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

Not Applicable

• Conditions: Mandible Fracture
• Interventions: Procedure: 2.0 single locking miniplates

• Registration Number: NCT03747666
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2018-11-12
• Study First Submitted QC: 2018-11-18
• Study First Posted: 2018-11-20
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-18
• Last Update Posted: 2019-02-19
• Study Start: 2019-11
• Primary Completion: 2019-11
• Study Completion: 2020-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Locking miniplate	2.0 single locking miniplates	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.
Non-locking miniplates	2.0 single 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.

Primary Outcome Measures

Name	Time	Method
Biting force	6 months	Biting force will be measured using occlusal biting force meter (Higher biting force record is better)

Secondary Outcome Measures

Name	Time	Method
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
Paraesthesia	6 months	Observation/Contact detection/Pin-brick nociception (0-10) 0=No sensation \& 10= Normal sensation
Hardware failure	6 months	Clinical examination (Present/Absent)
Wound dehiscence	6 months	Clinical examination (Present/Absent)
Occlusion	6 months	Clinical examination (Intact/Deranged)
Infection	6 months	Clinical examination (Present/Absent)