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Recruiting NCT07103590

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

No phase Interventional Mandible Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: single Sagittal Split plate, two conventional miniplates.
Who it may be relevant to
Registry conditions: Mandible Fracture. Basic parameters: 20 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Procedure single Sagittal Split plate
    patients will be treated using a single Sagittal Split plate at the neutral zone of mandible
  • Procedure two conventional miniplates
    patients will be treated using two conventional miniplates according to Champy's osteosynthesis lines.

Primary outcome measures

  • Change in pain scores [Time frame: baseline, 24 hours, 1 week, and 6 weeks]
  • Change in Maximal Inter-Incisal Mouth [Time frame: baseline, 24 hours, 1 week, and 6 weeks]
Secondary outcome measures (2)
  • postoperative infection [Time frame: 24 hours, 1 week, and 6 weeks]
  • change in bone density [Time frame: baseline and 12 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alex — Alexandria

Publications

  • El-Masry PN, Mohamed NS, Saber ME. A novel plate design versus two conventional miniplates for treatment of mandibular angle fractures (a pilot randomized controlled clinical trial). BMC Oral Health. 2026 May 9;26(1):867. doi: 10.1186/s12903-026-08474-5. PMID 42104343

Identifiers

NCT: NCT07103590 · 1026-1/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗