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

Cairo University20 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Mandible Fracture

Interventions

2.0 single locking miniplatesPROCEDURE

The fractured segments in the parasymphyseal region will be fixed using 2.0 single locking miniplates placed on the inferior border of the mandible.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Biting force

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

Time frame: 6 months

Secondary Outcomes

Stability of fractured segments

Bi-manual manipulation (Binary Yes/No)

Time frame: 6 weeks

Pain intensity

Visual analog scale (0-10) 0=No pain \& 10=Severe pain

Time frame: 10 days

Occlusion

Clinical examination (Intact/Deranged)

Time frame: 6 months

Infection

Clinical examination (Present/Absent)

Time frame: 6 months

Hardware failure

Clinical examination (Present/Absent)

Time frame: 6 months

Paraesthesia

Observation/Contact detection/Pin-brick nociception (0-10) 0=No sensation \& 10= Normal sensation

Time frame: 6 months

Wound dehiscence

Clinical examination (Present/Absent)

Time frame: 6 months

Data from ClinicalTrials.gov

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