Three-Dimensional Printing and Three-Dimensional Miniplates in Treatment of Anterior Mandibular Fractures

NCT06898736 | Completed

• 1 other identifier: 3D printing and virtual plan
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

Brief Summary

The primary objective of this study was to evaluate the accuracy of virtual reduction and the prebending of the 3D miniplates on printed models for fixation of anterior mandibular fractures. The secondary objective is to evaluate the bone healing of anterior mandibular reduction.

Conditions

Virtual Plan of Mandibular Fracture

Keywords

Virtual plan

Outcome Measures

Primary Outcomes (2)

• Bone density was measured by Hounsfield units (HU) measured on CT images

  The length and width of the mandible were measured using 3D CT scan with digital callipers in millimetres.

  3 months

• mandible dimensions

  Mandibular length and width were measured using 3D CT scan with digital callipers in millimetres.

  3 months

Study Arms (1)

virual plan before and after mandibular fracture fixation

EXPERIMENTAL

virual plan before and after mandibular fracture fixation and 3D miniplate fixation

Device: 3d miniplate

Interventions

3d miniplate DEVICE

3d miniplate was used for mandibular fracture fixation

virual plan before and after mandibular fracture fixation

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Recent anterior mandibular fractures (within one week).
• Adult patients of both genders (18-50 years old).
• Systematic healthy patients.
• Radiographic evidence of anterior mandibular fracture.

You may not qualify if:

• Medically compromised patients contraindicated for general anaesthesia and bone surgery.
• Comminuted fractures.
• Bilateral anterior mandibular fractures.
• Previously treated fractures.
• Pathological fractures and bone diseases.

Sponsors & Collaborators

• Mansoura University: lead
• Alexandria University: collaborator

Study Sites (3)

oral and maxillofacial department , faculty of dentistry, Alexandria university

Alexandria, Alexandria Governorate, 21526, Egypt

Location

oral and maxillofacial department, faculty of dentistry,Alexandria

Alexandria, Alexandria Governorate, 21526, Egypt

Location

Oral and Maxillofacial Department

Alexandria, Alexandria Governorate, 21526, Egypt

Location

Related Publications (4)

• https://pmc.ncbi.nlm.nih.gov/articles/PMC10709695/

  BACKGROUND

• Ponvel K, Panneerselvam E, Balasubramanian S, Krishna Kumar Raja VB. Evaluation of labial versus labio-inferior lines of osteosynthesis using 3D miniplate for fractures of anterior mandible: A finite element analysis with a pilot clinical trial. Chin J Traumatol. 2019 Oct;22(5):261-269. doi: 10.1016/j.cjtee.2019.08.001. Epub 2019 Aug 9.

  PMID: 31493976 BACKGROUND

• Macdonald B, McAleer S, Kelly S, Chakraverty R, Johnston M, Pollock N. Hamstring rehabilitation in elite track and field athletes: applying the British Athletics Muscle Injury Classification in clinical practice. Br J Sports Med. 2019 Dec;53(23):1464-1473. doi: 10.1136/bjsports-2017-098971. Epub 2019 Jul 12.

  PMID: 31300391 BACKGROUND

• Abou Elkhier MT, Saber ME, Sweedan AO, Elashwah A. Evaluation of accuracy of three-dimensional printing and three-dimensional miniplates in treatment of anterior mandibular fractures: a prospective clinical study. BMC Oral Health. 2025 Apr 28;25(1):649. doi: 10.1186/s12903-025-05935-1.

  PMID: 40296061 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mazen Tharwat Abou Elkhier, principle investigator

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 27, 2025
• Study Start: October 10, 2021
• Primary Completion: October 10, 2024
• Study Completion: March 10, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (3)