NCT06938438

Single Locking Miniplates Versus Double Non-Locking Miniplates in Anterior Mandibular Fracture

Comparison of Single Locking Miniplates Versus Double Non-Locking Miniplates in Fixation of Anterior Mandibular Fracture

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 17 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to compare clinically and radiographically the using of single locking miniplate versus double non-locking miniplates in internal fixation of anterior mandibular fracture

Detailed description

This study will be carried out on twenty adult patients with mandibular symphyeal and parasymphyseal fracture indicated for open reduction and internal fixation. The patients will be recieved, clinically\& radiographically examined and managed at Oral \& Maxillofacial Surgery Department, Faculty of Dentistry, Tanta University. Patients will be randomly divided into two equal groups according to the type of plating system used in fracture fixation: • Group I: Comprised of ten patients in whom anterior mandibular fractures will be fixed with titanium single locking miniplate. • Group II: Comprised of ten patients in whom, anterior mandibular fractures will be fixed with double conventional titanium miniplates. Preoperative evaluation: A thorough clinical examination will be performed for all patients.An intraoral clinical examination will be done to evaluate occlusal status, hematoma, soft tissue laceration, infection and neural disorder. Preoperative radiographic evaluation will be performed including standardized orthopantomograms (OPG) and CT radiographs to document the presence of the fracture and to determine the degree of displacement Surgical Technique: The patients will be operated under inhalational type of general anaesthesia via nasoendotracheal intubation. Disinfection of the surgical field with Betadine and surgical draping, Erich's arch bars will be applied. Mentalis muscle will be exposed and incised perpendicular and deep to the bone, leaving a flap of muscle attached to bone for closure. The mucoperiosteal flap will be raised. In group I: Adequate exposure of the fractured segments and adequate reduction of segments by manual reduction which assured by accurate occlusion and disappearance of step between segments. Once occlusion is achieved through intermaxillary fixation, five hole straight single locking titanium miniplate In group II: According to Champy principle two miniplates will be placed on the inferior border of the mandible and subapically will be used to fix fracture respectively. Postoperative evaluation: All patients of both groups will be evaluated clinically immediately, one week, two weeks, three weeks, four weeks, six weeks, three months and six months post-operatively regarding soft tissue healing, pain, edema, paraesthesia of lower lip, occlusion, stability of the fractured segments and Incidence of hardware failure. Radiographic evaluation: All patients will be evaluated using panoramic x-ray immediately and six months post-operatively. Axial, coronal and 3D CT scan will be done immediately and six months post-operatively. Immediate post-operative panoramic x-ray \& CT scan will be done to display the fracture reduction and and the position of plate at the inferior border. Evaluation of bone healing at the fracture site and hardware failure and intergonial distance

Conditions

• Anterior Mandibular Fracture

Interventions

Type	Name	Description
PROCEDURE	single locking miniplate	Ten patients in whom anterior mandibular fractures will be fixed with titanium single locking miniplate
PROCEDURE	double conventional miniplates.	Ten patients in whom, anterior mandibular fractures will be fixed with double conventional titanium miniplates.

Timeline

• Start date: 2022-03-15
• Primary completion: 2024-12-01
• Completion: 2025-09-20
• First posted: 2025-04-22
• Last updated: 2026-02-03

Locations

1 site across 1 country: Egypt