Specific Screw Holes Locating Surgical Guide and Pre-bent Plates

NCT05444829 | Unknown

• 1 other identifier: class III mandibular fractures
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Mandibular Fractures

Keywords

class III

Outcome Measures

Primary Outcomes (1)

• computer tomography

  the Computer Tomography Will calculate the segments deviation in mm. after 3 month .

  after 3 months

Study Arms (2)

specific screw holes locating surgical guide and pre-bent plates

EXPERIMENTAL

Put 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.

Device: specific screw holes locating surgical guide and pre-bent plates

classical reduction and fixation

OTHER

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.

Device: classical reduction and internal fixation.

Interventions

specific screw holes locating surgical guide and pre-bent plates DEVICE

Put 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.

specific screw holes locating surgical guide and pre-bent plates

classical reduction and internal fixation. DEVICE

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.

classical reduction and fixation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abdallah Gaber Ali Mohamed: lead

Related Publications (1)

• Gaber A, Hatem H, El M, Omara M. Precision of patient specific screw holes locating surgical guide and pre-bent plates osteosynthesis versus classical workflow in management of class III mandibular fracture. Maxillofac Plast Reconstr Surg. 2025 Dec 19;47(1):43. doi: 10.1186/s40902-025-00495-4.

  PMID: 41417183 DERIVED

Related Links

• Reginald H.B. Goodday/Management of Fractures of the Mandibular Body and Symphysis. Oral Maxillofacial Surg Clin North Am. 2013 Nov;25
• Evaluation of the Accuracy of Computer-Guided Mandibular Fracture Reduction. 2015 Jul;26(5):1587-91.doi: 10.1097/SCS.0000000000001773.
• Parul Sinha , Gary Skolnick , Kamlesh B Patel , Gregory H Branham , John J Chi /A 3-Dimensional-Printed Short-Segment Template Prototype for Mandibular Fracture Repair. 2018 Sep 1;20(5):373-380
• Comparison of 3D plate and locking plate in treatment of mandibular fracture-a clinical study. Oral Maxillofacial Surg 2017 Dec;21(4)
• Scott Lovald , Bret Baack, Curtis Gaball, Garth Olson, Anna 31 Hoard/Biomechanical optimization of bone plates used in rigid fixation of mandibular symphysis fractures. 2010 Aug

MeSH Terms

Conditions

Mandibular Fractures

Interventions

Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Mohammed Omara

  Cairo University

  STUDY DIRECTOR

• mona el hadidy

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

abdallah gaber

CONTACT

01155778958; abdallahgaber@dentistry.cu.edu.eg

Hussein Hatem

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: July 6, 2022
• Study Start: July 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: September 1, 2023
• Last Updated: July 6, 2022

Record last verified: 2022-07