Clinical trial NCT05444829: Specific Screw Holes Locating Surgical Guide and Pre-bent Plates
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mandibular Fractures
Keywords: class III
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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

Eligibility criteria: Inclusion Criteria:

* Patients with delayed and isolated mandibular class III fracture needs open reduction and internal fixation.
* Patients with medical history that did not hinder plate placement (uncontrolled diabetes) and adequate proper oral hygiene.
* Both genders males and females will be included.

Exclusion Criteria:

* • General contraindications to surgery.

  * Patients with fresh fractures (mobile segments).
  * Patients with unfavourable nor comminuted fractures.
  * Subjected to irradiation in the head and neck area less than 1 year before fixation.
  * Untreated periodontitis.
  * Poor oral hygiene and motivation.
  * Uncontrolled diabetes.
  * Pregnant or nursing.
  * Substance abuse.
  * Psychiatric problems or unrealistic expectations.
  * Severe bruxism or clenching.
  * Immunosuppressed or immunocompromised.
  * Treated or under treatment with intravenous amino-bisphosphonates.
  * Patients participating in other studies, if the present protocol could not be properly followed.

Primary outcomes:
measure: computer tomography
timeFrame: after 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Mohammed Omara
role: STUDY_DIRECTOR
affiliation: Cairo University
name: mona el hadidy
role: STUDY_DIRECTOR
References: