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NCT Number: NCT07103590

Sagittal Split Plate Versus Two Miniplates in the Treatment of Mandibular Angle Fractures

Mandibular fractures are the second most common maxillofacial fracture after nasal bone fracture. As a result, a lot of research work has gone into improving treatment methods for these fractures including, reduction of immobilization period and enhancement of rigid fixation. One of these modalities is the use of Sagittal Split plate at the angle of the mandible.

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Key information

Conditions

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

Age range

20 year–50 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

Alexandria, Egypt

Location status: Recruiting

Location contact

Peter Naeem El Masry, BDS

CONTACT

[email protected]

Peter Naeem El Masry, BDS

PRINCIPAL_INVESTIGATOR

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 angle mandibular fracture.
  • Fracture that demands open reduction and internal fixation.

Exclusion criteria

  • Medically compromised patients contradicting the operation.
  • Existence of infection at the fracture line.
  • Pathological fracture.
  • An old fracture.

Treatment and study plan

single Sagittal Split plate

Procedure

patients will be treated using a single Sagittal Split plate at the neutral zone of mandible

two conventional miniplates

Procedure

patients will be treated using two conventional miniplates according to Champy's osteosynthesis lines.

Primary outcomes

  1. Change in pain scores

    Time frame: baseline, 24 hours, 1 week, and 6 weeks

    Will be assessed through a 10-point Visual Analogue Scale (VAS) (34). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe).

  2. Change in Maximal Inter-Incisal Mouth

    Time frame: baseline, 24 hours, 1 week, and 6 weeks

    Using a millimeter ruler to measure maximal inter-incisal mouth opening

Secondary outcomes

  1. postoperative infection

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

    observation for any manifestations of wound healing disturbance

  2. change in bone density

    Time frame: baseline and 12 weeks

    Immediate CT (T0) scan will be done and then another CT (T1) will be taken at 12th week to estimate the mean bone density at the fracture line in comparison with the immediate postoperative scan

Study contacts

Contact information is provided by the study sponsor or research team.

Peter Naeem El Masry, BDS

CONTACT

[email protected]

0 12 87142534 ext. +2

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

New Design Sagittal Split Plate Versus Two Miniplates in the Treatment of Mandibular Angle Fractures (Randomized Controlled Clinical Trial)

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 5, 2025
Registry last updated
Aug 5, 2025

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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