Clinical Trials Directory

Trials / Unknown

UnknownNCT05444829

Specific Screw Holes Locating Surgical Guide and Pre-bent Plates

Precision of Patient Specific Screw Holes Locating Surgical Guide and Pre-bent Plates Osteosynthesis Versus Classical Work-flow in Management of Class III Mandibular Fractures

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
26 (estimated)
Sponsor
Abdallah Gaber Ali Mohamed · Academic / Other
Sex
All
Age
Healthy volunteers
Accepted

Summary

The aim of the current study was to evaluate the accuracy of computer-guided mandibular fracture reduction versus the classical work flow

Detailed description

Research question: Does the use of screw holes locating surgical guide \& pre-bent plates osteosynthesis accurately reduce class III mandibular fractures regarding segments integrity and occlusion more than the classical reduction and fixation? Statement of the problem: Mandibular fractures are the most frequently occurring fractures within the maxillofacial injuries. The evaluation, diagnosis, and management of these fractures remain challenging despite improved imaging technology and fixation techniques. Depending on the type and location of the fractures, various open and closed surgical reduction techniques can be utilized. There are several critical and inherent limitations to the current ,standard approach of mandibular fracture reduction and fixation includes : (improper alignment of segments ,malocclusion ,nerve affections and related teeth roots injury). There is a possibility to overcome these limitations with the help of computer-guided surgery . The introduction of CAD/CAM software has provided surgeons with an opportunity to perform virtual manipulations of CT datasets preoperatively and production of corrected mandibular model for plate pre-bending and fabrication of plate locating surgical guide which provide accurate segment reduction and fixation with accurate post-operative occlusion and minimal post-operative complication . The aim of the current study was to evaluate the accuracy of computer-guided mandibular fracture reduction versus the conventional work flow Rationale for conducting the research: Through computer guided mandibular fracture reduction investigators can provide proper segment alignment with subsequent accurate post-operative occlusion in addition reduce intra-operative time , post-operative pain and edema

Conditions

Interventions

TypeNameDescription
DEVICEspecific screw holes locating surgical guide and pre-bent platesPut the specific screw holes locating device in place and drill the screw holes, remove the screw holes locating device and mobilize the segments then apply the pre-bent plates and fix it with screw for passive reduction of the segments. Then suture the mentalis muscle then the mucosa.
DEVICEclassical reduction and internal fixation.mobilize the broken segment first, Arch bar was made to achieve proper occlusion put the compression plate on the inferior border and remove it for further bending using plate pliers for further accommodation of the plate on the inferior border the fix it in place using compression and tension plate.

Timeline

Start date
2022-07-01
Primary completion
2023-07-01
Completion
2023-09-01
First posted
2022-07-06
Last updated
2022-07-06

Source: ClinicalTrials.gov record NCT05444829. Inclusion in this directory is not an endorsement.