- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04719325
Herbert Screw vs Lag Screw Fixation in Anterior Mandibular Fracture Treatment
Comparative Study of Herbert Screw vs Lag Screw Fixation in Anterior Mandibular Fracture Treatment (a Clinical and Radiographic Study)
14 patients having recent anterior mandibular fracture divided into two groups. Group A has 6 patients and treated using Herbert bone screw, and group B has 6 patients and treated using lag screw.
Clinical follow-up was conducted after 24-hours, one, four, six, and twelve weeks. In addition, a radiographic investigation was performed after twelve weeks to estimate the mean bone density across the fracture line.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Azarita
-
Alexandria, Azarita, Egypt, 00203
- Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria
- Patients suffering from recent, uninfected anterior mandibular fracture.
- Adult patients from 20-60 years old with no gender predilection agreed to present for follow-up visits for a minimum postoperative period of 3 months.
- Fracture that demands open reduction and internal fixation.
Exclusion criteria
- Medically compromised patients contradicting operations.
- Existence of infection at the fracture line.
- Pathological fracture.
- An old fracture.
- Completely edentulous patient
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Herbert screw
|
Fracture line exposed through intra-oral approach.
bone reduction into proper anatomical occlusion and application of Herbert screw
|
Active Comparator: Lag screw
|
Fracture line exposed through intra-oral approach.
bone reduction into proper anatomical occlusion.
Application of either lag screw according to Champy's osteosynthesis lines.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in bone density
Time Frame: baseline and 3 months
|
By using digital orthopantomogram bone density was evaluated
|
baseline and 3 months
|
change in pain scores
Time Frame: 24 hours, 1 week , 4 Weeks and 6 weeks
|
assessed through a 10-point Visual Analogue Scale (VAS).
(0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)
|
24 hours, 1 week , 4 Weeks and 6 weeks
|
presence of Intra-fragmentary mobility
Time Frame: 24 hours
|
assessed by bi-manual palpation across the fracture site
|
24 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- herbert screw
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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