Stability of Angle Fracture Fixation With (K) Shaped Titanium Miniplates Versus Two Miniplates

NCT03839368 | Unknown

• 1 other identifier: CEBD-CU-2019-02-03
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

In patients with angle fracture , will the (K) shaped titanium miniplates provide more stable fixation than two conventional miniplates? Many studies have been conducted to compare between different techniques of fixation used in angle fracture fixation. The driving force behind this study was to design a new plate that would overcome the disadvantages of the other plating techniques but has the advantages \& simplicity of the Champy technique (simple intraoral approach and few major complications). This new miniplate gives more biomechanical stability than the conventional Champy plate. More over the placement of a 3D miniplate or two separate miniplates for fixing angle fractures is more difficult and mostly will require a transbuccal approach , with increased surgical trauma, longer operation time unlike the new plate that could provide the clinician with a simple and reliable solution.

Conditions

Mandible Fracture

Keywords

angle fracture

Outcome Measures

Primary Outcomes (1)

• Stability of angle fracture fixation

  Inter-ramus distance (fixed position at the lingual), inter-mental distance will be obtained from the immediate postoperative facial bone CT \& after 3 months. Comparison between the 2 records will be done to assess the stability of fixation technique. Bone density will be measured by Hounsfield unit at fracture site immediate postoperative \& after 3 months using F.B.CT.

  3 months

Study Arms (2)

K plate

EXPERIMENTAL

fixation of angle fracture using K plate versus two miniplates

Procedure: fixation of angle fracture

Conventional two miniplates

ACTIVE COMPARATOR

fixation of angle fracture using K plate versus two miniplates

Procedure: fixation of angle fracture

Interventions

fixation of angle fracture PROCEDURE

open reduction and internal fixation of angle fracture

Conventional two miniplates; K plate

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with unilateral angle fracture.
• Patients free from any systemic disease \& bone metabolism diseases.
• No sex predilection
• Age range ( 15-70)

You may not qualify if:

• Comminuted fragmented \& infected angle fractures.
• Bilateral angle fracture.
• Systemic diseases.
• bone metabolism diseases

Sponsors & Collaborators

• Cairo University: lead

Related Publications (2)

• Suer BT, Kocyigit ID, Kaman S, Tuz HH, Tekin U, Atil F. Biomechanical evaluation of a new design titanium miniplate for the treatment of mandibular angle fractures. Int J Oral Maxillofac Surg. 2014 Jul;43(7):841-5. doi: 10.1016/j.ijom.2014.01.011. Epub 2014 Feb 24.

  PMID: 24582290 BACKGROUND

• El-Sherif HM, Ali S, Talaat M, Mubarak F. Stability and Clinical Outcomes of Angle Fracture Fixation Using Sagittal Split Plate (SSOP) Versus Two Miniplates: Randomized Clinical Trial. J Maxillofac Oral Surg. 2024 Feb;23(1):107-113. doi: 10.1007/s12663-022-01817-z. Epub 2022 Nov 16.

  PMID: 38312972 DERIVED

MeSH Terms

Conditions

Mandibular Fractures

Condition Hierarchy (Ancestors)

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

Study Officials

• Hagar Mohamed, BDS

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hagar A Mohamed, BDS

CONTACT

01016799911; hagar_elsherif92@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Cards will have sequential numbers one number for each card then these cards will be placed within opaque sealed envelopes. Then these envelops will be placed in a container (box), each participant will grasp one envelope the day of procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Oral and Maxillofacial Surgery - Nasser Institute Hospital for research & treatment / Master Candidate of Oral & Maxillofacial surgery, Cairo University

Model Details: Randomized

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 15, 2019
• Study Start: April 1, 2020
• Primary Completion: April 11, 2020
• Study Completion: April 1, 2021
• Last Updated: June 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share