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NCT Number: NCT06938438

Single Locking Miniplates Versus Double Non-Locking Miniplates in 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

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Key information

Conditions

Anterior Mandibular Fracture

Age range

17 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Tanta University

Tanta, 31527, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

single locking miniplate

Procedure

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

double conventional miniplates.

Procedure

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

Primary outcomes

  1. Soft tissue healing

    Time frame: 1 month

    either normal healing or dehiscence.

  2. visual analogue scale

    Time frame: 1 month

    0 representing no pain at all and 10 representing severe pain

  3. Edema

    Time frame: 1 month

    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.

  4. Paraesthesia of lower lip

    Time frame: 6 months

    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.

  5. Occlusion

    Time frame: 6 months

    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. Stability of the fractured segments

    Time frame: 6 months

    stable/unstable based on clinical evaluation by digital palpation, applying pressure across fractured segments

  7. bone healing at the fracture site

    Time frame: 6 months

    The fracture line could or could not be identified on radiograph

  8. hardware failure

    Time frame: 6 months

    either plate fracture or screw loosening

  9. Intergonial distance

    Time frame: 6 months

    Linear measurement by C.T software

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Apr 22, 2025
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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