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

Sponsor

Cairo University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03747666

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Nov 1, 2019

Anticipated Primary Completion Date :

Nov 1, 2019

Anticipated Study Completion Date :

Nov 1, 2020

Arms and Interventions

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.

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

Primary Outcome Measures

Biting force [6 months]
Biting force will be measured using occlusal biting force meter (Higher biting force record is better)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hany Abdelkader Hussein, Principal Investigator, Cairo University

ClinicalTrials.gov Identifier:

NCT03747666

Other Study ID Numbers:

30101980

First Posted:

Nov 20, 2018

Last Update Posted:

Feb 19, 2019

Last Verified:

Feb 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Mandibular Fractures

Fractures, Bone

Study Results

No Results Posted as of Feb 19, 2019