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)
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2020
CompletedFirst Submitted
Initial submission to the registry
January 17, 2021
CompletedFirst Posted
Study publicly available on registry
January 22, 2021
CompletedJanuary 22, 2021
January 1, 2021
6 months
January 17, 2021
January 20, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Change in bone density
By using digital orthopantomogram bone density was evaluated
baseline and 3 months
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)
24 hours, 1 week , 4 Weeks and 6 weeks
presence of Intra-fragmentary mobility
assessed by bi-manual palpation across the fracture site
24 hours
Study Arms (2)
Herbert screw
EXPERIMENTALLag screw
ACTIVE COMPARATORInterventions
Fracture line exposed through intra-oral approach. bone reduction into proper anatomical occlusion and application of Herbert 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Medically compromised patients contradicting operations.
- Existence of infection at the fracture line.
- Pathological fracture.
- An old fracture.
- Completely edentulous patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria, Azarita, 00203, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant lecturer of DPH and Clinical statistician
Study Record Dates
First Submitted
January 17, 2021
First Posted
January 22, 2021
Study Start
October 18, 2019
Primary Completion
April 15, 2020
Study Completion
June 15, 2020
Last Updated
January 22, 2021
Record last verified: 2021-01