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Mandibular Parasymphyseal FracturesNCT07651033

3D Titanium Plates for Mandibular Parasymphyseal Fracture Fixation

A study testing 3D Titanium Plates in people with Mandibular Parasymphyseal Fractures, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Mandibular fractures pose significant challenges in maxillofacial surgery due to their frequency, potential for functional impairment, and aesthetic concerns. Open reduction and internal fixation (ORIF) using titanium plates and screws have revolutionized the management of mandibular fractures. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Mandibular Parasymphyseal Fractures
What is being tested?
3D Titanium Plates
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteEgypt
Study dates
15 Dec 2024to 15 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age ranging between 20-60 years.
  • Patients with mandibular parasymphyseal fractures requiring open reduction and fixation..
  • Patients with good health (ASA -I and ASA- II) without any contraindication for surgery or anesthesia.

Who cannot join

  • Patients with pre existing neurological or musculoskeletal disease.
  • Patients with infected fractures.
  • Patients with simultaneous condylar fracture.
  • Patients with regional malignancy.
  • Medically compromised patients.
  • Patients with blood diseases or severe renal disorders.
  • Patients refuse to share in the study.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Dentistery Hospital, Cairo Universiy

    Cairo, Giza Governorate

Other trials in Egypt

About this study

Official title: The Use of 3d Titanium Plates With Two Different Profile Thickness for Open Reduction and Rigid Fixation of Mandibular Parasymphyseal Fracture:Randomised Clinical Trial

Mandibular fractures pose significant challenges in maxillofacial surgery due to their frequency, potential for functional impairment, and aesthetic concerns. Open reduction and internal fixation (ORIF) using titanium plates and screws have revolutionized the management of mandibular fractures.

The advent of 3D printing technology has ushered in a new era of patient-specific implants, offering improved adaptation to individual anatomy and potentially enhancing surgical outcomes.

Read the detailed description

The face is the window through which we perceive the world around us, and the world noted us. It serves a crucial role in human interaction and injuries to it result in devastating emotional sequelae. The human face constitutes the first contact point in several human interactions, thus injuries and/or mutilation of the facial structures may have a disastrous influence on the affected person.

The facial area is one of the most frequently injured parts of the body, and the mandible is one of the most commonly fractured maxillofacial bones. For the past decades, there has been a significant increase in maxillofacial traumas involving mandible. They are mainly caused by vehicular accidents, sport activities, penetrating injuries, physical assault, work-related accident, metabolic diseases or tumors.

The position, prominence, anatomic configuration, mobility and less bone support of the mandible make it one of the most frequent facial bones to be fractured. The mandibular fracture accounts for 36% to 54% of all fractures in the maxillofacial region. Mandible is the 10th most fractured bone in the whole body. They may occur alone or in combination with other facial bone fractures.

It plays a major role in mastication, speech, and deglutition. Its fractures result in severe loss of function and disfigurement. Fractures through the mandible at the level of the Symphysis and or parasymphysis are relatively common and account for approximately 20% of mandibular fractures. These fractures are often associated with a second fracture of the mandible, especially in the subcondylar region.

Fractures of the symphyseal region are often associated with the clinical findings of a widened intragonial distance with resultant malocclusion. Fractures of the anterior mandible lack two of the stabilizing factors provided to fractures of the posterior tooth-bearing mandible: the splinting effects of the masseter and internal pterygoid muscles, which form a natural sling, and the interlocking cusps and fossae of bicuspid and molar teeth.

Internal fixation in long bones has been adapted with particular modifications for the mandible. The disadvantage with these rigid plates was movement of the fracture fragment while tightening the screws resulting in malocclusion. Also, these plates could only be minimally adapted to the fracture fragments and produced more tension on the bone resulting in loosening of screws. They also require an extraoral approach and are highly technique sensitive.

The introduction of the 3-dimension (3D) system for the treatment of mandibular fractures has offered certain advantages over other plating systems. These plates function as internal fixator, achieving stability by 3D plates. A unique advantage of 3D system is that there is no need to adapt plate over the underlying bone, making plate adaptation easier.

Theoretical advantages proposed include close approximation, greater stability across the fracture site, less precision required in plate adaptation because of the internal/external fixator, less alteration in osseous or occlusal relationship upon screw tightening and, and less time required.

Although several materials can be used for manufacture of small plates, generally titanium is used because of its excellent biocompatibility, resistance to corrosion and pliability. Champy's miniplates require intra oral approach, less technique sensitive and produce consistently good results with regard to occlusion and also avoid the need for intermaxillary fixation

Being tested
3D Titanium Plates

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3D Titanium PlatesDevice

    Also called Open Reduction and Rigid Internal Fixation

    to compare 3d titanium plates with two different profile thickness for open reduction and rigid fixation of mandibular parasymphyseal fracture.

Study groups in NCT07651033
Study groupRoleWhat they receive
Group A (3d titanium plates of 2 mm):Active comparatorAbout 9 patients suffered from Mandibular Parasymphyseal Fracture treated by using 3d titanium plates of 2 mm thickness.
Receives: Device: 3D Titanium Plates
Group B (3d titanium plates of 0.7 mm):Active comparatorAbout 9 patients suffered from Mandibular Parasymphyseal Fracture treated by using 3d titanium plates of 0.7 mm thickness.
Receives: Device: 3D Titanium Plates

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment of Postoperative pain

    Treatment of the pain resulted from using 3d titanium plates with two different profile thickness for open reduction and fixation of mandibular Parasymphyseal fracture by using a standardized pain scale.

    Measured: 48 Hours from the operation

Secondary outcomes (1)
  1. Incidence of postoperative Complications

    Secondary outcomes will be evaluated to assess the clinical effectiveness and safety of using 3D titanium plates with different profile thicknesses in the fixation of mandibular body fractures (as infection, malocclusion, and hardwarerelated complications).

    Measured: from1 week to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2026
  2. Study start15 Dec 2024
  3. Primary completion15 Dec 2025
  4. Study completion15 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07651033
Sponsor's protocol ID
Mandibular Fracture
Status last verified
Feb 2025
First submitted
11 Jun 2026
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing 3D Titanium Plates in people with Mandibular Parasymphyseal Fractures, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment of Postoperative pain (time frame: 48 Hours from the operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.

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