Mandible PrognathismBSSONCT07222904
Evaluation of the Accuracy of Patient Specific Implant in Fixation of Mandibular Sagittal Split Osteotomy
A study testing PSI in people with Mandible Prognathism and Mandibular Retrognathism, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial summary
Study was Conducted on Patients were need BSSO Using PSI for reposition and fixation Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Mandible Prognathism, Mandibular Retrognathism
- What is being tested?
- PSI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2023to 20 May 2025
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age range of patients 18-40 years old, with no gender prediction, able to read and sign the informed consent.
- Patients with skeletal class II or class III who are in need of mandibular orthognathic surgery.
Who cannot join
- Patients who had previous orthognathic surgery.
- Patients with previous severe facial trauma history or fracture mandible.
- Patients with congenital facial asymmetry.
- Patients with systemic diseases and immunocompromised patient.
Trial locations and contacts
1 site in 1 country.
About this study
Study was Conducted on Patients were need BSSO Using PSI for reposition and fixation
Read the detailed description
A prospective study was conducted, and it included 8 patients. All patients underwent mandibular sagittal split osteotomy (BSSO) using PSI for repositioning and fixation. All patients were followed up clinically for immediate,1,3,6 weeks, and 3 months postoperatively after the surgical operation to assess the occlusion, presence of numbness, bleeding, and possible temporomandibular joint (TMJ) changes. All patients underwent immediate and 3 months Ortho pantomogram, postoperative CT were superimposed to the planned preoperative CT scan to evaluate the accuracy of PSI in fixation and merging of Digital dental model to the postoperative CT scan.
- Conditions
- Mandible Prognathism, Mandibular Retrognathism
- Being tested
- PSI
- Keywords
- Mandibular orthognathic, BSSO, Virtual planning
- Medical subject headings
- Malocclusion, Angle Class III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSIDevice
orthognathic surgery BSSO using PSI
| Study group | Role | What they receive |
|---|---|---|
| BSSO using PSI | Experimental | 8 Patients underwent bilateral sagittal split Osteotomy fixed with patient' specific implants Receives: Device: PSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of PSI and bony segment movements
Measurements using CT software after superimposition using (Mimics and 3-Matic) through fixation landmark points on both virtually planned repositioned mandible and the actual postoperative mandible, all in identical locations. Then linear measurements were performed between defined anatomical landmarks on both models using Measure distance tool, as well as between each landmark and the constructed reference planes
Measured: Baseline (preoperative), immediate postoperative, and 3-month postoperative follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2025
- Study start10 Jan 2023
- Primary completion15 Apr 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandible PrognathismStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eman Ashour, Faculty of Dental Medicine for Girls
- Investigators
- Hatem AlAhmady, Professor, Study chair, Professor of maxillofacial surgery department azhar university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222904
- Sponsor's protocol ID
- OR SUR-108-2-1
- Acronym
- BSSO
- Status last verified
- Oct 2025
- First submitted
- 27 Oct 2025
- Last updated
- 30 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Accuracy of Patient Specific Implant in Fixation of Mandibular Sagittal Split Osteotomy
- ClinicalTrials.gov ID
- NCT07222904
- Acronym / sponsor ID
- BSSO / OR SUR-108-2-1
- Conditions
- Mandible Prognathism, Mandibular Retrognathism
- Keywords
- Mandibular orthognathic, BSSO, Virtual planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 30 Oct 2025 (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.
Study was Conducted on Patients were need BSSO Using PSI for reposition and fixation
Detailed description
A prospective study was conducted, and it included 8 patients. All patients underwent mandibular sagittal split osteotomy (BSSO) using PSI for repositioning and fixation. All patients were followed up clinically for immediate,1,3,6 weeks, and 3 months postoperatively after the surgical operation to assess the occlusion, presence of numbness, bleeding, and possible temporomandibular joint (TMJ) changes. All patients underwent immediate and 3 months Ortho pantomogram, postoperative CT were superimposed to the planned preoperative CT scan to evaluate the accuracy of PSI in fixation and merging of Digital dental model to the postoperative CT scan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BSSO using PSI | Experimental | Device: PSI8 Patients underwent bilateral sagittal split Osteotomy fixed with patient' specific implants |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age range of patients 18-40 years old, with no gender prediction, able to read and sign the informed consent.
- Patients with skeletal class II or class III who are in need of mandibular orthognathic surgery.
Key exclusion criteria (4 listed)
- Patients who had previous orthognathic surgery.
- Patients with previous severe facial trauma history or fracture mandible.
- Patients with congenital facial asymmetry.
- Patients with systemic diseases and immunocompromised patient.
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 |
|---|---|---|
| PSIorthognathic surgery BSSO using PSI | Device | BSSO using PSI |
Primary outcome
Accuracy of PSI and bony segment movements
Time frame: Baseline (preoperative), immediate postoperative, and 3-month postoperative follow-up.
Measurements using CT software after superimposition using (Mimics and 3-Matic) through fixation landmark points on both virtually planned repositioned mandible and the actual postoperative mandible, all in identical locations. Then linear measurements were performed between defined anatomical landmarks on both models using Measure distance tool, as well as between each landmark and the constructed reference planes
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 30 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Mandible Prognathism
RecruitingObservational study
Natural History of Craniofacial Anomalies and Developmental Growth Variants
Prognathism, Retrognathism
Not yet recruiting
Treatment of Mandibular Overjet in Children With Maxillary Retrognathism
Maxillary Retrognathism, Children
Recruiting
Nano Coated Orthodontic Miniscrews for en Mass Retraction of the Upper Arch
Class I Malocclusion, Maxillary Prognathism
RecruitingObservational study
Facial Conformation Meshes for Orthognathic Surgery
Orthognathic Surgical Procedures
Not yet recruitingObservational study
Incidence of Body Dysmorphic Disorder (BDD) in a Population of Patients Undergoing Orthognathic Surgery
Orthognathic Surgical Procedures, Psychiatric Disorders
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.
Hatem AlAhmady, Professor study chair
Professor of maxillofacial surgery department azhar university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSI in people with Mandible Prognathism and Mandibular Retrognathism, run by Faculty of Dental Medicine for Girls 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 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 30 Oct 2025. 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?
Accuracy of PSI and bony segment movements (time frame: Baseline (preoperative), immediate postoperative, and 3-month postoperative follow-up.). 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 30 Oct 2025.