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

Primary Purpose

Mandible Fracture

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
2.0 single locking miniplates
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mandible Fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Locking miniplate

    Non-locking miniplates

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Biting force
    Biting force will be measured using occlusal biting force meter (Higher biting force record is better)

    Secondary Outcome Measures

    Stability of fractured segments
    Bi-manual manipulation (Binary Yes/No)
    Pain intensity
    Visual analog scale (0-10) 0=No pain & 10=Severe pain
    Occlusion
    Clinical examination (Intact/Deranged)
    Infection
    Clinical examination (Present/Absent)
    Hardware failure
    Clinical examination (Present/Absent)
    Paraesthesia
    Observation/Contact detection/Pin-brick nociception (0-10) 0=No sensation & 10= Normal sensation
    Wound dehiscence
    Clinical examination (Present/Absent)

    Full Information

    First Posted
    November 12, 2018
    Last Updated
    February 18, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03747666
    Brief Title
    Single Locking Miniplate and Two Non-locking Miniplates in the Management of Parasymphyseal Fracture
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2019 (Anticipated)
    Primary Completion Date
    November 2019 (Anticipated)
    Study Completion Date
    November 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mandible Fracture

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Locking miniplate
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Non-locking miniplates
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    2.0 single locking miniplates
    Intervention Description
    The fractured segments in the parasymphyseal region will be fixed using 2.0 single locking miniplates placed on the inferior border of the mandible.
    Primary Outcome Measure Information:
    Title
    Biting force
    Description
    Biting force will be measured using occlusal biting force meter (Higher biting force record is better)
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Stability of fractured segments
    Description
    Bi-manual manipulation (Binary Yes/No)
    Time Frame
    6 weeks
    Title
    Pain intensity
    Description
    Visual analog scale (0-10) 0=No pain & 10=Severe pain
    Time Frame
    10 days
    Title
    Occlusion
    Description
    Clinical examination (Intact/Deranged)
    Time Frame
    6 months
    Title
    Infection
    Description
    Clinical examination (Present/Absent)
    Time Frame
    6 months
    Title
    Hardware failure
    Description
    Clinical examination (Present/Absent)
    Time Frame
    6 months
    Title
    Paraesthesia
    Description
    Observation/Contact detection/Pin-brick nociception (0-10) 0=No sensation & 10= Normal sensation
    Time Frame
    6 months
    Title
    Wound dehiscence
    Description
    Clinical examination (Present/Absent)
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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