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OpenTrials
Completed

NCT Number: NCT04719325

Herbert Screw vs Lag Screw Fixation in Anterior Mandibular Fracture Treatment

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.

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Key information

Conditions

Mandibular Fractures Craniocerebral Trauma Facial Injuries Fractures, Bone Jaw Fractures Maxillofacial Injuries Nervous System Diseases Skull Fractures Trauma, Nervous System Wounds and Injuries

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Azarita, 00203, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Herbert screw

Other

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

Lag screw

Other

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 outcomes

  1. Change in bone density

    Time frame: baseline and 3 months

    By using digital orthopantomogram bone density was evaluated

  2. change in pain scores

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

    assessed through a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)

  3. presence of Intra-fragmentary mobility

    Time frame: 24 hours

    assessed by bi-manual palpation across the fracture site

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

Comparative Study of Herbert Screw vs Lag Screw Fixation in Anterior Mandibular Fracture Treatment (a Clinical and Radiographic Study)

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 22, 2021
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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