Dentofacial DeformitiesorthognathicNCT06132906
Comparison Between Two Techniques to Reposition the Maxilla After le Fort 1
A study testing Orthognathic surgery (lefort1) in people with Dentofacial Deformities and Le Fort; I, run by Alexandria University at 1 site in Egypt.
Trial summary
clinical and radiographic comparison between novel locating guide design with pre-bent titanium plates and 3d printed intermediate wafer to reposition the maxilla after Le Fort 1 osteotomy in orthognathic surgery (randomized controlled clinical trial) Read more about this study
- Who is it for?
- Ages 18 to 42 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentofacial Deformities, Le Fort; I
- What is being tested?
- Orthognathic surgery (lefort1)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2022to 1 Nov 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 42 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All patients requiring Le Fort I osteotomy will be selected including those suffering from skeletal malocclusion (Class II or Class III), midface hypoplasia or vertical maxillary excess.
Who cannot join
- cleft lip and palate. skeletal disharmony due to trauma or severe facial asymmetry. significant medical condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Accuracy Between Novel Locating Guide Design With Pre-bent Titanium Plates and 3d Printed Intermediate Wafer to Reposition the Maxilla After le Fort 1 Osteotomy in Orthognathic Surgery
clinical and radiographic comparison between novel locating guide design with pre-bent titanium plates and 3d printed intermediate wafer to reposition the maxilla after Le Fort 1 osteotomy in orthognathic surgery (randomized controlled clinical trial)
Read the detailed description
Eligible patients will be allocated randomly into 2 equal groups with 7 patients in each group according to the method that will be used to reposition the maxilla by simple randomization using computer generated random numbers. Group 1 (Study group) will be treated with locating guides to reposition the maxilla with pre-bent plates on 3d model. Group 2 (Control group) will be treated with Intermediate wafer.
- Conditions
- Dentofacial Deformities, Le Fort; I
- Being tested
- Orthognathic surgery (lefort1)
- Keywords
- orthognathic, virtual planning
- Medical subject headings
- Dentofacial Deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthognathic surgery (lefort1)Procedure or surgery
- All patients will be treated under general anesthesia.
- The surgical field will be scrubbed with povidone-iodine surgical scrub solution, followed by draping of the patient with sterile towels exposing only the area of surgery.
- The surgical procedure of Le Fort I osteotomy will be performed which can be summarized as follows:
- External reference marking
- Incision and subperiosteal dissection
- Maxillary osteotomy
- Pterygomaxillary disjunction,
- Septal, vomerine, and lateral nasal osteotomies
- Down fracture
- Mobilization of the maxilla
- Application of stent in one group and the locating guide in the other group.
- Maxillary fixation
- Occlusal evaluation
- Wound debridement and closure
| Study group | Role | What they receive |
|---|---|---|
| (Study group) will be treated with locating guides to reposition the maxilla with pre-bent plates | Experimental | After le fort 1 osteotomy, locating guides will be used to reposition the maxilla with pre-bent plates. Receives: Procedure: Orthognathic surgery (lefort1) |
| (Control group) will be treated with Intermediate wafer. | Active comparator | After le fort 1 osteotomy, Intermediate wafer will be used with intermaxillary fixation. Receives: Procedure: Orthognathic surgery (lefort1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic evaluation of accuracy by superimposition
Postoperative CBCT was obtained after 2 weeks of surgery for comparison with the expected position of the maxilla in the preoperative virtual plan using 3-matic software in Mimics innovation suite software package. The preoperative planned final maxillary position was compared with the actual postoperative maxillary position by superimposing both STL models on each other with anatomical points along the orbital rims and the zygomatic arch used as reference points for alignment. The N points registration tool was used to obtain the alignment. Afterwards, using trim tool all parts were trimmed except that between the plates and the maxillary teeth crowns. Then the part comparison analysis tool was used to calculate the accuracy of the superimposition of the maxillary segment using point-based analysis algorithm after 2 weeks of surgery for comparison with the expected position of the maxilla in the preoperative virtual plan using Mimics innovation suite software.
Measured: 2 weeks
The surgery duration
The time taken between performing the Le fort 1 osteotomy till completion of plate fixation will be measured.
Measured: 1 week
Secondary outcomes (1)
Postoperative Pain
Will be assessed through a 10-point Visual Analogue Scale (VAS)
Measured: after one week, two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start15 Nov 2022
- Primary completion1 Oct 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentofacial DeformitiesStudies 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
- 14 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
- NCT06132906
- Sponsor's protocol ID
- orthognathicalexu
- Acronym
- orthognathic
- Status last verified
- Nov 2023
- First submitted
- 6 Nov 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Accuracy Between Novel Locating Guide Design With Pre-bent Titanium Plates and 3d Printed Intermediate Wafer to Reposition the Maxilla After le Fort 1 Osteotomy in Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT06132906
- Acronym / sponsor ID
- orthognathic / orthognathicalexu
- Conditions
- Dentofacial Deformities, Le Fort; I
- Keywords
- orthognathic, virtual planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 15 Nov 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.
clinical and radiographic comparison between novel locating guide design with pre-bent titanium plates and 3d printed intermediate wafer to reposition the maxilla after Le Fort 1 osteotomy in orthognathic surgery (randomized controlled clinical trial)
Detailed description
Eligible patients will be allocated randomly into 2 equal groups with 7 patients in each group according to the method that will be used to reposition the maxilla by simple randomization using computer generated random numbers. Group 1 (Study group) will be treated with locating guides to reposition the maxilla with pre-bent plates on 3d model. Group 2 (Control group) will be treated with Intermediate wafer.
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 |
|---|---|---|
| (Study group) will be treated with locating guides to reposition the maxilla with pre-bent plates | Experimental | Procedure: Orthognathic surgery (lefort1)After le fort 1 osteotomy, locating guides will be used to reposition the maxilla with pre-bent plates. |
| (Control group) will be treated with Intermediate wafer. | Active comparator | Procedure: Orthognathic surgery (lefort1)After le fort 1 osteotomy, Intermediate wafer will be used with intermaxillary fixation. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All patients requiring Le Fort I osteotomy will be selected including those suffering from skeletal malocclusion (Class II or Class III), midface hypoplasia or vertical maxillary excess.
Key exclusion criteria (1 listed)
- cleft lip and palate. skeletal disharmony due to trauma or severe facial asymmetry. significant medical condition.
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 |
|---|---|---|
| Orthognathic surgery (lefort1)1. All patients will be treated under general anesthesia. 2. The surgical field will be scrubbed with povidone-iodine surgical scrub solution, followed by draping of the patient with sterile towels exposing only the area of surgery. 3. The surgical procedure of Le Fort I osteotomy will be performed which can be summarized as follows: 1. External reference marking 2. Incision and subperiosteal dissection 3. Maxillary osteotomy 4. Pterygomaxillary disjunction, 5. Septal, vomerine, and lateral nasal osteotomies 6. Down fracture 7. Mobilization of the maxilla 8. Application of stent in one group and the locating guide in the other group. 9. Maxillary fixation 10. Occlusal evaluation 11. Wound debridement and closure | Procedure or surgery | (Control group) will be treated with Intermediate wafer., (Study group) will be treated with locating guides to reposition the maxilla with pre-bent plates |
Primary outcome
Radiographic evaluation of accuracy by superimposition
Time frame: 2 weeks
Postoperative CBCT was obtained after 2 weeks of surgery for comparison with the expected position of the maxilla in the preoperative virtual plan using 3-matic software in Mimics innovation suite software package. The preoperative planned final maxillary position was compared with the actual postoperative maxillary position by superimposing both STL models on each other with anatomical points along the orbital rims and the zygomatic arch used as reference points for alignment. The N points registration tool was used to obtain the alignment. Afterwards, using trim tool all parts were trimmed except that between the plates and the maxillary teeth crowns. Then the part comparison analysis tool was used to calculate the accuracy of the superimposition of the maxillary segment using point-based analysis algorithm after 2 weeks of surgery for comparison with the expected position of the maxilla in the preoperative virtual plan using Mimics innovation suite software.
The surgery duration
Time frame: 1 week
The time taken between performing the Le fort 1 osteotomy till completion of plate fixation will be measured.
1 secondary outcome
Postoperative Pain
Time frame: after one week, two weeks
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 15 Nov 2023.
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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 study testing Orthognathic surgery (lefort1) in people with Dentofacial Deformities and Le Fort; I, 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 1 inclusion and 1 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 15 Nov 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?
Radiographic evaluation of accuracy by superimposition (time frame: 2 weeks). The study lists 2 primary outcomes in all. 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 15 Nov 2023; AzTrials last refreshed its copy on 27 Oct 2026.