Evaluation Of New Shape of 3D Bone Plate in the Treatment of Posterior Mandibular Fractures
Posterior Mandibular Fractures Involving the Body or Angle Region
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - 60 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 20 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
comparing new design of 3D titanium bone plate with less number of screws with conventional two miniplates in the treatment of posterior mandibular fractures involving the body or angle region
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- Adult patients aged 18 to 60 years old.
- Adult patients of both genders.
- Patients classified as American Society of Anesthesiologists (ASA) physical status I.
- Patients presenting with simple unilateral posterior mandibular fractures involving the mandibular body or angle requiring open reduction and internal fixation.
Exclusion Criteria:
- Pregnant or lactating women.
- ASA II,III,IV
- Patients with associated maxillofacial injuries that may interfere with study outcomes.
- Patients with comminuted mandibular fractures that requires reconstruction plate
- Patients with infected fractures.
- Patients with pathological fractures
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- Single masked
Pin Buckle (study) group
ten patients with posterior mandibular fractures involving the body or angle region, were treated with pin buckle bone plate
Procedure: ORIF using Pin Buckle bone plate
conventional two miniplates (control) group
ten patients with posterior mandibular fractures involving the body or angle region, were treated with conventional two miniplates
Procedure: ORIF using conventional two miniplates
ORIF using Pin Buckle bone plate PROCEDURE
open reduction and internal fixation
ORIF using conventional two miniplates PROCEDURE
Open Reduction and Internal Fixation
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Change in Radiographic Fracture-Line Width
Time frame: Immediately postoperatively (baseline), 3 months, and 6 months postoperatively.
The width of the fracture line will be measured in millimeters using DIGORA image analysis software on standardized digital panoramic radiographs. Measurements will be performed at three standardized points (superior, middle, and inferior) along the visible fracture line, and the mean value will be calculated. Changes from baseline will be assessed at 3 and 6 months postoperatively and compared between the study and control groups.
Secondary measures
Change in Radiographic Bone Density at the Fracture Site
Time frame: Immediately postoperatively (baseline), 3 months, and 6 months postoperatively.
Radiographic bone healing will be assessed by measuring the mean grayscale value at the fracture site using DIGORA image analysis software on standardized digital panoramic radiographs. Measurements will be performed using a standardized region of interest (ROI) at the immediate postoperative baseline, 3 months, and 6 months postoperatively. The change in mean grayscale values from baseline to 3 and 6 months will be evaluated and compared between the study and control groups.
Postoperative Pain Intensity
Time frame: Postoperative days 1, 7, and 14.
Postoperative pain intensity will be evaluated using a 10-cm Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst pain imaginable). Patients will be asked to indicate their pain intensity at each follow-up assessment. Pain scores will be compared between the study and control groups.
Postoperative Facial Edema
Time frame: Preoperatively (baseline) and postoperative days 1, 7, and 14.
Facial edema will be assessed using standardized tape measurements between two anatomical landmarks: the tragus and corner of the mouth, and the lateral canthus and gonion. The sum of the two measurements will be calculated. Changes in the summed measurements relative to the preoperative baseline will be used to evaluate postoperative facial edema and compared between the study and control groups.
Postoperative Wound Healing
Time frame: Postoperative days 1, 7, and 14.
Wound healing will be evaluated clinically using a structured scoring system consisting of five parameters: wound size reduction, tissue appearance, wound exudate, pain and inflammatory response, and mucosal integrity. Each parameter will be scored from 0 (poor) to 2 (good), resulting in a total score ranging from 0 to 10, with higher scores indicating better wound healing. Total wound healing scores will be compared between the study and control groups.
Clinical Stability of Fracture Segments
Time frame: Immediately postoperatively and 6 months postoperatively.
Fracture stability will be assessed by bimanual digital palpation to detect mobility between fracture segments during functional mandibular movements and manual manipulation. Fractures will be classified as stable (absence of detectable movement) or unstable (presence of detectable movement). The proportion of stable fractures will be compared between the study and control groups.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
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1 locations
Faculty of Dentistry / Suez Canal UniversityIsmailia, Ismailia Governorate, EgyptStatus unknown
Study team and timeline
- Lead sponsor
- Suez Canal University
- Study start
- Jul 18, 2025 Actual
- Primary completion
- Mar 10, 2026 Actual
- Study completion
- Sep 10, 2026 Actual
- First posted
- Nov 10, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Clinical And Radiographic Evaluation Of Pin Buckle Bone Plate in the Treatment of Posterior Mandibular Fractures: A Randomized Study
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026