Evaluation of the Accuracy of Patient Specific Implant in... | NCT07222904

Studies
Evaluation of the Accuracy of Patient Specific Implant in Fixation of Mandibular Sagittal Split Osteotomy

NCT07222904

Sponsor

Faculty of Dental Medicine for Girls

Status

Completed

Last Update Posted

Oct 30, 2025Actual

Enrollment

8Actual

Phase

Not Applicable

Conditions

Mandible Prognathism
Mandibular Retrognathism

Interventions

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2023Actual

Primary Completion Date

Apr 15, 2025Actual

Completion Date

May 20, 2025Actual

First Submitted Date

Oct 27, 2025

First Submission Date that Met QC Criteria

Oct 29, 2025

First Posted Date

Oct 30, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 29, 2025

Last Update Posted Date

Oct 30, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eman Ashour, Assistant Lecturer at Oral and Maxillofacial Surgery department at AlAzhar University, Faculty of Dental Medicine for GirlsPrincipal Investigator

Lead Sponsor

Faculty of Dental Medicine for GirlsOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BSSO using PSI	Experimental	8 Patients underwent bilateral sagittal split Osteotomy fixed with patient' specific implants	Device: PSI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PSI	Device	orthognathic surgery BSSO using PSI	BSSO using PSI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	Baseline (preoperative), immediate postoperative, and 3-month postoperative follow-up.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hatem AlAhmady, Professor	Professor of maxillofacial surgery department azhar university	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eman Ashour		Cairo		12345	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008313	Malocclusion, Angle Class III

Ancestor Terms

ID	Term
D008310	Malocclusion
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided