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Single Locking Miniplate and Two Non-locking Miniplates in the Management of Parasymphyseal Fracture

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ClinicalTrials.gov Identifier: NCT03747666
Recruitment Status : Unknown
Verified February 2019 by Hany Abdelkader Hussein, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : November 20, 2018
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Hany Abdelkader Hussein, Cairo University

Study Description
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Brief Summary:
Evaluating the biting force after management of parasymphyseal fracture in patients with two-line mandibular fractures.

Condition or disease Intervention/treatment Phase
Mandible Fracture Procedure: 2.0 single locking miniplates Not Applicable

Detailed Description:
Evaluating the biting force after using 2.0 mm single locking miniplate versus 2.0 mm two conventional non-locking miniplates in the management of parasymphyseal fracture in patients with two-line mandibular fractures.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating Masticatory Biting Force After Using Single Locking Miniplate Versus Two Non-locking Miniplates in the Management of Parasymphyseal Fracture in Patients With Two-line Mandibular Fractures
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arms and Interventions
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Arm Intervention/treatment
Experimental: Locking miniplate
The fractured segments in the parasymphyseal region will be fixed using 2.0 single locking miniplates and the fractured segments of the angle will be fixed conventionally using 2.0 single non-locking miniplate placed on the external oblique ridge.
 Procedure: 2.0 single locking miniplates
The fractured segments in the parasymphyseal region will be fixed using 2.0 single locking miniplates placed on the inferior border of the mandible.
Experimental: Non-locking miniplates
The fractured segments in the parasymphyseal region will be fixed using 2.0 two non-locking miniplates and the fractured segments of the angle will be fixed conventionally using 2.0 single non-locking miniplate placed on the external oblique ridge.
 Procedure: 2.0 single locking miniplates
The fractured segments in the parasymphyseal region will be fixed using 2.0 single locking miniplates placed on the inferior border of the mandible.


Outcome Measures
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Primary Outcome Measures :
  1. Biting force [ Time Frame: 6 months ]
    Biting force will be measured using occlusal biting force meter (Higher biting force record is better)


Secondary Outcome Measures :
  1. Stability of fractured segments [ Time Frame: 6 weeks ]
    Bi-manual manipulation (Binary Yes/No)

  2. Pain intensity [ Time Frame: 10 days ]
    Visual analog scale (0-10) 0=No pain & 10=Severe pain

  3. Occlusion [ Time Frame: 6 months ]
    Clinical examination (Intact/Deranged)

  4. Infection [ Time Frame: 6 months ]
    Clinical examination (Present/Absent)

  5. Hardware failure [ Time Frame: 6 months ]
    Clinical examination (Present/Absent)

  6. Paraesthesia [ Time Frame: 6 months ]
    Observation/Contact detection/Pin-brick nociception (0-10) 0=No sensation & 10= Normal sensation

  7. Wound dehiscence [ Time Frame: 6 months ]
    Clinical examination (Present/Absent)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Contra-lateral unfavorable non-comminuted simple or compound mandibular fracture in the parasymphyseal and angle regions.
  • Fractures amenable to treatment using intra oral approach.

Exclusion Criteria:

  • Medically compromised patients who are unfit for the procedure under general anesthesia.
  • Patients with comminuted fractures.
  • Patients with history of occlusion disturbances or skeletal malocclusion.
  • Patients with insufficient dentition to reproduce occlusion.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Hany Abdelkader Hussein, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03747666    
Other Study ID Numbers: 30101980
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mandibular Fractures
Fractures, Bone
Wounds and Injuries
Jaw Fractures
Maxillofacial Injuries
 Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Skull Fractures