Back to resultsHerbert Screw vs Lag Screw Fixation in Anterior Mandibular Fracture Treatment
Primary Purpose
Mandibular Fractures
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Herbert screw
Lag screw
Sponsored by
About this trial
This is an interventional treatment trial for Mandibular Fractures
Eligibility Criteria
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
Sites / Locations
- Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Herbert screw
Lag screw
Arm Description
Outcomes
Primary Outcome Measures
Change in bone density
By using digital orthopantomogram bone density was evaluated
change in pain scores
assessed through a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)
presence of Intra-fragmentary mobility
assessed by bi-manual palpation across the fracture site
Secondary Outcome Measures
Full Information
NCT ID
NCT04719325
First Posted
January 17, 2021
Last Updated
January 20, 2021
Sponsor
Hams Hamed Abdelrahman
1. Study Identification
Unique Protocol Identification Number
NCT04719325
Brief Title
Herbert Screw vs Lag Screw Fixation in Anterior Mandibular Fracture Treatment
Official Title
Comparative Study of Herbert Screw vs Lag Screw Fixation in Anterior Mandibular Fracture Treatment (a Clinical and Radiographic Study)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 18, 2019 (Actual)
Primary Completion Date
April 15, 2020 (Actual)
Study Completion Date
June 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hams Hamed Abdelrahman
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mandibular Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Herbert screw
Arm Type
Experimental
Arm Title
Lag screw
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Herbert screw
Intervention Description
Fracture line exposed through intra-oral approach. bone reduction into proper anatomical occlusion and application of Herbert screw
Intervention Type
Other
Intervention Name(s)
Lag screw
Intervention Description
Fracture line exposed through intra-oral approach. bone reduction into proper anatomical occlusion. Application of either lag screw according to Champy's osteosynthesis lines.
Primary Outcome Measure Information:
Title
Change in bone density
Description
By using digital orthopantomogram bone density was evaluated
Time Frame
baseline and 3 months
Title
change in pain scores
Description
assessed through a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)
Time Frame
24 hours, 1 week , 4 Weeks and 6 weeks
Title
presence of Intra-fragmentary mobility
Description
assessed by bi-manual palpation across the fracture site
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
City
Alexandria
State/Province
Azarita
ZIP/Postal Code
00203
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Herbert Screw vs Lag Screw Fixation in Anterior Mandibular Fracture Treatment
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