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

NCT07103590 — Not applicable, Recruiting, 16 participants, Alexandria University

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

Registry	NCT07103590
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	16 (Estimated)
Sponsor	Alexandria University (Other)
Conditions	Mandible Fracture
Interventions	single Sagittal Split plate, two conventional miniplates (Procedure)
Dates	start 2025-07-16, primary completion 2025-12-01 (estimated), completion 2025-12-01 (estimated), first posted 2025-08-05, last updated 2025-08-05
Locations	1 site in Egypt

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Test Group	Experimental	Procedure: single Sagittal Split plate
Conventional Group	Active comparator	Procedure: two conventional miniplates

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.

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 20 Years to 50 Years

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.

+Locations (1)

Facility	City	Country	Status
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University	Alexandria	Egypt	Recruiting

+Publications

Results publication: 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

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Public

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