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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
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06938438
Enrollment
20
Registered
2025-04-22
Start date
2022-03-15
Completion date
2025-09-20
Last updated
2026-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Mandibular Fracture

Keywords

anterior mandibular fracture, locking miniplate

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

Interventions

PROCEDUREsingle locking miniplate

Ten patients in whom anterior mandibular fractures will be fixed with titanium single locking miniplate

PROCEDUREdouble conventional miniplates.

Ten patients in whom, anterior mandibular fractures will be fixed with double conventional titanium miniplates.

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
17 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Soft tissue healing1 montheither normal healing or dehiscence.
visual analogue scale1 month0 representing no pain at all and 10 representing severe pain
Edema1 monthutilizing 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.
Paraesthesia of lower lip6 monthsTwo 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.
Occlusion6 monthsUglesic'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
Stability of the fractured segments6 monthsstable/unstable based on clinical evaluation by digital palpation, applying pressure across fractured segments
bone healing at the fracture site6 monthsThe fracture line could or could not be identified on radiograph
hardware failure6 monthseither plate fracture or screw loosening
Intergonial distance6 monthsLinear measurement by C.T software

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATORNesreen M Ramadan

Faculty of Dentistry, Tanta University, Egypt

PRINCIPAL_INVESTIGATORMohamed M Shoushan, Prof

Faculty of Dentistry, Tanta University, Egypt

PRINCIPAL_INVESTIGATORMohamed E Kamal, Ass Prof

Faculty of Dentistry, Tanta University, Egypt

PRINCIPAL_INVESTIGATORMaram N Breshah, Lecturer

Faculty of Dentistry, Tanta University, Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026