Abnormality of Facial SkeletonNCT06160661
Radiographic Assessment of Three Dimensional Mandibular Position Using Splint-less Patient Specific Implant
A study testing mandibular saggital split osteotomy in people with Abnormality of Facial Skeleton, run by Ain Shams University at 1 site in Egypt.
Trial summary
The purpose of this study was to assess the accuracy of a splint-less approach for mandibular jaw orthognathic surgery. This approach utilized a personalized orthognathic surgical guide (POSG) system, which comprised a set of cutting guides and 3D printed custom titanium fixation plates for bilateral sagittal split… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Abnormality of Facial Skeleton
- What is being tested?
- mandibular saggital split osteotomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Jan 2024
- 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
- Patients suffering from skeletal deformity requiring mandibular orthognathic surgery (Bilateral sagittal splitting osteotomy).
- Patients should be free from any systemic disease that may affect normal bone healing and predictable outcome.
Who cannot join
- Patients with metabolic bone disease that affects bone healing.
- Intra-bony lesions that may affect the osteotomy healing.
- Patients with history of radiotherapy on the head and neck region
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry
Cairo
abanoub fayez, PhDcandidate
About this study
Official title: Radiographic Assessment of Three Dimensional Mandibular Position Using Splint-less Patient Specific Implant Following Bilateral Sagittal Split Osteotomy
The purpose of this study was to assess the accuracy of a splint-less approach for mandibular jaw orthognathic surgery. This approach utilized a personalized orthognathic surgical guide (POSG) system, which comprised a set of cutting guides and 3D printed custom titanium fixation plates for bilateral sagittal split osteotomies (BSSOs).
The cutting guides were first used to predrill screw holes and guide osteotomies.
The custom plates were then used to reposition and stabilize the bony segments as planned, without the use of surgical splints or any additional tool such as surgical navigation
Read the detailed description
Surgical technique:
The buccal bony surface of the mandible was exposed as a routine sagittal split osteotomy. First, the mandibular cutting guide was installed using the tooth-borne splint portion of the guide.
Second, the lower portion of the guide was temporarily fixed with titanium screws through the designed screw holes on the guide. The planned margins for vertical osteotomy/ ostectomy were then marked by a pencil.
Once the cutting guide was removed, the sagittal split osteotomy was completed as usual. Finally, the distal and proximal segments were fixed together using the custom plates and screw holes that were used by the cutting guide.
Accuracy of preoperative surgical planning, and validation of the use of patient specific implants (PSI) in bilateral sagittal split osteotomy (BSSO) by comparing the planned outcomes to the actual postoperative outcomes by two methos.
A)Evaluation the discrepancy between planned and obtained post-operative position of the mandibular plates, rami, and occlusion by analyzing the discrepancies in terms of rotation (roll, pitch and yaw) and translation (antero-posterior, lateral and vertical). These movements were determined by incorporating the segments in homologous bounding-boxes, aligning the planned model to the post-op result colorimetric map inspection.
- Measurements of the linear differences between the planned and postoperative positions of the mandibular midlines, the chin, and the gonial angle.
- Conditions
- Abnormality of Facial Skeleton
- Being tested
- mandibular saggital split osteotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mandibular saggital split osteotomyDevice
orthognathic surgery
| Study group | Role | What they receive |
|---|---|---|
| single arm study | Experimental | The purpose of this study was to assess the accuracy of a splint-less approach for mandibular jaw orthognathic surgery. This approach utilized a personalized orthognathic surgical guide (POSG) system, which comprised a set of cutting guides and 3D printed custom titanium fixation plates for bilateral sagittal split osteotomies (BSSOs).
The cutting guides were first used to predrill screw holes and guide osteotomies. The custom plates were then used to reposition and stabilize the bony segments as planned, without the use of surgical splints or any additional tool such as surgical navigation Receives: Device: mandibular saggital split osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
device feasibility and eligibility for use of PSI
The primary outcome of this study is to assess the accuracy of preoperative surgical planning, and validation feasibility of the use of patient specific implants (PSI) in bilateral sagittal split osteotomy (BSSO) by comparing the planned outcomes to the actual postoperative outcomes by two measurement tools (MIMICS software, and DICOM file of pre and post operative CT) . By using software we can superimpose the DICOM files of CT and linear differences in millimetres between fixed points in CT can be obtained to assess the accuracy of the outcome.
Measured: 1 week postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start1 Jan 2022
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormality of Facial SkeletonStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abanoub Fayez Aziz, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160661
- Sponsor's protocol ID
- FDASU-Rec ID032243
- Status last verified
- Dec 2023
- First submitted
- 3 Nov 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Assessment of Three Dimensional Mandibular Position Using Splint-less Patient Specific Implant Following Bilateral Sagittal Split Osteotomy
- ClinicalTrials.gov ID
- NCT06160661
- Acronym / sponsor ID
- FDASU-Rec ID032243
- Conditions
- Abnormality of Facial Skeleton
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 7 Dec 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.
The purpose of this study was to assess the accuracy of a splint-less approach for mandibular jaw orthognathic surgery. This approach utilized a personalized orthognathic surgical guide (POSG) system, which comprised a set of cutting guides and 3D printed custom titanium fixation plates for bilateral sagittal split osteotomies (BSSOs).
The cutting guides were first used to predrill screw holes and guide osteotomies.
The custom plates were then used to reposition and stabilize the bony segments as planned, without the use of surgical splints or any additional tool such as surgical navigation
Detailed description
Surgical technique:
The buccal bony surface of the mandible was exposed as a routine sagittal split osteotomy. First, the mandibular cutting guide was installed using the tooth-borne splint portion of the guide.
Second, the lower portion of the guide was temporarily fixed with titanium screws through the designed screw holes on the guide. The planned margins for vertical osteotomy/ ostectomy were then marked by a pencil.
Once the cutting guide was removed, the sagittal split osteotomy was completed as usual. Finally, the distal and proximal segments were fixed together using the custom plates and screw holes that were used by the cutting guide.
Accuracy of preoperative surgical planning, and validation of the use of patient specific implants (PSI) in bilateral sagittal split osteotomy (BSSO) by comparing the planned outcomes to the actual postoperative outcomes by two methos.
A)Evaluation the discrepancy between planned and obtained post-operative position of the mandibular plates, rami, and occlusion by analyzing the discrepancies in terms of rotation (roll, pitch and yaw) and translation (antero-posterior, lateral and vertical). These movements were determined by incorporating the segments in homologous bounding-boxes, aligning the planned model to the post-op result colorimetric map inspection.
- Measurements of the linear differences between the planned and postoperative positions of the mandibular midlines, the chin, and the gonial angle.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm study | Experimental | Device: mandibular saggital split osteotomyThe purpose of this study was to assess the accuracy of a splint-less approach for mandibular jaw orthognathic surgery. This approach utilized a personalized orthognathic surgical guide (POSG) system, which comprised a set of cutting guides and 3D printed custom titanium fixation plates for bilateral sagittal split osteotomies (BSSOs). The cutting guides were first used to predrill screw holes and guide osteotomies. The custom plates were then used to reposition and stabilize the bony segments as planned, without the use of surgical splints or any additional tool such as surgical navigation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients suffering from skeletal deformity requiring mandibular orthognathic surgery (Bilateral sagittal splitting osteotomy).
- Patients should be free from any systemic disease that may affect normal bone healing and predictable outcome.
Key exclusion criteria (3 listed)
- Patients with metabolic bone disease that affects bone healing.
- Intra-bony lesions that may affect the osteotomy healing.
- Patients with history of radiotherapy on the head and neck region
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 |
|---|---|---|
| mandibular saggital split osteotomyorthognathic surgery | Device | single arm study |
Primary outcome
device feasibility and eligibility for use of PSI
Time frame: 1 week postoperative
The primary outcome of this study is to assess the accuracy of preoperative surgical planning, and validation feasibility of the use of patient specific implants (PSI) in bilateral sagittal split osteotomy (BSSO) by comparing the planned outcomes to the actual postoperative outcomes by two measurement tools (MIMICS software, and DICOM file of pre and post operative CT) . By using software we can superimpose the DICOM files of CT and linear differences in millimetres between fixed points in CT can be obtained to assess the accuracy of the outcome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: No
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 mandibular saggital split osteotomy in people with Abnormality of Facial Skeleton, run by Ain Shams 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 2 inclusion and 3 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 7 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact abanoub Aziz, PhDcandidate (020 01202248330, abanoubfayez@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
device feasibility and eligibility for use of PSI (time frame: 1 week postoperative). 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 7 Dec 2023.