Evaluation of Customized V Plate Versus Conventional Miniplates of Mandibular Angle Fracture

NCT03761524 | Unknown DMC

• 1 other identifier: 543
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study to evaluate the effect of customized V pattern plate fixation versus a conventional superior-inferior mini plates fixation of mandibular angle fracture on mouth opening and radio graphical parameters.

Conditions

Mandibular Fractures

Keywords

Angle fracture; superior-inferior plate fixation; custom made plate fixation; postoperative complications

Outcome Measures

Primary Outcomes (2)

• Mouth Opening

  Mouth Opening is evaluated by measurement of maximal interincisal opening between maxilaary and mandibular central incisiors by the caliper and measuring unit is mm

  Every week for 1 month ,3 months and 6 months postoperative

• Radiographical parameters

  Radiographical parameters (Bone Density) is detected through CT scan to evaluate bone density in Hounsfield unit in the area of plate fixation to determine the effect of the plate stress over the fracture site Measures format will be summarized as mean

  At 3 and 6 months postoperatively

Secondary Outcomes (1)

• Occlusion

  immediate postoperative day

Study Arms (2)

Customized V plate fixation

EXPERIMENTAL

Computed tomography (CT) scan of the Facial bones (Axial cuts, DICOM file, Gantry tilt zero and minimal thickness of 1mm )is taken for the patients and a customized V pattern plate

Procedure: Customized V plate fixation

Conventional miniplates fixation

ACTIVE COMPARATOR

Conventional superior-inferior miniplates fixation of mandibular angle fixation

Procedure: Conventional miniplates fixation

Interventions

Customized V plate fixation PROCEDURE

(CT) scan is taken for the patients and a customized V pattern plate will be designed .Intraoral approach will be done to expose the angle fracture.Fracture site will be exposed and reduced in normal anatomic position guided by the CAD/CAM plate. MMF will be done.Fracture fragments will be fixed using CAD/CAM plate .

Customized V plate fixation

Conventional miniplates fixation PROCEDURE

Intraoral approach will be done to expose the angle fracture.Fracture site will be exposed and reduced in normal anatomic position. MMF will be done.Fracture fragments will be fixed using conventional miniplates fixation of angle fracture.

Conventional miniplates 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 unfavorable angle fracture indicated for Open reduction internal fixation alone or in combination with fracture elsewhere in the mandible or midrace.
• Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome

You may not qualify if:

• Patients with systemic disease (may affect normal healing).
• Patients with old and/or malunited fractures (affect accuracy of reduction of the fractured segments).
• Patients whom cannot tolerate follow up intervals (affect accuracy of study results).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry-Cairo University

Cairo, 11599, Egypt

Location

Related Publications (1)

• Saleh HO, Moussa BG, Salah Eddin KA, Noman SA, Salah AM. Assessment of CAD/CAM Customized V Pattern Plate Versus Standard Miniplates Fixation in Mandibular Angle Fracture (Randomized Clinical Trial). J Maxillofac Oral Surg. 2023 Dec;22(4):995-1005. doi: 10.1007/s12663-023-02027-x. Epub 2023 Oct 27.

  PMID: 38105847 DERIVED

MeSH Terms

Conditions

Mandibular Fractures; Postoperative Complications

Condition Hierarchy (Ancestors)

Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hiba O Saleh, Phd.student

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hiba O Saleh, Phd.student

CONTACT

00201010389391; dr.hiba2013@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Because the two interventions used in this trial are easily recognized by the participants and the investigator, neither the investigator nor the participant can be blinded. But, assessor and the statistician will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 3, 2018
• Study Start: August 1, 2019
• Primary Completion: August 1, 2021
• Study Completion: September 1, 2021
• Last Updated: July 29, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)