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Completed

NCT Number: NCT04396054

Comparison of Double Y-shaped Plates and Lag Screws in Fixation of Anterior Mandibular Fractures

This study is a prospective randomized controlled clinical trial. It was performed on sixteen patients with anterior mandibular fractures, to compare Double Y-shaped plates and Lag Screws in fracture fixation from clinical and radiographic perspectives.

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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

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Alexandria, 21411, Egypt

About this study

This study is a prospective randomized controlled clinical trial. It was performed on sixteen patients with anterior mandibular fractures, selected from those admitted to the Emergency Department of Alexandria University Hospital. Ethical approval for the study was obtained from the regional Ethical Review Board of the Faculty of Dentistry, Alexandria University. A written informed consent was signed by patients before the operation.

Patients were divided equally into two groups, each consisting of eight patients. Assignment of each patient into one of either group was done using computer random numbers.

Group 1: underwent open reduction and internal fixation using two lag screws. Group 2: underwent open reduction and internal fixation using double Y-shaped plates.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients of both genders
  • with age ranging from 25 to 45 years,
  • suffering from anterior fractures of the mandible (symphyseal or parasymphyseal)

Exclusion criteria

  • old fractures,
  • infected fractures
  • comminuted fractures

Treatment and study plan

Lag Screws

Device

Method of internal fixation

double Y-shaped plates

Device

Method of internal fixation

Primary outcomes

  1. progress of fracture healing in the postoperative period

    Time frame: after 6 months

    Measurement of bone density in the fracture line using CBCT at 6 points and calculation of mean bone density

  2. Sensory nerve function using dental probe to assess sensory changes along mental nerve distribution and comparing it to the contralateral side

    Time frame: up to 6 months

    Detection of nerve injury by examining sensory nerve function using dental probe to assess sensory changes along mental nerve distribution and comparing it to the contralateral side

Sponsors and collaborators

Lead sponsor

Lydia Nabil

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 20, 2020
Registry last updated
May 20, 2020

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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