Anterior Mandibular Fractureherbert screwNCT07826416
Comparing Bone Healing in Jaw Fractures Fixed With Herbert Screws Versus 3D Miniplates
A study testing headless compression screw and 3D mini plates in people with Anterior Mandibular Fracture, run by Cairo University.
Trial summary
the goal of this clinical trial is to compare two methods of fixing fractures in the front part of the jaw (mandible): second-generation Herbert screws and 3-dimensional miniplates. Importance: Choosing the right fixation method is crucial for proper bone healing after a jaw fracture. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anterior Mandibular Fracture
- What is being tested?
- headless compression screw and 3D mini plates
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to Apr 2027
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- •Adult patients aged 18 years or older, irrespective of gender.
- Anterior mandibular fractures indicated for open reduction and internal fixation (inter-foraminal).
- Dentate/partially dentate patients.
Who cannot join
- •Medically compromised patients contradicting operation (ASA III, IV \& V).
- Comminuted fractures.
- Completely edentulous patients.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: "Comparative Assessment of Interfragmentary Bone Density in Anterior Mandibular Fracture Fixation Using Second Generation Herbert Screws Versus 3-Dimensional Miniplates: A Randomized Clinical Trial"
the goal of this clinical trial is to compare two methods of fixing fractures in the front part of the jaw (mandible): second-generation Herbert screws and 3-dimensional miniplates.
Importance:
Choosing the right fixation method is crucial for proper bone healing after a jaw fracture.
Participants:
Patients with recent anterior mandibular fractures requiring surgery.
Key Findings:
The study assessed which method better maintained bone density around the fracture, indicating potential benefits for healing.
Implications:
Understanding the effectiveness of these methods aids healthcare providers in making informed decisions, ultimately improving patient outcomes.
- Conditions
- Anterior Mandibular Fracture
- Being tested
- headless compression screw, 3D mini plates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
headless compression screwDevice
•The second-generation Herbert screw has emerged as a minimally invasive alternative, offering compression across fracture lines and requiring less surgical exposure.
3D mini platesDevice
•Conventional fixation using 3D miniplates has been widely accepted for managing anterior mandibular fractures because of their ability to provide stable three-dimensional support
| Study group | Role | What they receive |
|---|---|---|
| interventional group | Experimental | Not described Receives: Device: headless compression screw |
| comparator group | Active comparator | Not described Receives: Device: 3D mini plates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interfragmentary Bone Density
Measured: Immediately postoperative (within one week) and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Mandibular 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Abd El Aziz Metwally, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826416
- Sponsor's protocol ID
- 252
- Acronym
- herbert screw
- Status last verified
- Aug 2026
- First submitted
- 12 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Comparative Assessment of Interfragmentary Bone Density in Anterior Mandibular Fracture Fixation Using Second Generation Herbert Screws Versus 3-Dimensional Miniplates: A Randomized Clinical Trial"
- ClinicalTrials.gov ID
- NCT07826416
- Acronym / sponsor ID
- herbert screw / 252
- Conditions
- Anterior Mandibular Fracture
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 17 Sep 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.
the goal of this clinical trial is to compare two methods of fixing fractures in the front part of the jaw (mandible): second-generation Herbert screws and 3-dimensional miniplates.
Importance:
Choosing the right fixation method is crucial for proper bone healing after a jaw fracture.
Participants:
Patients with recent anterior mandibular fractures requiring surgery.
Key Findings:
The study assessed which method better maintained bone density around the fracture, indicating potential benefits for healing.
Implications:
Understanding the effectiveness of these methods aids healthcare providers in making informed decisions, ultimately improving patient outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interventional group | Experimental | Device: headless compression screw |
| comparator group | Active comparator | Device: 3D mini plates |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- •Adult patients aged 18 years or older, irrespective of gender.
Key exclusion criteria (3 listed)
- •Medically compromised patients contradicting operation (ASA III, IV \& V).
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 |
|---|---|---|
| headless compression screw•The second-generation Herbert screw has emerged as a minimally invasive alternative, offering compression across fracture lines and requiring less surgical exposure. | Device | interventional group |
| 3D mini plates•Conventional fixation using 3D miniplates has been widely accepted for managing anterior mandibular fractures because of their ability to provide stable three-dimensional support | Device | comparator group |
Primary outcome
Interfragmentary Bone Density
Time frame: Immediately postoperative (within one week) and after 3 months
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 17 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Anterior Mandibular Fracture
Not yet recruiting
Evaluation of Condylar Position After Anterior Mandibular Fracture Fixation Using Plates Versus Headless Compression Screws
Anterior Mandibular Fracture
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.
Questions about this trial
What is this clinical trial studying?
A study testing headless compression screw and 3D mini plates in people with Anterior Mandibular Fracture, run by Cairo University.
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 3 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: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Dina metwally (01224433252, dina.abdo@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interfragmentary Bone Density (time frame: Immediately postoperative (within one week) and after 3 months). 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 17 Sep 2026.