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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

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

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Comparative Study Between Three Different Plating Techniques in Management of Mandibular Parasymphyseal Fractures.

NCT06323122

Mandibular Fractures

COMPLETED

3D Interlocking Miniplates in Fixation of Mandibular Fractures in the Mental Foramen Region: A Split-mouth Study

NCT06939010

Mandibular Fractures Miniplate

COMPLETED PHASE4

Evaluation of Z-shaped Bone Plates in Management of Mandibular Fractures

NCT07184762

Mandibular Fracture Treatment

ACTIVE_NOT_RECRUITING NA

Clinical Assessment of Computer-assisted PEEK Versus Conventional Titanium Plates on Mandibular Body Fractures

NCT03466190

Fracture Mandible Mandibular Fractures

UNKNOWN NA

z Mini-plate With Lingual Extension Versus Conventional 2 Mini Plates

NCT06898710

Mandible Fracture

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Anterior Mandibular Fracture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

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

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

InterFlex plates

Intervention Type DEVICE

InterFlex plates in configuration

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

conventional miniplates

conventional miniplates in double configuration

Intervention Type DEVICE

InterFlex plates

InterFlex plates in configuration

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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