Patient Specific 3d Titanium Plate Versus Standard Two Mini Plates in the Fixation of Mandibular Angle Fractures (a Randomized Controlled Clinical Trial)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07390734

Enrollment

Registered

2026-02-05

Start date

2025-01-01

Completion date

2026-04-30

Last updated

2026-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mandibular Angle Fracture

Keywords

three dimensional plates, mandibular angle fracture, patient specific plate

Brief summary

To compare the effectiveness of custom-made (3D) titanium plates to standard two titanium mini plates in fixation of mandibular angle fracture.

Detailed description

Eighteen patients with mandibular angle fractures will be selected. In nine fractures, custom-made three dimensional titanium plates will be used for fracture fixation (study group); while in the other nine, conventional two mini plates will be used (control group),via intra oral approach (combined with transbuccal approach) for both groups. Patients will be evaluated clinically, and radiographically (immediate and four months post operative) to evaluate the bone density at the fracture line.

Interventions

DEVICEcustom-made 3D titanium plates

custom-made 3D titanium plates through intaoral and transbuccal approach .

DEVICEstandared two mini plates

internal fixation with standared two mini plates through intaoral and transbuccal approach.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

Participants complying with the inclusion criteria will be randomly assigned using a computer-generated list of random numbers to one of the two arms. Allocation will be performed by a trial independent individual and the allocation ratio is intended to be equal. Allocation will be in equal blocks to ensure that the study groups have equal number of participants.

Intervention model description

Randomized controlled clinical trial

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

1. Patients suffering from mandibular angle fracture indicated for open reduction and fixation. 2. Non infected mandibular angle fractures present less than two weeks. 3. Good oral hygiene.

Exclusion criteria

1. Medically compromised patients contradicting operation (ASA III, IV \& V). 2. Patients receiving radiotherapy or chemotherapy. 3- Bone diseases (Osteoporosis, Osteopetrosis, Osteomalacia…etc.) 4- Pathological fracture. 5- Old untreated fracture.

Design outcomes

Primary

Measure	Time frame	Description
Radiographic evaluation for the assessment of mean bone density at the fracture line	4 months	Mean bone density at the fracture line was assessed using Computed Tomography (CT) scan in Hounsfield Units (HU)

Secondary

Measure	Time frame	Description
Post operative pain	3 months	\- Post operative pain This will be subjectively evaluated with a visual analogue scale (VAS) with values from 0 (no pain) to 10 (strongest pain).

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026