Three Dimensional Versus Standard Miniplate In Fixation Of Mandibular Angle Fracture- A Prospective Randomized Controlled Clinical Trial

NCT01939015 | Completed

• 2 other identifiers: 201301OMFS201301
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

• The aim of this study is to compare the standard and 3D miniplates fixation in mandibular angle fractures regarding to wound dehiscence, infection, nonunion, pain, hypoesthesia, and malocclusion. and to analyze advantages and disadvantages of one method over the other.
• Radiographic follow-up (in the form of posteroanterior and panoramic radiographs) will used to evaluate the patients immediately and 2 and 4 months postoperatively. Patients returned 7 days after surgery for clinical evaluation . The patients will be examined radiographically for accuracy of the reduction, screw positioning, adverse reactions in the vicinity of screw placement, and bone healing. the complications encountered will be recorded and treated. The clinical evaluations will be performed by 1 surgeon at each institution.
• The patients will also evaluated clinically for infection, nonunion, pain, hypoesthesia, and malocclusion. Malocclusion will assessed based on patient complaints. Criteria for infection will based on either of the following conditions: 1) purulent discharge from an incision and 2) serosanguineous drainage and a wound culture positive for a known pathogen. All the patients will evaluated postoperatively by a single assessor.
• Statically analysis : Student's t test will be used to compare 3D and Champy's miniplate fixation. A value of P ≤ 0.05 will be considered statistically significant.

Conditions

Displaced Mandibular Angle Fracture

Keywords

3D miniplate; angle mandibular fracture; champy technique; internal rigid fixation

Outcome Measures

Primary Outcomes (1)

• postoperative complications

  1. Wound dehiscence (binary outcome) by Clinical examination 2. mal /un union (binary outcome) by Clinical examination 3. Evaluation of Occlusion (binary outcome) (Only after 3 months of fracture treatment) by using the treatment scoring system35 Surgeon's evaluation * 5 points: occlusion altered bilaterally. Reoperation required. * 3 points: occlusion altered on one side: Reoperation required * 1 point: occlusion altered on one side. The other side has to be adjusted. * 3 points: occlusion adequate on both sides but not the same as before injury. * 5 points: occlusion the same as before injury.

  6 monuths

Secondary Outcomes (1)

• Radiographic follow-up

  6 months

Other Outcomes (1)

• mouth opening

  7 days

Study Arms (2)

Standard titanium miniplate- single non compression miniplate

ACTIVE COMPARATOR

fixation will be perform by A single non compression miniplate with 4-hole 2-mm using 2-mm monocortical screws at superior border of the mandible according to ideal lines of osteosynthesis.

Device: 3D titanium miniplate; Device: Standard titanium miniplate- single non compression miniplate

three dimensional titanium miniplate

EXPERIMENTAL

3D curved strut miniplate\* (Universal Mandible System, Stryker-Lei binger, Freiburg, Germany) , installed and stabilized with monocortical screws. The 3D plate will be place in such a way that a horizontal bar is perpendicular and a vertical bar is parallel to the fracture line.

Device: 3D titanium miniplate; Device: Standard titanium miniplate- single non compression miniplate

Interventions

3D titanium miniplate DEVICE

for study group by using 3D titanium miniplate under open reduction under general anesthesia with mono cortical screw, while in control group single titanium miniplate at superior border with mono cortical screw according to ideal line of osteosynthesis of champy

Also known as: Universal Mandible System, Stryker-Lei binger, Freiburg, Germany

Standard titanium miniplate- single non compression miniplate; three dimensional titanium miniplate

Standard titanium miniplate- single non compression miniplate DEVICE

single non compression miniplate placed at superior border with monocortical screws via intraoral approach

Also known as: Champy technique (single non compression miniplate)

Standard titanium miniplate- single non compression miniplate; three dimensional titanium miniplate

Eligibility Criteria

• Age: 17 Years - 45 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adults dentate patients (\>17 years old) with displaced an angle mandibular fracture
• non infected non comminuted angle mandibular fracture

You may not qualify if:

• infected angle mandibular fracture
• atrophied mandibular fracture
• angle fracture with subcondylar fracture
• patients under 17 year
• gun shout injury associated fracture

Sponsors & Collaborators

• Cairo University: lead
• Thamar University: collaborator

Study Sites (1)

Department of Oral and Maxillofacial SurgeryFaculty of Oral and Dental Medicine

Cairo, Giza Governorate, 17445, Egypt

Location

Related Publications (1)

• Al-Moraissi EA, Mounair RM, El-Sharkawy TM, El-Ghareeb TI. Comparison between three-dimensional and standard miniplates in the management of mandibular angle fractures: a prospective, randomized, double-blind, controlled clinical study. Int J Oral Maxillofac Surg. 2015 Mar;44(3):316-21. doi: 10.1016/j.ijom.2014.10.012. Epub 2014 Nov 15.

  PMID: 25457871 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer in Faculty of Dentistry,Dhamar University,Yemen

Study Record Dates

• First Submitted: August 22, 2013
• First Posted: September 11, 2013
• Study Start: February 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 30, 2013

Record last verified: 2013-12

Locations

EG (1)