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CompletedNCT04719325Updated Jan 22, 2021

Herbert Screw vs Lag Screw Fixation in Anterior Mandibular Fracture Treatment

An interventional study of Herbert screw and Lag screw in Mandibular Fractures, sponsored by Hams Hamed Abdelrahman. Completed at 1 site in Egypt. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-01-22.

Sponsored by Hams Hamed Abdelrahman · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Oct 2019, registered Jan 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Mandibular Fractures
03

In context

Mandibular Fractures

81 studies on the registry are indexed under Mandibular Fractures; 20 are open to participants now.

This study's enrollment of 12 is below the median of 22 across 62 interventional studies indexed under Mandibular Fractures.

Browse Mandibular Fractures studies →

Lead sponsor

Hams Hamed Abdelrahman is the lead sponsor of 107 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion criteria

  • Medically compromised patients contradicting operations.
  • Existence of infection at the fracture line.
  • Pathological fracture.
  • An old fracture.
  • Completely edentulous patient
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Herbert screw

    Other: Herbert screw

  • Active comparator
    Lag screw

    Other: Lag screw

Interventions

  • OtherHerbert screw

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

  • OtherLag 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.

06

What researchers measure

Primary outcomes

  1. Change in bone density

    By using digital orthopantomogram bone density was evaluated

    Time frame: baseline and 3 months

  2. 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)

    Time frame: 24 hours, 1 week , 4 Weeks and 6 weeks

  3. presence of Intra-fragmentary mobility

    assessed by bi-manual palpation across the fracture site

    Time frame: 24 hours

07

Study locations

1 site
  • Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
    Alexandria, Azarita 00203, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04719325
Lead sponsor
Hams Hamed Abdelrahman
Responsible party
Hams Hamed Abdelrahman (Assistant lecturer of DPH and Clinical statistician, Alexandria University) — Sponsor-investigator
First posted
Jan 22, 2021
Start date
Oct 18, 2019
Primary completion
Apr 15, 2020
Completion
Jun 15, 2020
Last update
Jan 22, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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