NCT07574554

Brief Summary

Hypothesis The investigators hypothesis that fixation of mandibular angle fractures using a 3D titanium miniplate will provide better occlusal bite force than intraoral fixation using the standard two-plate technique. The investigators expect that this method will facilitate a faster recovery time for participants to regain baseline occlusion force.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress71%
Jan 2025Nov 2026

Study Start

First participant enrolled

January 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2025

Completed
11 months until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

May 8, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

June 10, 2025

Last Update Submit

May 1, 2026

Conditions

Mandible FractureForce Measurement

Outcome Measures

Primary Outcomes (1)

  • Occlusal force

    use bite force measurement device . make patient bite to muser the force (, newton unit).

    first day surgery , second visit 30 days , the last visit 120 days. .

Secondary Outcomes (2)

  • maximal incisal opening.

    first day surgery , second visit 30 days , the last visit 120 days. .

  • Patient satisfaction

    first day surgery , second visit 30 days , the last visit 120 days. .

Study Arms (2)

fixation using standard Two plate titanium.

ACTIVE COMPARATOR

Intervention Name: Two Standard plat titanium system . Intervention Type: Device Assigned Intervention: Fixation using two titanium miniplates. The first plate is placed at the inferior border of the mandible from the buccal side, fixed with bicortical screws engaging both cortices. The second plate is positioned \~5 mm superior or at the external oblique ridge, fixed with monocortical screws to avoid dental root injury.

Device: Two Standard Plate FixationDevice: 3D Titanium Miniplate (2.0 mm, 8-hole).

3D titanium miniplate

EXPERIMENTAL

Intervention Name: 3D Titanium Miniplate (2.0 mm, 8-hole) Intervention Type: Device Assigned Intervention: Fixation with a single rectangular 2.0 mm 9-hole 3D titanium miniplate. Two diagonally opposite monocortical screws placed first, followed by the remaining two. The plate is contoured with crossbars perpendicular and struts parallel to the fracture line. The upper crossbar is positioned subapically. Fixation is on the lateral cortex or external oblique ridge with proper adaptation.

Device: Two Standard Plate FixationDevice: 3D Titanium Miniplate (2.0 mm, 8-hole).

Interventions

Two Standard Plate FixationDEVICE

Fixation using two titanium miniplates. One plate at the inferior border of the mandible with bicortical screws. Second plate \~5 mm above or at the external oblique ridge with monocortical screws.

Also known as: two Titanium Miniplates Fixation ,Dual Miniplate Fixation ,Conventional Two-Plate Technique.
3D titanium miniplatefixation using standard Two plate titanium.
3D Titanium Miniplate (2.0 mm, 8-hole).DEVICE

Single 2.0 mm 9-hole 3D titanium plate fixed with monocortical screws. Plate contoured with horizontal crossbars perpendicular and vertical struts parallel to fracture line. Screws placed diagonally first.

Also known as: Single 3D Titanium Plate, 2.0 mm Thickness, 6-Hole Rectangular 6-Hole ,3D Titanium Miniplate 3D Contoured Titanium Plate, 2.0 mm, 6-Hole
3D titanium miniplatefixation using standard Two plate titanium.

Eligibility Criteria

Age20 Years - 50 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age from 20 to 50years.
  • Male .
  • Patients with mandibular angle fractures.

You may not qualify if:

  • Patients with contraindication to general anesthesia
  • Patients with comminuted angle fractures.
  • Patients with relevant systemic diseases contraindicating surgery or affecting bone healing.
  • Patients with infected condyle and coronoid fractures.
  • Gun-shot injuries.
  • Edentulous fractures.
  • Pathological fractures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of oral and dental medicine ,cairo university , oral and maxillodical department

Cairo, Egypt

Location

MeSH Terms

Conditions

Mandibular Fractures

Condition Hierarchy (Ancestors)

Jaw FracturesMaxillofacial InjuriesFacial InjuriesCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesSkull FracturesFractures, BoneWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's Degree Candidate

Study Record Dates

First Submitted

June 10, 2025

First Posted

May 8, 2026

Study Start

January 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

May 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)