Anterior Mandibular FracturefractureNCT07826403
Evaluation of Condylar Position After Anterior Mandibular Fracture Fixation Using Plates Versus Headless Compression Screws
A study testing headless compression screw and conventional plates in people with Anterior Mandibular Fracture, run by Cairo University.
Trial summary
This study compares two methods for fixing fractures of the front part of the lower jaw: Conventional plates and screws Headless compression screws Patients are randomly assigned to one of the two treatment groups. 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 conventional plates
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 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 of age from 18 years or older, irrespective of the gender.
- Recent single isolated anterior mandibular fracture (symphyseal or parasymphyseal) indicated for open reduction and internal fixation.
- Dentate or partially dentate patients.
Who cannot join
- Comminuted fractures.
- Medically compromised patients contradicting surgical intervention under general anaesthesia.
- Patients younger than 18 years.
- 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 Evaluation of Condylar Position Following Anterior Mandibular Fracture Fixation Using Conventional Plates Versus Headless Compression Screws: A Randomized Clinical Trial
This study compares two methods for fixing fractures of the front part of the lower jaw:
Conventional plates and screws Headless compression screws
Read more
Patients are randomly assigned to one of the two treatment groups. Researchers will use imaging to see whether either method causes a significant change in the position of the mandibular condyles, which are the parts of the jaw that connect to the jaw joints.
Why it matters: Proper condylar position is important for normal jaw movement, chewing, and overall TMJ function.
Main goal: To determine whether conventional plates or headless compression screws provide better preservation of condylar position after surgery.
The study may help surgeons choose the most appropriate fixation technique for patients with anterior mandibular fractures.
- Conditions
- Anterior Mandibular Fracture
- Being tested
- headless compression screw, conventional plates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
headless compression screwDevice
Headless compression screws provide interfragmentary compression along the long axis of the mandible while maintaining a low-profile fixation system. Their design allows stable fixation with minimal hardware bulk and may reduce unwanted transverse displacement of fracture segments.
conventional platesDevice
Conventional plate-and-screw fixation has long been considered the standard treatment modality for anterior mandibular fractures. However, plate fixation may induce transverse mandibular widening or narrowing due to plate adaptation forces, screw placement, and limited interfragmentary compression
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Not described Receives: Device: headless compression screw |
| control | Active comparator | Not described Receives: Device: conventional plates |
What is being measured
The primary outcome is the main question the study is designed to answer.
intercondylar angle
Measured: 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
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Samy Ismail, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826403
- Sponsor's protocol ID
- 2911
- Acronym
- fracture
- 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 Evaluation of Condylar Position Following Anterior Mandibular Fracture Fixation Using Conventional Plates Versus Headless Compression Screws: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07826403
- Acronym / sponsor ID
- fracture / 2911
- Conditions
- Anterior Mandibular Fracture
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 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.
This study compares two methods for fixing fractures of the front part of the lower jaw:
Conventional plates and screws Headless compression screws
Patients are randomly assigned to one of the two treatment groups. Researchers will use imaging to see whether either method causes a significant change in the position of the mandibular condyles, which are the parts of the jaw that connect to the jaw joints.
Why it matters: Proper condylar position is important for normal jaw movement, chewing, and overall TMJ function.
Main goal: To determine whether conventional plates or headless compression screws provide better preservation of condylar position after surgery.
The study may help surgeons choose the most appropriate fixation technique for patients with anterior mandibular fractures.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Device: headless compression screw |
| control | Active comparator | Device: conventional 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 of age from 18 years or older, irrespective of the gender.
- Recent single isolated anterior mandibular fracture (symphyseal or parasymphyseal) indicated for open reduction and internal fixation.
- Dentate or partially dentate patients.
Key exclusion criteria (4 listed)
- Comminuted fractures.
- Medically compromised patients contradicting surgical intervention under general anaesthesia.
- Patients younger than 18 years.
- Completely edentulous patients.
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 screwHeadless compression screws provide interfragmentary compression along the long axis of the mandible while maintaining a low-profile fixation system. Their design allows stable fixation with minimal hardware bulk and may reduce unwanted transverse displacement of fracture segments. | Device | intervention |
| conventional platesConventional plate-and-screw fixation has long been considered the standard treatment modality for anterior mandibular fractures. However, plate fixation may induce transverse mandibular widening or narrowing due to plate adaptation forces, screw placement, and limited interfragmentary compression | Device | control |
Primary outcome
intercondylar angle
Time frame: 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
Comparing Bone Healing in Jaw Fractures Fixed With Herbert Screws Versus 3D Miniplates
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 conventional 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 4 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 ahmed mohamed samy (01222622431, ahmed.samy@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intercondylar angle (time frame: 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.