Computer Guided Lag Screw Fixation Versus Conventional Lag Screw Fixation in Anterior Mandibular Fractures
NCT ID: NCT03530891
Last Updated: 2018-05-21
Study Results
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.
UNKNOWN
NA
26 participants
INTERVENTIONAL
2018-01-11
2019-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Specific Screw Holes Locating Surgical Guide and Pre-bent Plates
NCT05444829
Accuracy of Computer Guided Screw Holes Locating Guide and Patient Specific Champy Plate vs Conventional Champy Plate Osteosynthesis in Management of Mandibular Angle Fracture: Randomized Controlled Trial
NCT06838377
Comparative Study Evaluating Stability of Fracture Segments After Treatment of Mandibular Angle Fracture With 3d Strut Plate With or Without IMMF.
NCT03640039
Patient Satisfaction Vertical Ramus Osteotomy Patient Specificosteosynthesis Fixation Versus MMFmandibular Prognanthism
NCT03855072
Single Locking Miniplates Versus Double Non-Locking Miniplates in Anterior Mandibular Fracture
NCT06938438
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
* Parallel group study.
* A trial will be carried out in hospital of Oral and Maxillofacial surgery department- Faculty of Oral and Dental Medicine Cairo University
* Equal randomization: participants with equal probabilities for intervention.
* Positive controlled: Both groups receiving treatment.
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Computer guided lag screw fixation
Patient specific surgical guided will be used for open reduction and internal fixation for anterior mandibular fracture by lag screws.
Computer guided lag screw fixation
Under general anaesthesia: Patient specific pre operative prefabricated surgical guide will be used intra operative for open reduction and internal fixation for anterior mandibular fracture using lag screws.
Conventional lag screw fixation
Open reduction and internal fixation for anterior mandibular fracture using lag screws.
Conventional lag screw fixation
Under general anaesthesia: Open reduction and internal fixation for anterior mandibular fracture utilising lag screws.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Computer guided lag screw fixation
Under general anaesthesia: Patient specific pre operative prefabricated surgical guide will be used intra operative for open reduction and internal fixation for anterior mandibular fracture using lag screws.
Conventional lag screw fixation
Under general anaesthesia: Open reduction and internal fixation for anterior mandibular fracture utilising lag screws.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* All ages and both sexes were included in this study.
* Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
* Patients with good general condition allowing major surgical procedure under general anaesthesia .
* Patients with physical and psychological tolerance.
Exclusion Criteria
* Patients with high risk systemic diseases like uncontrolled diabetes mellitus. As uncontrolled diabetes mellitus has a negative impact on normal bone healing.
* Patients with old and/or mal-union fractures. As they will affect accuracy of reduction of the fractured segments.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cairo University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mohamed Kadry
Assistant lecturer
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Khaled S Amr, PhD
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.
Faculty of Oral and Dental Medicine - Cairo University
Giza, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Ellis E 3rd, Ghali GE. Lag screw fixation of anterior mandibular fractures. J Oral Maxillofac Surg. 1991 Jan;49(1):13-21; discussion 21-2. doi: 10.1016/0278-2391(91)90259-o.
Ellis E 3rd. Is lag screw fixation superior to plate fixation to treat fractures of the mandibular symphysis? J Oral Maxillofac Surg. 2012 Apr;70(4):875-82. doi: 10.1016/j.joms.2011.08.042. Epub 2011 Dec 30.
Kallela I, Ilzuka T, Laine P, Lindqvist C. Lag-screw fixation of mandibular parasymphyseal and angle fractures. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1996 Nov;82(5):510-6. doi: 10.1016/s1079-2104(96)80195-8.
Xia JJ, Gateno J, Teichgraeber JF, Christensen AM, Lasky RE, Lemoine JJ, Liebschner MA. Accuracy of the computer-aided surgical simulation (CASS) system in the treatment of patients with complex craniomaxillofacial deformity: A pilot study. J Oral Maxillofac Surg. 2007 Feb;65(2):248-54. doi: 10.1016/j.joms.2006.10.005.
Zachariades N, Mezitis M, Papademetriou I. Use of lag screws for the management of mandibular trauma. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1996 Feb;81(2):164-7. doi: 10.1016/s1079-2104(96)80407-0.
Tiwana PS, Kushner GM, Alpert B. Lag screw fixation of anterior mandibular fractures: a retrospective analysis of intraoperative and postoperative complications. J Oral Maxillofac Surg. 2007 Jun;65(6):1180-5. doi: 10.1016/j.joms.2006.11.046.
Jones JK, Van Sickels JE. Rigid fixation: a review of concepts and treatment of fractures. Oral Surg Oral Med Oral Pathol. 1988 Jan;65(1):13-8. doi: 10.1016/0030-4220(88)90183-1.
Retzepi M, Donos N. The effect of diabetes mellitus on osseous healing. Clin Oral Implants Res. 2010 Jul;21(7):673-81. doi: 10.1111/j.1600-0501.2010.01923.x. Epub 2010 May 3.
Parashar A, Sharma RK. Unfavourable outcomes in maxillofacial injuries: How to avoid and manage. Indian J Plast Surg. 2013 May;46(2):221-34. doi: 10.4103/0970-0358.118597.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CEBD-CU-2018-5-4
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.