Mandibular Fractures Clinical Trial
Official title:
Comparative Study of Herbert Screw vs Lag Screw Fixation in Anterior Mandibular Fracture Treatment (a Clinical and Radiographic Study)
Verified date | January 2021 |
Source | Alexandria University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | June 15, 2020 |
Est. primary completion date | April 15, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt | Alexandria | Azarita |
Lead Sponsor | Collaborator |
---|---|
Hams Hamed Abdelrahman |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in bone density | By using digital orthopantomogram bone density was evaluated | baseline and 3 months | |
Primary | 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 | |
Primary | presence of Intra-fragmentary mobility | assessed by bi-manual palpation across the fracture site | 24 hours |
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