Clinical trial NCT06938438: Single Locking Miniplates Versus Double Non-Locking Miniplates in Anterior Mandibular Fracture
Official title: Comparison of Single Locking Miniplates Versus Double Non-Locking Miniplates in Fixation of Anterior Mandibular Fracture
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Anterior Mandibular Fracture
Keywords: anterior mandibular fracture
locking miniplate
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 20
Sex: ALL
Minimum age (years): 17
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: Soft tissue healing
timeFrame: 1 month
measure: visual analogue scale
timeFrame: 1 month
measure: Edema
timeFrame: 1 month
measure: Paraesthesia of lower lip
timeFrame: 6 months
measure: Occlusion
timeFrame: 6 months
measure: Stability of the fractured segments
timeFrame: 6 months
measure: bone healing at the fracture site
timeFrame: 6 months
measure: hardware failure
timeFrame: 6 months
measure: Intergonial distance
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Dentistry, Tanta University
Study officials:
affiliation: Faculty of Dentistry, Tanta University, Egypt
name: Nesreen M Ramadan
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Tanta University, Egypt
name: Mohamed M Shoushan, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Tanta University, Egypt
name: Mohamed E Kamal, Ass Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Tanta University, Egypt
name: Maram N Breshah, Lecturer
role: PRINCIPAL_INVESTIGATOR
References: