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

February 18, 2019 updated by: Hany Abdelkader Hussein, Cairo University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biting force
Time Frame: 6 months
Biting force will be measured using occlusal biting force meter (Higher biting force record is better)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stability of fractured segments
Time Frame: 6 weeks
Bi-manual manipulation (Binary Yes/No)
6 weeks
Pain intensity
Time Frame: 10 days
Visual analog scale (0-10) 0=No pain & 10=Severe pain
10 days
Occlusion
Time Frame: 6 months
Clinical examination (Intact/Deranged)
6 months
Infection
Time Frame: 6 months
Clinical examination (Present/Absent)
6 months
Hardware failure
Time Frame: 6 months
Clinical examination (Present/Absent)
6 months
Paraesthesia
Time Frame: 6 months
Observation/Contact detection/Pin-brick nociception (0-10) 0=No sensation & 10= Normal sensation
6 months
Wound dehiscence
Time Frame: 6 months
Clinical examination (Present/Absent)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2019

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

November 1, 2020

Study Registration Dates

First Submitted

November 12, 2018

First Submitted That Met QC Criteria

November 18, 2018

First Posted (Actual)

November 20, 2018

Study Record Updates

Last Update Posted (Actual)

February 19, 2019

Last Update Submitted That Met QC Criteria

February 18, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30101980

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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