Comparing Bone Healing in Jaw Fractures Fixed With Herbert Screws Versus 3D Miniplates (herbert screw)
"Comparative Assessment of Interfragmentary Bone Density in Anterior Mandibular Fracture Fixation Using Second Generation Herbert Screws Versus 3-Dimensional Miniplates: A Randomized Clinical Trial"
the goal of this clinical trial is to compare two methods of fixing fractures in the front part of the jaw (mandible): second-generation Herbert screws and 3-dimensional miniplates.
Importance:
Choosing the right fixation method is crucial for proper bone healing after a jaw fracture.
Participants:
Patients with recent anterior mandibular fractures requiring surgery.
Key Findings:
The study assessed which method better maintained bone density around the fracture, indicating potential benefits for healing.
Implications:
Understanding the effectiveness of these methods aids healthcare providers in making informed decisions, ultimately improving patient outcomes.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dina metwally
- Phone Number: 01224433252
- Email: dina.abdo@dentistry.cu.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
•Adult patients aged 18 years or older, irrespective of gender.
- Anterior mandibular fractures indicated for open reduction and internal fixation (inter-foraminal).
- Dentate/partially dentate patients.
Exclusion Criteria:
•Medically compromised patients contradicting operation (ASA III, IV & V).
- Comminuted fractures.
- Completely edentulous patients.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: interventional group
|
•The second-generation Herbert screw has emerged as a minimally invasive alternative, offering compression across fracture lines and requiring less surgical exposure.
|
|
Active Comparator: comparator group
|
•Conventional fixation using 3D miniplates has been widely accepted for managing anterior mandibular fractures because of their ability to provide stable three-dimensional support
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Interfragmentary Bone Density
Time Frame: Immediately postoperative (within one week) and after 3 months
|
Immediately postoperative (within one week) and after 3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 252
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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