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Radiographic and Clinical Evaluation of Three-Dimensional Delta Plate in Internal Fixation of Mandibular Sub-condylar Fractures.

NCT07311239 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-12-30

No results posted yet for this study

Summary

In this study, we intend to examine the efficacy of 3D delta plates through radiographic evaluation of anatomic reduction and vertical ramus height as the main outcome and clinical assessment of pain and range of mandibular movements as secondary outcomes.

This Single arm longtudinal study will include 14 cases of trauma having mandibular sub condylar fractures, in which open reduction and internal fixation are indicated.

After selecting patients according to the inclusion criteria, all patients will undergo open reduction and rigid fixation.

Fracture will be stabilized using 4 hole, 2.0 mm 3-D Delta titanium plates using pre-auricular or retromandibular incision.

Radiographic evaluation using Computed Topograhy (CT) scans will be carried on immediatly after the operation then 3 months post operatively.

While, Clinical assessment will be performed at the following intervals after the surgery( 1 week, 1 month, 3 months)

Conditions

  • Mandible Fracture

Interventions

DEVICE

Three Dimensional Delta Plate

A 3D titanium plate designed with the following measurments: 1 mm thick, 20 mm long, 14 mm wide at the base, 5 mm wide at the apex. It has 4 holes where 2.00 mm screws can fit in.

Sponsors & Collaborators

  • Ahmed Maher Teaching Hospital

    collaborator OTHER_GOV

  • Ain Shams University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-11
Primary Completion
2025-07-19
Completion
2025-10-20

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07311239 on ClinicalTrials.gov