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

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07103590

Enrollment

Registered

2025-08-05

Start date

2025-07-16

Completion date

2025-12-01

Last updated

2025-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mandible Fracture

Brief summary

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

PROCEDUREsingle Sagittal Split plate

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

PROCEDUREtwo conventional miniplates

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 50 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in pain scores	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).
Change in Maximal Inter-Incisal Mouth	baseline, 24 hours, 1 week, and 6 weeks	Using a millimeter ruler to measure maximal inter-incisal mouth opening

Secondary

Measure	Time frame	Description
postoperative infection	24 hours, 1 week, and 6 weeks	observation for any manifestations of wound healing disturbance
change in bone density	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

Countries

Egypt

Contacts

Primary ContactPeter Naeem El Masry, BDS

peternaderelmasry@gmail.com0 12 87142534

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 10, 2026