Loading clinical trials...
Loading clinical trials...
Evaluation of the Efficacy of Computer Guided Lag Screw Fixation in Comparison to Conventional Lag Screw Fixation in Anterior Mandibular Fractures (RCT)
Comparison between computer guided lag screw fixation versus traditional lag screw fixation in open reduction and internal fixation of anterior mandibular fractures.
Two groups of patients with anterior mandibular fractures indicated for open reduction and internal fixation. First group will be subjected to computer guided lag screw fixation. Second group will be subjected to traditional lag screw fixation. Eligible patients will be randomised in equal proportions between study group (computer guided lag screw fixation) and control group (conventional lag screw fixation). A- Computer guided lag screw fixation group: * Pre operative Computed tomography will be done for the patient. * Computed tomography data will be imported into Computer aided surgical simulation software. * Utilizing Computer aided surgical simulation software the fracture segments are virtually reduced and patient specific surgical guide is designed and sent to three dimension printer before operation. * Intra operative: All cases will undergo surgery under general anaesthesia. * Exposure of the fractured segments will be done using vestibular incision. * Inter-maxillary fixation will be done * The fractured segments will be reduced in normal anatomic position guided by occlusion. * Fracture fragments will be fixed using lag screws utilizing patient specific surgical guide. * Closure of the surgical incision. * Post operative at first week Computed tomography will be done for the patient. * Computed tomography data will be imported into computer aided surgical simulation software. * Utilizing computer aided surgical simulation software the post operative computed tomography will be superimposed onto the pre operative planned simulation. B- Conventional titanium plates: * Pre operative Computed tomography will be done for the patient. * Computed tomography data will be imported into Computer aided surgical simulation software. * Utilizing Computer aided surgical simulation software the fracture segments are virtually reduced. * Intra operative: All cases will undergo surgery under general anaesthesia. * Exposure of the fractured segments will be done using vestibular incision. * Inter-maxillary fixation will be done. * The fractured segments will be reduced in normal anatomic position guided by occlusion. * The fracture fragments will be fixed using lag screws. * Closure of the surgical incision. * Post operative at first week Computed tomography will be done for the patient. * Computed tomography data will be imported into computer aided surgical simulation software. * Utilizing computer aided surgical simulation software the post operative computed tomography will be superimposed onto the pre operative planned simulation. Follow up for both groups: Clinical evaluation will be performed at first week postoperative then patients will be recalled every week for one month. Final follow up visit will be at 3 months post operative.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Faculty of Oral and Dental Medicine - Cairo University
Giza, Egypt
Start Date
January 11, 2018
Primary Completion Date
March 1, 2019
Completion Date
June 1, 2019
Last Updated
May 21, 2018
26
ESTIMATED participants
Computer guided lag screw fixation
PROCEDURE
Conventional lag screw fixation
PROCEDURE
Lead Sponsor
Cairo University
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06895174