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

NCT06938438 | Completed

• 1 other identifier: #R-OS-2-22-12
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Anterior Mandibular Fracture

Keywords

anterior mandibular fracture; locking miniplate

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

Group I: single locking miniplate

ACTIVE COMPARATOR

Comprised of ten patients in whom anterior mandibular fractures will be fixed with titanium single locking miniplate

Procedure: single locking miniplate

Group II: double conventional miniplates

ACTIVE COMPARATOR

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

Procedure: double conventional miniplates.

Interventions

double conventional miniplates. PROCEDURE

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

Group II: double conventional miniplates

single locking miniplate PROCEDURE

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

Group I: single locking miniplate

Eligibility Criteria

• Age: 17 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Dentistry, Tanta University

Tanta, 31527, Egypt

Location

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Oral & Maxillofacial Surgery

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 22, 2025
• Study Start: March 15, 2022
• Primary Completion: December 1, 2024
• Study Completion: September 20, 2025
• Last Updated: February 3, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)