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)
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2025
CompletedStudy Start
First participant enrolled
July 16, 2025
CompletedFirst Posted
Study publicly available on registry
August 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedAugust 5, 2025
July 1, 2025
5 months
July 15, 2025
July 29, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Change in pain scores
Will be assessed through a 10-point Visual Analogue Scale (VAS) (34). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe).
baseline, 24 hours, 1 week, and 6 weeks
Change in Maximal Inter-Incisal Mouth
Using a millimeter ruler to measure maximal inter-incisal mouth opening
baseline, 24 hours, 1 week, and 6 weeks
Secondary Outcomes (2)
postoperative infection
24 hours, 1 week, and 6 weeks
change in bone density
baseline and 12 weeks
Study Arms (2)
Test Group
EXPERIMENTALConventional Group
ACTIVE COMPARATORInterventions
patients will be treated using a single Sagittal Split plate at the neutral zone of mandible
patients will be treated using two conventional miniplates according to Champy's osteosynthesis lines.
Eligibility Criteria
You may qualify if:
- Patients suffering from recent, uninfected angle mandibular fracture.
- Fracture that demands open reduction and internal fixation.
You may not qualify if:
- Medically compromised patients contradicting the operation.
- Existence of infection at the fracture line.
- Pathological fracture.
- An old fracture.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University
Alexandria, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2025
First Posted
August 5, 2025
Study Start
July 16, 2025
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
August 5, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share