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

This study has been completed.
Sponsor:
Collaborators:
Faculty of dentistry,Dhamar university,Yemen
faculty of oral and dental medicine,Cairo,Egypt
Information provided by (Responsible Party):
ESSAM ALMORAISSI, Cairo University
ClinicalTrials.gov Identifier:
NCT01939015
First received: August 22, 2013
Last updated: December 27, 2013
Last verified: December 2013
  Purpose
  • 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.


Condition Intervention
Displaced Mandibular Angle Fracture
Device: 3D titanium miniplate
Device: Standard titanium miniplate- single non compression miniplate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 3D Vs Standard Miniplate in Fixation of the MAFs

Resource links provided by NLM:


Further study details as provided by Cairo University:

Primary Outcome Measures:
  • postoperative complications [ Time Frame: 6 monuths ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Radiographic follow-up [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The patients will be examined radiographically for accuracy of the reduction, screw positioning, adverse reactions in the vicinity of screw placement, and bone healing by using digora software.


Other Outcome Measures:
  • mouth opening [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    BY USING BOELY GAUGE IN MILLIMTER


Estimated Enrollment: 20
Study Start Date: February 2013
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard titanium miniplate- single non compression miniplate
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
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
Other Name: Universal Mandible System, Stryker-Lei binger, Freiburg, Germany
Device: Standard titanium miniplate- single non compression miniplate
single non compression miniplate placed at superior border with monocortical screws via intraoral approach
Other Name: Champy technique (single non compression miniplate)
Experimental: three dimensional titanium miniplate
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
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
Other Name: Universal Mandible System, Stryker-Lei binger, Freiburg, Germany
Device: Standard titanium miniplate- single non compression miniplate
single non compression miniplate placed at superior border with monocortical screws via intraoral approach
Other Name: Champy technique (single non compression miniplate)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   17 Years to 45 Years
Genders Eligible for Study:   Both
Criteria
  • Inclusion Criteria:

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

    • infected angle mandibular fracture
    • atrophied mandibular fracture
    • angle fracture with subcondylar fracture
    • patients under 17 year
    • gun shout injury associated fracture
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01939015

Locations
Egypt
Department of Oral and Maxillofacial SurgeryFaculty of Oral and Dental Medicine
Cairo, Giza, Egypt, 17445
Sponsors and Collaborators
Cairo University
Faculty of dentistry,Dhamar university,Yemen
faculty of oral and dental medicine,Cairo,Egypt
  More Information

No publications provided

Responsible Party: ESSAM ALMORAISSI, lecturer in Faculty of Dentistry,Dhamar University,Yemen, Cairo University
ClinicalTrials.gov Identifier: NCT01939015     History of Changes
Other Study ID Numbers: 201301, OMFS201301
Study First Received: August 22, 2013
Last Updated: December 27, 2013
Health Authority: Egypt : Faculty of Oral and Dental Medicine

Keywords provided by Cairo University:
3D miniplate
angle mandibular fracture
champy technique
internal rigid fixation

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on July 20, 2014