb 2026.