Mandible FractureNCT07574554
Fixation of Mandibular Angle Fracture Using 3D Titanium Miniplate Versus Standard Two Plate Fixation
A study testing Two Standard Plate Fixation and 3D Titanium Miniplate (2.0 mm, 8-hole). in people with Mandible Fracture and Force Measurement, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men only
- Conditions the study is for
- Mandible Fracture, Force Measurement
- What is being tested?
- Two Standard Plate Fixation and 3D Titanium Miniplate (2.0 mm, 8-hole).
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- • Age from 20 to 50years.
- Male .
- Patients with mandibular angle fractures.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of oral and dental medicine ,cairo university , oral and maxillodical department
Cairo
About this study
Official title: Fixation of Mandibular Angle Fracture Using 3D Titanium Miniplate Versus Standard Two Plate Fixation a Randomized Clinical Trial
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.
- Conditions
- Mandible Fracture, Force Measurement
- Being tested
- Two Standard Plate Fixation, 3D Titanium Miniplate (2.0 mm, 8-hole).
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two Standard Plate FixationDevice
Also called two Titanium Miniplates Fixation ,Dual Miniplate Fixation ,Conventional Two-Plate Technique.
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.
3D Titanium Miniplate (2.0 mm, 8-hole).Device
Also called 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
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Two Standard Plate Fixation; Device: 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. Receives: Device: Two Standard Plate Fixation; Device: 3D Titanium Miniplate (2.0 mm, 8-hole). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occlusal force
use bite force measurement device . make patient bite to muser the force (, newton unit).
Measured: first day surgery , second visit 30 days , the last visit 120 days. .
Secondary outcomes (2)
maximal incisal opening.
Ask the patient to open their mouth as wide as possible without feeling pain.
Using a ruler or caliper, measure the vertical distance between the incisal edge of the upper central incisor and the incisal edge of the lower central incisor
Measured: first day surgery , second visit 30 days , the last visit 120 days. .
Patient satisfaction
will be measured on a visual analogue scale (VAS) with zero being unsatisfied and ten being satisfied and happy .
Measured: first day surgery , second visit 30 days , the last visit 120 days. .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 Jan 2025
- Primary completion1 Jun 2026
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandible FractureStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed jassim Ahmed alsubaya, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07574554
- Sponsor's protocol ID
- angle frcture ,Truma
- Status last verified
- Oct 2026
- First submitted
- 10 Jun 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fixation of Mandibular Angle Fracture Using 3D Titanium Miniplate Versus Standard Two Plate Fixation a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07574554
- Acronym / sponsor ID
- angle frcture ,Truma
- Conditions
- Mandible Fracture, Force Measurement
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fixation using standard Two plate titanium. | Active comparator | Device: Two Standard Plate Fixation, Device: 3D Titanium Miniplate (2.0 mm, 8-hole).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. |
| 3D titanium miniplate | Experimental | Device: Two Standard Plate Fixation, Device: 3D Titanium Miniplate (2.0 mm, 8-hole).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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- • Age from 20 to 50years.
Key exclusion criteria (7 listed)
- • Patients with contraindication to general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Two Standard Plate FixationAlso: two Titanium Miniplates Fixation ,Dual Miniplate Fixation ,Conventional Two-Plate Technique.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. | Device | 3D titanium miniplate, fixation using standard Two plate titanium. |
| 3D Titanium Miniplate (2.0 mm, 8-hole).Also: Single 3D Titanium Plate, 2.0 mm Thickness, 6-Hole Rectangular 6-Hole ,3D Titanium Miniplate 3D Contoured Titanium Plate, 2.0 mm, 6-HoleSingle 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. | Device | 3D titanium miniplate, fixation using standard Two plate titanium. |
Primary outcome
Occlusal force
Time frame: first day surgery , second visit 30 days , the last visit 120 days. .
use bite force measurement device . make patient bite to muser the force (, newton unit).
2 secondary outcomes
maximal incisal opening.
Time frame: first day surgery , second visit 30 days , the last visit 120 days. .
Patient satisfaction
Time frame: first day surgery , second visit 30 days , the last visit 120 days. .
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two Standard Plate Fixation and 3D Titanium Miniplate (2.0 mm, 8-hole). in people with Mandible Fracture and Force Measurement, 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: under way, not looking for participants, as of the sponsor's last update on 21 Oct 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?
This study is still under way. Results are not available in the source record yet.
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?
Occlusal force (time frame: first day surgery , second visit 30 days , the last visit 120 days. .). 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 21 Oct 2026.