Orthognathic SurgerycustomorthoNCT06188403
Comparison Between Prebent Plates and Custom Plates After le Fort 1 in Orthognathic Surgery
A study testing Orthognathic surgery (lefort1) in people with Orthognathic Surgery, run by Alexandria University at 1 site in Egypt.
Trial summary
patients with dentofacial deformities , who needs lefort 1 osteotomy to correct position of maxilla , are divided into two groups: one group receives custom titanium plates which is patient specific and the other group receives prebent titanium plates done on printed postop plan model before surgery. Read more about this study
- Who is it for?
- Ages 18 to 42 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthognathic Surgery
- 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 Mar 2023to 20 Oct 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
- . Patients with non-syndromic dentofacial deformity requiring Le Fort I with or without bimaxillary osteotomy.
Who cannot join
- Patients with acute infection at surgery site.
- Patient with Systemic disorders contraindicating surgery.
- Smokers.
- Alcohol or drug abuse is prohibited.
- patients who suffered from craniofacial syndrome.
- patients who had previous orthognathic surgery.
- patients who had previous maxillary or mandibular trauma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Radiographic Accuracy Between Pre-bent Titanium Plates and 3D Customized Titanium Plates After le Fort 1 Osteotomy in Orthognathic Surgery
patients with dentofacial deformities , who needs lefort 1 osteotomy to correct position of maxilla , are divided into two groups: one group receives custom titanium plates which is patient specific and the other group receives prebent titanium plates done on printed postop plan model before surgery.
- Conditions
- Orthognathic Surgery
- Being tested
- Orthognathic surgery (lefort1)
- Keywords
- orthognathic, virtual planning, custom plates
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
Also called Dentofacial surgery
Lefort 1 osteotomy to reposition the maxilla using two different techniques to achieve more accurate results , one with guide for cutting and placing pre bent stock plates and the other method using custom titanium plates with guide for cutting and placing the plate
| Study group | Role | What they receive |
|---|---|---|
| (group one) will be treated with custom titanium plates and guide to reposition the maxilla | Active comparator | 7 patients are included in this arm. Le Fort I osteotomy using CAD CAM surgical guide and 3Dcustomized plate are placed to reposition the maxilla according to the virtual surgical planning. Receives: Procedure: Orthognathic surgery (lefort1) |
| (group 2) will be treated with prebent titanium plates | Active comparator | 7 patients are included in this arm. le fort 1 osteotomy using surgical guide and pre-bent stock titanium plates are used after their adaptation on the model of postoperative plan. Receives: Procedure: Orthognathic surgery (lefort1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic accuracy between postoperative plan and postoperative result.
Cone Beam Computed tomography (CBCT) is used at 1 month to assess surgical outcome by comparing the clinical results with the virtually planned outcome.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start15 Mar 2023
- Primary completion1 Sep 2023
- Study completion20 Oct 2023
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
- 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
- NCT06188403
- Sponsor's protocol ID
- Orthognathic2
- Acronym
- customortho
- Status last verified
- Dec 2023
- First submitted
- 9 Dec 2023
- Last updated
- 3 Jan 2024
- 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 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Radiographic Accuracy Between Pre-bent Titanium Plates and 3D Customized Titanium Plates After le Fort 1 Osteotomy in Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT06188403
- Acronym / sponsor ID
- customortho / Orthognathic2
- Conditions
- Orthognathic Surgery
- Keywords
- orthognathic, virtual planning, custom plates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 3 Jan 2024 (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.
patients with dentofacial deformities , who needs lefort 1 osteotomy to correct position of maxilla , are divided into two groups: one group receives custom titanium plates which is patient specific and the other group receives prebent titanium plates done on printed postop plan model before surgery.
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 |
|---|---|---|
| (group one) will be treated with custom titanium plates and guide to reposition the maxilla | Active comparator | Procedure: Orthognathic surgery (lefort1)7 patients are included in this arm. Le Fort I osteotomy using CAD CAM surgical guide and 3Dcustomized plate are placed to reposition the maxilla according to the virtual surgical planning. |
| (group 2) will be treated with prebent titanium plates | Active comparator | Procedure: Orthognathic surgery (lefort1)7 patients are included in this arm. le fort 1 osteotomy using surgical guide and pre-bent stock titanium plates are used after their adaptation on the model of postoperative plan. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- . Patients with non-syndromic dentofacial deformity requiring Le Fort I with or without bimaxillary osteotomy.
Key exclusion criteria (7 listed)
- Patients with acute infection at surgery site.
- Patient with Systemic disorders contraindicating surgery.
- Smokers.
- Alcohol or drug abuse is prohibited.
- patients who suffered from craniofacial syndrome.
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)Also: Dentofacial surgeryLefort 1 osteotomy to reposition the maxilla using two different techniques to achieve more accurate results , one with guide for cutting and placing pre bent stock plates and the other method using custom titanium plates with guide for cutting and placing the plate | Procedure or surgery | (group 2) will be treated with prebent titanium plates, (group one) will be treated with custom titanium plates and guide to reposition the maxilla |
Primary outcome
Radiographic accuracy between postoperative plan and postoperative result.
Time frame: one month
Cone Beam Computed tomography (CBCT) is used at 1 month to assess surgical outcome by comparing the clinical results with the virtually planned outcome.
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 3 Jan 2024.
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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 Orthognathic Surgery, 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 7 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 3 Jan 2024. 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 accuracy between postoperative plan and postoperative result. (time frame: one month). 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 3 Jan 2024.