Dentofacial DeformitiesNCT05522348
Stability of Two Designs of Patient Specific Osteosynthesis For Fixation of LeFort 1 Osteotomy in Orthognathic Surgery
A study testing Stability of a two piece PSI deign in splintless maxillary orthognathic surgery and Stability of a one piece PSI deign in splintless maxillary orthognathic surgery in people with Dentofacial Deformities, run by Cairo University at 1 site in Egypt.
Trial summary
A comparison of the stability of two different designs of patient specific fixation devices for the performance of splintless computer guided le fort 1 osteotomy in orthognathic surgery workflow for the correction of a variety of dentofacial deformities Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dentofacial Deformities
- What is being tested?
- Stability of a two piece PSI deign in splintless maxillary orthognathic surgery and Stability of a one piece PSI deign in splintless maxillary orthognathic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Sep 2022to 10 Dec 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older 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 surgical correction and refusing orthodontic camouflage.
- Maxillary impaction, advancement and rotations.
- Highly motivated patients.
- Good oral hygiene.
- Patients willing for the surgical procedure and follow-up, with an informed consent
Who cannot join
- Medically compromised patients
- Uncooperative patients
- Poor oral hygiene
- Periodontal diseases
- Patients with no desire for surgical correction
- Patients with any diseases that compromise bone or soft tissue healing Patients with local pathology that interfere with the bone healing
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of oral and dental medicine
Cairo, Manial, 12613
Shady Shaker, shadymshakerr@gmail.com
About this study
Official title: Stability of Two Different Designs of Patient Specific Osteosynthesis "One Piece VS Two Piece" For The Fixation of LeFort 1 Osteotomy in Maxillary Orthognathic Surgery A Randomized Clinical Trial
A comparison of the stability of two different designs of patient specific fixation devices for the performance of splintless computer guided le fort 1 osteotomy in orthognathic surgery workflow for the correction of a variety of dentofacial deformities
Read the detailed description
- Intervention Group: -
Pre-Operative Virtual planning:
After CT examinations, further processing of the DICOM files (Digital Imaging and Communications in Medicine) will be performed using the specialized DICOM image processing software and reconstructed 3D models of the skull will be made. Stone models will be scanned using an optical scanner and stereolithographic files will be imported. Registration of the STL files with the skull model will create a composite model suitable for the construction of necessary devices. These 3D models will be used to design the custom-made cutting guides and fixation devices. The final STL files will be sent to the lab to be milled/printed.
Surgical procedure:
Routine site preparation regarding L.A injections and surgical site disinfections. A maxillary vestibular incision will be made from the maxillary second premolar on one side to the contralateral tooth. The incision will be made 5 mm above the mucogingival junction to leave an adequate cuff for closure. A full thickness mucoperiosteal flap will be reflected to expose the anterior and lateral maxillary walls. Superiorly the reflection exposes the pyriform rim, lateral nasal wall and the infraorbital nerve. Moving backwards, exposure of the zygomatico maxillary buttress is done followed by the maxillary tuberosity and finally the pterygomaxillary junction. The cutting guides will then be placed on the exposed maxilla. The cutting guides will have holes designed in them corresponding to the position of the fixation screws and a slot marking the level of the level of the Le fort 1 osteotomy which will be made using a reciprocating saw. The osteotomy is initiated and the cutting guide is removed.
The nasal septum, both lateral nasal walls and both pterygomaxillary junctions will be osteotomized using a mallet and a chisel and the maxilla finally down fractured and mobilized using Rowe's disimpaction forceps.
Without the use of inter maxillary fixation on an interocclusal wafer. the two-piece PSI will be placed and fixated above the level of the osteotomy using Mini screws. The mobile maxilla is moved until its one and only preplanned position is achieved using the PSI anatomical contours and then the maxilla is fixed. Copious irrigation is done and wound closure using an air cinch and a V-Y closure.
Post-Operative:
Immediate post-operative instructions and medications including analgesics and antibiotics will be given to the patient.
CT scan will be done 4 months post operatively. Then the preoperative and postoperative models will be superimposed to determine the accuracy of the surgically positioned maxilla, comparing it to the virtual plan.
- Control Group
The surgical procedure:
The exact same procedure will be repeated for the control group with the only difference being the fixation device which will consist of a one piece PSI spanning along the entire length of the osteotomy from one zygomaticomaxillary buttress to another.
Post-Operative:
Immediate post-operative instructions and medications including analgesics and antibiotics will be given to the patient.
CT scan will be done 4 months postoperatively.
Strategies to improve adherence to intervention protocols:
Assuring the accuracy of the patient specific fixation by printing skull models of the performed surgery and checking the plates. And such accuracy measures will be photographed and archived.
Criteria for discontinuing allocated interventions for a participant:
- Significant deviation from the virtual plan which will compromise the treatment outcome.
- Hardware failure (Non healing wound dehiscence, screw loosening, plate fracture, etc.)
Relevant concomitant care and interventions that are permitted:
- The application of postoperative elastics for minor occlusal adjustments. Relevant concomitant care that will be prohibited is the fixation of the separated maxilla in a position other than that dictated by the cutting and drilling guide
- Conditions
- Dentofacial Deformities
- Being tested
- Stability of a two piece PSI deign in splintless maxillary orthognathic surgery, Stability of a one piece PSI deign in splintless maxillary orthognathic surgery
- Keywords
- Computer guided orthognathic surgery, Splintless orthognathic surgery, Patient specific osteosynthesis, stability of le fort 1 osteotomy
- Medical subject headings
- Dentofacial Deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stability of a two piece PSI deign in splintless maxillary orthognathic surgeryProcedure or surgery
two patient fitted custom made plates will be used for the fixation of the maxilla following le fort 1 osteotomy for the correction of the dentofacial deformity and the postoperative stability will be measured using postoperative xrays
Stability of a one piece PSI deign in splintless maxillary orthognathic surgeryProcedure or surgery
one patient fitted custom made plate will be used for the fixation of the maxilla following le fort 1 osteotomy for the correction of the dentofacial deformity and the postoperative stability will be measured using postoperative xrays
| Study group | Role | What they receive |
|---|---|---|
| Stability of a two piece PSI deign in splintless maxillary orthognathic surgery | Experimental | A two piece fixation device will be used connecting the nasomaxillary and the zygomaticomaxillary buttresses on both sides Receives: Procedure: Stability of a two piece PSI deign in splintless maxillary orthognathic surgery |
| Stability of a one piece PSI deign in splintless maxillary orthognathic surgery | Active comparator | A one piece fixation device will be used extending from one zygomaticomaxillary buttress to the nasomaxillary area then just below the anterior nasal spine then to the same buttresses on the other side Receives: Procedure: Stability of a one piece PSI deign in splintless maxillary orthognathic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stability of the new maxillary position
Primary outcome will be the positional stability of the repositioned maxilla which will be measured via CT scan by superimposing the postoperative maxillary segment obtained from a 4 months postoperative CT
Measured: 4 months
Secondary outcomes (2)
Intra-operative time
stop watch is used toc calculate the intra-operative time
Measured: Intra-operative
Patient satisfaction using Visual Analogue Scale
Patient satisfaction will be gauged using VAS 3 months postoperatively
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start5 Sep 2022 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion10 Dec 2022 (estimated)
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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Model description
- randomized clinical trial parallel study and control groups equal randomization positive controlled
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shady Medhat Sabet Shaker, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522348
- Sponsor's protocol ID
- CEBD-CU-2021-10-24
- Status last verified
- Aug 2022
- First submitted
- 22 Aug 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants agreed to be part of the study but denied sharing any personal data
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stability of Two Different Designs of Patient Specific Osteosynthesis "One Piece VS Two Piece" For The Fixation of LeFort 1 Osteotomy in Maxillary Orthognathic Surgery A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05522348
- Acronym / sponsor ID
- CEBD-CU-2021-10-24
- Conditions
- Dentofacial Deformities
- Keywords
- Computer guided orthognathic surgery, Splintless orthognathic surgery, Patient specific osteosynthesis, stability of le fort 1 osteotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Sep 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 10 Dec 2022 (estimated)
- First posted
- 31 Aug 2022 (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.
A comparison of the stability of two different designs of patient specific fixation devices for the performance of splintless computer guided le fort 1 osteotomy in orthognathic surgery workflow for the correction of a variety of dentofacial deformities
Detailed description
- Intervention Group: -
Pre-Operative Virtual planning:
After CT examinations, further processing of the DICOM files (Digital Imaging and Communications in Medicine) will be performed using the specialized DICOM image processing software and reconstructed 3D models of the skull will be made. Stone models will be scanned using an optical scanner and stereolithographic files will be imported. Registration of the STL files with the skull model will create a composite model suitable for the construction of necessary devices. These 3D models will be used to design the custom-made cutting guides and fixation devices. The final STL files will be sent to the lab to be milled/printed.
Surgical procedure:
Routine site preparation regarding L.A injections and surgical site disinfections. A maxillary vestibular incision will be made from the maxillary second premolar on one side to the contralateral tooth. The incision will be made 5 mm above the mucogingival junction to leave an adequate cuff for closure. A full thickness mucoperiosteal flap will be reflected to expose the anterior and lateral maxillary walls. Superiorly the reflection exposes the pyriform rim, lateral nasal wall and the infraorbital nerve. Moving backwards, exposure of the zygomatico maxillary buttress is done followed by the maxillary tuberosity and finally the pterygomaxillary junction. The cutting guides will then be placed on the exposed maxilla. The cutting guides will have holes designed in them corresponding to the position of the fixation screws and a slot marking the level of the level of the Le fort 1 osteotomy which will be made using a reciprocating saw. The osteotomy is initiated and the cutting guide is removed.
The nasal septum, both lateral nasal walls and both pterygomaxillary junctions will be osteotomized using a mallet and a chisel and the maxilla finally down fractured and mobilized using Rowe's disimpaction forceps.
Without the use of inter maxillary fixation on an interocclusal wafer. the two-piece PSI will be placed and fixated above the level of the osteotomy using Mini screws. The mobile maxilla is moved until its one and only preplanned position is achieved using the PSI anatomical contours and then the maxilla is fixed. Copious irrigation is done and wound closure using an air cinch and a V-Y closure.
Post-Operative:
Immediate post-operative instructions and medications including analgesics and antibiotics will be given to the patient.
CT scan will be done 4 months post operatively. Then the preoperative and postoperative models will be superimposed to determine the accuracy of the surgically positioned maxilla, comparing it to the virtual plan.
- Control Group
The surgical procedure:
The exact same procedure will be repeated for the control group with the only difference being the fixation device which will consist of a one piece PSI spanning along the entire length of the osteotomy from one zygomaticomaxillary buttress to another.
Post-Operative:
Immediate post-operative instructions and medications including analgesics and antibiotics will be given to the patient.
CT scan will be done 4 months postoperatively.
Strategies to improve adherence to intervention protocols:
Assuring the accuracy of the patient specific fixation by printing skull models of the performed surgery and checking the plates. And such accuracy measures will be photographed and archived.
Criteria for discontinuing allocated interventions for a participant:
- Significant deviation from the virtual plan which will compromise the treatment outcome.
- Hardware failure (Non healing wound dehiscence, screw loosening, plate fracture, etc.)
Relevant concomitant care and interventions that are permitted:
- The application of postoperative elastics for minor occlusal adjustments. Relevant concomitant care that will be prohibited is the fixation of the separated maxilla in a position other than that dictated by the cutting and drilling guide
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized clinical trial parallel study and control groups equal randomization positive controlled
| Arm | Type | Receives |
|---|---|---|
| Stability of a two piece PSI deign in splintless maxillary orthognathic surgery | Experimental | Procedure: Stability of a two piece PSI deign in splintless maxillary orthognathic surgeryA two piece fixation device will be used connecting the nasomaxillary and the zygomaticomaxillary buttresses on both sides |
| Stability of a one piece PSI deign in splintless maxillary orthognathic surgery | Active comparator | Procedure: Stability of a one piece PSI deign in splintless maxillary orthognathic surgeryA one piece fixation device will be used extending from one zygomaticomaxillary buttress to the nasomaxillary area then just below the anterior nasal spine then to the same buttresses on the other side |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients with dentofacial deformity: skeletal class 2, class 3, vertical maxillary excess, Facial asymmetry.
- Patient seeking definitive surgical correction and refusing orthodontic camouflage.
- Maxillary impaction, advancement and rotations.
- Highly motivated patients.
- Good oral hygiene.
Key exclusion criteria (6 listed)
- Medically compromised patients
- Uncooperative patients
- Poor oral hygiene
- Periodontal diseases
- Patients with no desire for surgical correction
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 |
|---|---|---|
| Stability of a two piece PSI deign in splintless maxillary orthognathic surgerytwo patient fitted custom made plates will be used for the fixation of the maxilla following le fort 1 osteotomy for the correction of the dentofacial deformity and the postoperative stability will be measured using postoperative xrays | Procedure or surgery | Stability of a two piece PSI deign in splintless maxillary orthognathic surgery |
| Stability of a one piece PSI deign in splintless maxillary orthognathic surgeryone patient fitted custom made plate will be used for the fixation of the maxilla following le fort 1 osteotomy for the correction of the dentofacial deformity and the postoperative stability will be measured using postoperative xrays | Procedure or surgery | Stability of a one piece PSI deign in splintless maxillary orthognathic surgery |
Primary outcome
Stability of the new maxillary position
Time frame: 4 months
Primary outcome will be the positional stability of the repositioned maxilla which will be measured via CT scan by superimposing the postoperative maxillary segment obtained from a 4 months postoperative CT
2 secondary outcomes
Intra-operative time
Time frame: Intra-operative
Patient satisfaction using Visual Analogue Scale
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Individual participant dataSharing planned: No. Participants agreed to be part of the study but denied sharing any personal data
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stability of a two piece PSI deign in splintless maxillary orthognathic surgery and Stability of a one piece PSI deign in splintless maxillary orthognathic surgery in people with Dentofacial Deformities, run by Cairo 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 6 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: status not confirmed, as of the sponsor's last update on 2 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shady Shaker, B.D.S. (+201227655079, shadymshakerr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stability of the new maxillary position (time frame: 4 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 2 Sep 2022.