Condylar Segment Repositioning Using CAD/CAM Generated Wafer After BSSO in Skeletal Mandibular Deformity

NCT ID: NCT03983265

Last Updated: 2019-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-20

Study Completion Date

2020-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Maintaining the condylar position after bilateral sagittal split ramus osteotomy (BSSO) is one of the most important aspects in terms of condylar function ,.An altered condylar position can cause internal derangement of the joint, loss of the mandibular angle, increased risk of relapse, condyle sagging, and impaired masticatory function.

In previous years, a great deal of attention has been paid to maintaining the preoperative condylar position during orthognathic surgery. Numerous condylar positioning methods have been reported and could be divided into manual/empirical methods, conventional methods , navigation, and sonographic monitoring, Computer guided methods which is more accurate than other methods

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

unpredictable condylar position after orthognathic surgery, will lead to malocclusion, derangement of the condylar surface, condylar resorption, condylar sag, distraction of the condyles from the fosse. In previous years, several authors had been adopted several techniques to maintain the preoperative condylar position during orthognathic surgery. Numerous condylar positioning methods have been reported which could be divided into conventional techniques (manual maneuvers or aiding tools), Extra and intra oral navigational techniques , surgeons had been utilized these techniques in condylar repositiong after BSSO but it was time and effort consuming and sometimes it was inaccurate. the aim for conducting the research is accurate positioning of condyle three dimensionally to minimize effort and operating time of surgery .

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Skeletal Abnormalities

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Condylar/Proximal Segments Repositioning Using CAD/CAM Generated Wafer After Bilateral Sagittal Split Osteotomy in Skeletal Mandibular Deformity
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

computer guided condylar reposition device

surgical procedure : under general anesthesia after BSSO condyle will be repositioned by computer guided repostioning device

Group Type OTHER

Bilateral Sagittal Split Osteotomy

Intervention Type OTHER

after BSSO condyle will be re positioned by using computer guided device

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bilateral Sagittal Split Osteotomy

after BSSO condyle will be re positioned by using computer guided device

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age of the patient above 18 years
* Patients needs bilateral sagittal split osteotomy
* All patients are free from any systemic disease that may affect normal bone healing
* Sufficient dentition to reproduce the occlusal relationships
* Patient's consent to participate

Exclusion Criteria

* Patient with TMJ Disorders
* Patients with any systemic disease that may affect normal healing
* Intra-bony lesions or infections that may interfere with surgery.the presence of
* Previous orthognathic surgeries
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

yara mamdouh mustafa

Teaching Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mohammed omara, Lecturer

Role: STUDY_DIRECTOR

faculty of oral and dental medicine Cairo university

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

oral and dental medicine Cairo university

Giza, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

yara mamdouh mustafa, BDS

Role: CONTACT

01002955632

yara mamdouh mustafa, BDS

Role: CONTACT

0100295532

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

yara mamdouh, BDS

Role: primary

01002955632

Mohammed omara, PHD

Role: backup

01144452862

Related Links

Access external resources that provide additional context or updates about the study.

https://www.ncbi.nlm.nih.gov/pubmed/22668627

Computer-assisted orthognathic surgery: feasibility study using multiple CAD/CAM surgical splints

https://www.ncbi.nlm.nih.gov/pubmed/23312847

Orthognathic Positioning System: Intraoperative System to Transfer Virtual Surgical Plan to Operating Field During Orthognathic Surgery

https://www.ncbi.nlm.nih.gov/pubmed/24099655

Clinical and radiographic evaluation of a computer-generated guiding device in bilateral sagittal split osteotomies

https://www.ncbi.nlm.nih.gov/pubmed/26258114

A novel method for the management of proximal segment using computer assisted simulation surgery: correct condyle head positioning and better proximal segment placement

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ymmustafa

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mandibular Reconstruction Bone Plate
NCT06099431 ENROLLING_BY_INVITATION NA