Herbert Screw vs Lag Screw Fixation in Anterior Mandibular Fracture Treatment

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04719325
• Other study ID #: herbert screw
• Status: Completed
• Phase: N/A
• Start date: October 18, 2019
• Est. completion date: June 15, 2020

Study information

• Verified date: January 2021
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Fractures, Bone
• Mandibular Fractures

Intervention

Other:
• Herbert screw
Fracture line exposed through intra-oral approach. bone reduction into proper anatomical occlusion and application of Herbert screw
• 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.

Locations

Country	Name	City	State
Egypt	Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt	Alexandria	Azarita

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

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