Trials Sponsors Conditions Drugs Pricing

Conditions

Keywords

anterior mandibular fracturesymphyseal fracturepara-symphyseal fractureInterFlex platefunctionally stabilized fixationminiplate

Outcome Measures

Primary Outcomes (1)

Radiographic evaluation for the assessment of mean bone density at the fracture line
Mean bone density at the fracture line was assessed using Cone-Beam Computed Tomography (CBCT) scan in Hounsfield Units (HU)
3 months

Secondary Outcomes (1)

Clinical evaluation for pain
six weeks

Other Outcomes (1)

Clinical evaluation for Intra-fragmentary mobility
six weeks

Study Arms (2)

Patients with anterior mandibular fracture managed with conventional miniplates

ACTIVE COMPARATOR

Patients with anterior mandibular fracture managed with conventional miniplates

Device: conventional miniplates

Patients with anterior mandibular fracture managed with InterFlex plates

EXPERIMENTAL

Patients with anterior mandibular fracture managed with InterFlex plates

Device: InterFlex plates

Interventions

conventional miniplatesDevice

conventional miniplates in double configuration

Patients with anterior mandibular fracture managed with conventional miniplates

InterFlex platesDevice

InterFlex plates in configuration

Patients with anterior mandibular fracture managed with InterFlex plates

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

patients with recent anterior mandibular fracture located between the mental foramina.
adults without gender predilection who agreed to follow-up,

Sponsors & Collaborators

Alexandria University
Otherlead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Alexandria Governorate, 21523, Egypt

Enrollment

18 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: INVESTIGATOR
Masking Details: 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
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 13, 2024

First Posted

December 18, 2024

Study Start

January 25, 2024

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (1)

Study Arms (2)

Patients with anterior mandibular fracture managed with conventional miniplates

Patients with anterior mandibular fracture managed with InterFlex plates

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (1)

Study Arms (2)

Patients with anterior mandibular fracture managed with conventional miniplates

Patients with anterior mandibular fracture managed with InterFlex plates

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations