Clinical Assessment of Computer-assisted PEEK Versus Conventional Titanium Plates on Mandibular Body Fractures

NCT03466190 | Unknown DMC

• 1 other identifier: CEBD-CU-2018-02-27
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Two groups of patients with mandibular body fractures indicated for Open reduction internal fixation alone or in combination with fractures elsewhere in the mandible or midface. First group will be subjected to traditional titanium internal rigid fixation. Second group will be subjected to custom made PEEK plates.

Conditions

Fracture Mandible; Mandibular Fractures

Keywords

Mandibular body fractures, PEEK plates, titanium plates.

Outcome Measures

Primary Outcomes (1)

• Postoperative occlusion

  Restoration of normal patient occlusion will be assessed using Visual analog scale (VAS) (0-10)

  1 month postoperative

Secondary Outcomes (4)

• Accuracy of the planned reduction

  1st week

• Wound dehiscence

  1 month postoperative

• The need for 2nd surgery

  1 month postoperative

• Operative time

  During operation

Study Arms (2)

Custom made PEEK plate fixation

EXPERIMENTAL

Open Reduction Internal Fixation using Custom made PEEK plates.

Procedure: Custom made PEEK plate fixation

Titanium plate fixation

ACTIVE COMPARATOR

Open Reduction Internal Fixation using conventional titanium plating system.

Procedure: Titanium plate fixation

Interventions

Titanium plate fixation PROCEDURE

Under General Anesthesia, exposure of the fractured mandibular body segments will be done using a standardized surgical approach. Open Reduction Internal Fixation using conventional titanium plates will be performed.

Also known as: Conventional titanium plates

Titanium plate fixation

Custom made PEEK plate fixation PROCEDURE

Under General Anesthesia, exposure of the fractured mandibular body segments will be done using a standardized surgical approach. Open Reduction Internal Fixation using custom made PEEK plates will be performed.

Also known as: Computer-assisted PEEK plate fixation

Custom made PEEK plate fixation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with at least a unilateral body fracture indicated for Open reduction internal fixation alone or in combination with fracture elsewhere in the mandible or midface.
• All ages and both sexes were included in this study.
• Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
• Patients with good general condition allowing major surgical procedure under general anesthesia.
• Patients with physical and psychological tolerance.

You may not qualify if:

• Patients with physical and psychological intolerance. Because psychological stress will affect the immune system and general health.
• Patients with systemic diseases like uncontrolled diabetes mellitus. Because uncontrolled diabetes mellitus has a negative impact on normal bone healing.
• Patients with old and/or mal-union fractures. As they will affect accuracy of reduction of the fractured segments.
• Patient with bad oral hygiene. As it has an influence on normal osseous healing

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Oral and Dental Medicine -Cairo University

Cairo, Giza Governorate, 12613, Egypt

RECRUITING

Related Links

• Open reduction and rigid internal fixation of mandibular condylar fractures by an intraoral approach: a long-term follow-up study of 15 patients
• Accuracy of the Computer-Aided Surgical Simulation (CASS) System in the Treatment of Patients With Complex Craniomaxillofacial Deformity: A Pilot Study.
• A Comparative Evaluation of Fixation Techniques in Anterior Mandibular Fractures Using 2.0 mm Monocortical Titanium Miniplates Versus 2.4 mm Cortical Titanium Lag Screws
• Titanium osteosynthesis hardware in maxillofacial trauma surgery: to remove or remain? A retrospective study.
• Camerani, et al. Reconstruction of frontal bone using specific implant polyether-ether-ketone
• The effect of diabetes mellitus on osseous healing.
• Unfavourable outcomes in maxillofacial injuries: How to avoid and manage
• Stress-induced immune dysregulation: Implications for wound healing, infectious disease and cancer

MeSH Terms

Conditions

Mandibular Fractures

Condition Hierarchy (Ancestors)

Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Study Officials

• Khaled Amr, PhD

  Faculty of Oral and Dental Medicine -Cairo University

  STUDY DIRECTOR

Central Study Contacts

Rofaida A Ahmad, MSc

CONTACT

+201099669299; ro_fy_at@yahoo.com

Rofaida A Ahmad, MSc

CONTACT

+201099669299; rofaidaatef14@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Because the two interventions used in this trial are clearly different and easily recognized by the participants and investigators, neither the investigator nor participants can be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: * A Randomized clinical trial. * A trial will be carried out in hospital of Oral and Maxillofacial surgery department- Faculty of Oral and Dental Medicine Cairo University * Equal randomization: participants with equal probabilities for intervention. * Positive controlled: Both groups receiving treatment. * Parallel group study: Each group of patients receives a single treatment simultaneously.

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: March 15, 2018
• Study Start: August 2, 2017
• Primary Completion: March 2, 2019
• Study Completion: March 2, 2019
• Last Updated: March 15, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)