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InterFlex Plate Versus Conventional Miniplates in the Management of Anterior Mandibular Fractures.

NCT ID: NCT06740292

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-25

Study Completion Date

2024-12-01

Brief Summary

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the study aims to compare InterFlex plate with conventional miniplates in management of symphyseal mandibular fracture clinically regarding pain, wound healing and postoperative occlusion, and radiographically regrading bone density.

Detailed Description

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A total of 18 patients with recent symphyseal mandibular fractures were allocated into two groups. Group A, comprising 9 patients, underwent treatment with the InterFlex plate, while Group B, also consisting of 9 patients, was treated with conventional two miniplates. Clinical evaluations were carried at multiple intervals up to 12 weeks postoperatively, with radiographic assessments performed immediately after surgery and at 12 weeks to measure mean bone density at the fracture line.

Conditions

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Anterior Mandibular Fracture

Keywords

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anterior mandibular fracture symphyseal fracture para-symphyseal fracture InterFlex plate functionally stabilized fixation miniplate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
Patients were allocated in a 1:1 ratio using an on-site computer software system with concealed allocation through sequentially numbered, opaque, sealed envelopes (SNOSE). Group A was treated with InterFlex plates, and Group B with conventional miniplates

Study Groups

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Patients with anterior mandibular fracture managed with conventional miniplates

Patients with anterior mandibular fracture managed with conventional miniplates

Group Type ACTIVE_COMPARATOR

conventional miniplates

Intervention Type DEVICE

conventional miniplates in double configuration

Patients with anterior mandibular fracture managed with InterFlex plates

Patients with anterior mandibular fracture managed with InterFlex plates

Group Type EXPERIMENTAL

InterFlex plates

Intervention Type DEVICE

InterFlex plates in configuration

Interventions

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conventional miniplates

conventional miniplates in double configuration

Intervention Type DEVICE

InterFlex plates

InterFlex plates in configuration

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients with recent anterior mandibular fracture located between the mental foramina.
* adults without gender predilection who agreed to follow-up,
* fractures requiring open reduction and internal fixation, and
* those medically fit for general anesthesia were included

Exclusion Criteria

* medically compromised patients,
* fractures with infection,
* pathological or old fractures,
* completely edentulous patients,
* comminuted fractures
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Faculty of Dentistry, Alexandria University

Alexandria, Alexandria Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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0117-12/24

Identifier Type: -

Identifier Source: org_study_id