An interventional study of PSI in Mandible Prognathism and Mandibular Retrognathism, sponsored by Faculty of Dental Medicine for Girls. Completed at 1 site in Egypt. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-10-30.
Sponsored by Faculty of Dental Medicine for Girls · Not applicable, Interventional, and Treatment
Study was Conducted on Patients were need BSSO Using PSI for reposition and fixation
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.
57 studies on the registry are indexed under Malocclusion, Angle Class III; 11 are open to participants now.
This study's enrollment of 8 is below the median of 32 across 53 interventional studies indexed under Malocclusion, Angle Class III.
Browse Malocclusion, Angle Class III studies →Faculty of Dental Medicine for Girls is the lead sponsor of 54 studies on the registry; 6 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
8 Patients underwent bilateral sagittal split Osteotomy fixed with patient' specific implants
Device: PSI
orthognathic surgery BSSO using PSI
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
Time frame: Baseline (preoperative), immediate postoperative, and 3-month postoperative follow-up.
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2023 to primary completion in Apr 2025, 27 months.
Of 37 non-industry interventional studies with no phase under Malocclusion, Angle Class III, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 26. This study's 27 months is above that.
Counting every sponsor, half of 38 studies reached it within 13 months; a quarter within 10 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Malocclusion, Angle Class III →
Faculty of Dental Medicine for Girls