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

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

Study Overview

• Status: Completed
• Conditions: Anterior Mandibular Fracture
• Intervention / Treatment: Procedure: single locking miniplate; Procedure: double conventional miniplates.

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

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt, 31527
    • Faculty of Dentistry, Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with displaced symphyseal/ parasymphyseal mandibular fracture
• age group between 17-40 years old

Exclusion Criteria:

• Patients with systemic diseases that may affect bone healing
• Comminuted mandibular fracture.
• Edentulous patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I: single locking miniplate; Comprised of ten patients in whom anterior mandibular fractures will be fixed with titanium single locking miniplate	Procedure: single locking miniplate; Ten patients in whom anterior mandibular fractures will be fixed with titanium single locking miniplate
Active Comparator: Group II: double conventional miniplates; Comprised of ten patients in whom, anterior mandibular fractures will be fixed with double conventional titanium miniplates.	Procedure: double conventional miniplates.; Ten patients in whom, anterior mandibular fractures will be fixed with double conventional titanium miniplates.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Soft tissue healing	either normal healing or dehiscence.	1 month
visual analogue scale	0 representing no pain at all and 10 representing severe pain	1 month
Edema	utilizing a horizontal and vertical guide with a tape on four reference points:tragus of the ear, soft tissue pogonion, pupil and the intersection between lines drawn from pupil centre falling vertically to inferior border of mandible and line parallel to inferior border of the mandible respectively then obtain the percentage of facial swelling, the difference between measurements of the postoperative and preoperative periods was divided by the value of the preoperative period.	1 month
Paraesthesia of lower lip	Two point discrimination test: Score 0: patients could not tell which tip was felt, even if these were morethan 20 mm apart. Score 1: patients could distinguish between tips only when the caliper wascalibrated at between 14 and 20 mm. Score 2: normal sensitivity, patients could discriminate between the tips at ashorter distance than 14 mm.	6 months
Occlusion	Uglesic's questionnaire 1. Evaluation of the occlusion after fracture treatment; 5 points: occlusion altered bilaterally.; 3 points: occlusion altered on one side .1 point: occlusion altered on one side. occlusal adjustment required. 3points: occlusion adequate on both sides but not the same as before injury. 5 points: good occlusion obtained 2. Self-evaluation of chewing after treatment; 5 points: not able to chew 0 points: on soft diet 3 points: on normal diet, but can chew only on one side 5 points: on normal diet	6 months
Stability of the fractured segments	stable/unstable based on clinical evaluation by digital palpation, applying pressure across fractured segments	6 months
bone healing at the fracture site	The fracture line could or could not be identified on radiograph	6 months
hardware failure	either plate fracture or screw loosening	6 months
Intergonial distance	Linear measurement by C.T software	6 months

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Nesreen M Ramadan, Faculty of Dentistry, Tanta University, Egypt; Principal Investigator: Mohamed M Shoushan, Prof, Faculty of Dentistry, Tanta University, Egypt; Principal Investigator: Mohamed E Kamal, Ass Prof, Faculty of Dentistry, Tanta University, Egypt; Principal Investigator: Maram N Breshah, Lecturer, Faculty of Dentistry, Tanta University, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Actual): December 1, 2024
• Study Completion (Actual): September 20, 2025

Study Registration Dates

• First Submitted: April 14, 2025
• First Submitted That Met QC Criteria: April 14, 2025
• First Posted (Actual): April 22, 2025

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: anterior mandibular fracture; locking miniplate
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Facial Injuries; Jaw Fractures; Maxillofacial Injuries; Skull Fractures; Fractures, Bone; Mandibular Fractures
• Other Study ID Numbers: #R-OS-2-22-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No