This randomized clinical study aims to evaluate the clinical and radiographic outcomes of a novel Pin Buckle bone plate compared with conventional two-miniplate fixation for the management of anterior mandibular (symphysis and parasymphysis) fractures. Twenty adult patients requiring open reduction and internal fixation will be randomly allocated into two equal groups. The study group will receive fixation using the Pin Buckle bone plate, while the control group will be treated using conventional titanium miniplates. Clinical outcomes including pain, edema, wound healing, and postoperative complications will be evaluated during the postoperative follow-up period. Radiographic assessment using computed tomography (CT) will be performed immediately after surgery and at 6 months to evaluate bone density. The study seeks to determine whether the Pin Buckle bone plate provides improved postoperative healing and functional outcomes compared with conventional miniplate fixation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
A titanium Pin Buckle bone plate used for internal fixation of anterior mandibular fractures following open reduction.
Conventional titanium miniplates used for internal fixation of anterior mandibular fractures following open reduction according to Champy's principles.
Suez Canal University, Faculty of Dentistry
Ismailia, Egypt
Radiographic Bone Density
Bone density at the fracture site was measured in Hounsfield Units (HU) on multislice CT using standardized regions of interest to evaluate osseous healing.
Time frame: Preoperative, immediately postoperative and after 6 months
Wound Healing
Wound healing was assessed clinically using the Southampton Wound Assessment Scale, which evaluates postoperative wound healing based on the presence and severity of normal healing, erythema, bruising, discharge, wound dehiscence, and infection. Higher grades indicate poorer wound healing.
Time frame: Day 1, Day 7, and Day 14
Postoperative Pain
Pain intensity was assessed using a 10-cm Visual Analogue Scale (VAS), where 0 indicated no pain and 10 indicated the worst pain imaginable.
Time frame: Day 1, Day 7, and Day 14
Postoperative Edema
Facial edema was evaluated clinically by visual inspection and palpation and categorized as none, low-grade, intermediate-grade, or high-grade according to the severity of facial swelling.
Time frame: Day 1, Day 7, and Day 14
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