Mandibular FracturesNCT07736430
Evaluation of Pin Buckle Bone Plates for Management of Anterior Mandibular Fractures
A study testing Pin Buckle Bone Plate and Conventional Titanium Miniplates in people with Mandibular Fractures and Symphysis Fractures, run by Suez Canal University at 1 site in Egypt.
Trial summary
This randomized clinical study aims to evaluate the clinical and radiographic outcomes of a novel Pin Buckle bone plate compared with conventional two-miniplate fixation for the management of anterior mandibular (symphysis and parasymphysis) fractures. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Mandibular Fractures, Symphysis Fractures, Parasymphysis Fractures
- What is being tested?
- Pin Buckle Bone Plate and Conventional Titanium Miniplates
- 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
- 11 Jun 2025to 2 May 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult patients aged 18 to 55 years old.
- Adult patients of either gender.
- Patients who are free from any systemic disease (ASA I).
- Patients suffering from recent, simple and single symphyseal or parasymphyseal mandibular fractures.
- Unfavorable fractures requiring open reduction and internal fixation.
- Patients willing to attend all postoperative follow-up visits.
Who cannot join
- Pregnant or lactating women.
- Patients with associated maxillofacial injuries that may interfere with study outcomes.
- Patients with comminuted mandibular fractures.
- Patients with infected fractures.
- Patients with pathological fractures.
- Previously failed fixation of symphyseal or parasymphyseal fractures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Pin Buckle Bone Plates for Management of Anterior Mandibular Fractures: A Randomized Study
This randomized clinical study aims to evaluate the clinical and radiographic outcomes of a novel Pin Buckle bone plate compared with conventional two-miniplate fixation for the management of anterior mandibular (symphysis and parasymphysis) fractures. Twenty adult patients requiring open reduction and internal fixation will be randomly allocated into two equal groups. The study group will receive fixation using the Pin Buckle bone plate, while the control group will be treated using conventional titanium miniplates.
Clinical outcomes including pain, edema, wound healing, and postoperative complications will be evaluated during the postoperative follow-up period. Radiographic assessment using computed tomography (CT) will be performed immediately after surgery and at 6 months to evaluate bone density. The study seeks to determine whether the Pin Buckle bone plate provides improved postoperative healing and functional outcomes compared with conventional miniplate fixation.
- Being tested
- Pin Buckle Bone Plate, Conventional Titanium Miniplates
- Keywords
- Anterior mandibular fracture, Parasymphysis fracture, Symphysis fracture, Pin Buckle bone plate, Conventional miniplate, Internal fixation, Maxillofacial trauma, Bone plate, Computed tomography, Randomized clinical trial, Open reduction and internal fixation
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pin Buckle Bone PlateDevice
A titanium Pin Buckle bone plate used for internal fixation of anterior mandibular fractures following open reduction.
Conventional Titanium MiniplatesDevice
Conventional titanium miniplates used for internal fixation of anterior mandibular fractures following open reduction according to Champy's principles.
| Study group | Role | What they receive |
|---|---|---|
| Pin Buckle Bone Plate | Experimental | Participants underwent open reduction and internal fixation of anterior mandibular (symphysis or parasymphysis) fractures using the Pin Buckle bone plate. Clinical and radiographic outcomes were evaluated during the postoperative follow-up period. Receives: Device: Pin Buckle Bone Plate |
| Conventional Two-Miniplate Fixation | Active comparator | Participants underwent open reduction and internal fixation of anterior mandibular (symphysis or parasymphysis) fractures using conventional titanium two-miniplate fixation according to Champy's principles. Clinical and radiographic outcomes were evaluated during the postoperative follow-up period. Receives: Device: Conventional Titanium Miniplates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Bone Density
Bone density at the fracture site was measured in Hounsfield Units (HU) on multislice CT using standardized regions of interest to evaluate osseous healing.
Measured: Preoperative, immediately postoperative and after 6 months
Wound Healing
Wound healing was assessed clinically using the Southampton Wound Assessment Scale, which evaluates postoperative wound healing based on the presence and severity of normal healing, erythema, bruising, discharge, wound dehiscence, and infection. Higher grades indicate poorer wound healing.
Measured: Day 1, Day 7, and Day 14
Secondary outcomes (2)
Postoperative Pain
Pain intensity was assessed using a 10-cm Visual Analogue Scale (VAS), where 0 indicated no pain and 10 indicated the worst pain imaginable.
Measured: Day 1, Day 7, and Day 14
Postoperative Edema
Facial edema was evaluated clinically by visual inspection and palpation and categorized as none, low-grade, intermediate-grade, or high-grade according to the severity of facial swelling.
Measured: Day 1, Day 7, and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start11 Jun 2025
- Primary completion12 Apr 2026
- Study completion2 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular FracturesStudies of the same condition, open and under way.
- More trials run by Suez Canal 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
- Model description
- Participants were randomly assigned in a 1:1 ratio to receive fracture fixation using either the Pin Buckle bone plate (study group) or conventional two-miniplate fixation (control group). Outcomes were compared between the two parallel groups during the postoperative follow-up period.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed abdelnaby, Suez Canal University
- Investigators
- Mohamed Said Hamed, Professor, Study chair, Professor of Oral and Maxillofacial Surgery - Faculty of Dentistry - Suez Canal UniversityAhmed Abdelmohsen Younis, Associate Professor, Study director, Associate Professor of Oral and Maxillofacial Surgery - Faculty of Dentistry - Suez Canal UniversityMohamed Abdelnaby, B.S.D, Principal investigator, Resident Zagazig University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736430
- Sponsor's protocol ID
- 968/2025
- Status last verified
- Jul 2026
- First submitted
- 25 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Pin Buckle Bone Plates for Management of Anterior Mandibular Fractures: A Randomized Study
- ClinicalTrials.gov ID
- NCT07736430
- Acronym / sponsor ID
- 968/2025
- Keywords
- Anterior mandibular fracture, Parasymphysis fracture, Symphysis fracture, Pin Buckle bone plate, Conventional miniplate, Internal fixation, Maxillofacial trauma, Bone plate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 12 Apr 2026 (actual)
- Study completion
- 2 May 2026 (actual)
- First posted
- 30 Jul 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 randomized clinical study aims to evaluate the clinical and radiographic outcomes of a novel Pin Buckle bone plate compared with conventional two-miniplate fixation for the management of anterior mandibular (symphysis and parasymphysis) fractures. Twenty adult patients requiring open reduction and internal fixation will be randomly allocated into two equal groups. The study group will receive fixation using the Pin Buckle bone plate, while the control group will be treated using conventional titanium miniplates.
Clinical outcomes including pain, edema, wound healing, and postoperative complications will be evaluated during the postoperative follow-up period. Radiographic assessment using computed tomography (CT) will be performed immediately after surgery and at 6 months to evaluate bone density. The study seeks to determine whether the Pin Buckle bone plate provides improved postoperative healing and functional outcomes compared with conventional miniplate fixation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to receive fracture fixation using either the Pin Buckle bone plate (study group) or conventional two-miniplate fixation (control group). Outcomes were compared between the two parallel groups during the postoperative follow-up period.
| Arm | Type | Receives |
|---|---|---|
| Pin Buckle Bone Plate | Experimental | Device: Pin Buckle Bone PlateParticipants underwent open reduction and internal fixation of anterior mandibular (symphysis or parasymphysis) fractures using the Pin Buckle bone plate. Clinical and radiographic outcomes were evaluated during the postoperative follow-up period. |
| Conventional Two-Miniplate Fixation | Active comparator | Device: Conventional Titanium MiniplatesParticipants underwent open reduction and internal fixation of anterior mandibular (symphysis or parasymphysis) fractures using conventional titanium two-miniplate fixation according to Champy's principles. Clinical and radiographic outcomes were evaluated during the postoperative follow-up period. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adult patients aged 18 to 55 years old.
- Adult patients of either gender.
- Patients who are free from any systemic disease (ASA I).
- Patients suffering from recent, simple and single symphyseal or parasymphyseal mandibular fractures.
- Unfavorable fractures requiring open reduction and internal fixation.
Key exclusion criteria (6 listed)
- Pregnant or lactating women.
- Patients with associated maxillofacial injuries that may interfere with study outcomes.
- Patients with comminuted mandibular fractures.
- Patients with infected fractures.
- Patients with pathological fractures.
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 |
|---|---|---|
| Pin Buckle Bone PlateA titanium Pin Buckle bone plate used for internal fixation of anterior mandibular fractures following open reduction. | Device | Pin Buckle Bone Plate |
| Conventional Titanium MiniplatesConventional titanium miniplates used for internal fixation of anterior mandibular fractures following open reduction according to Champy's principles. | Device | Conventional Two-Miniplate Fixation |
Primary outcome
Radiographic Bone Density
Time frame: Preoperative, immediately postoperative and after 6 months
Bone density at the fracture site was measured in Hounsfield Units (HU) on multislice CT using standardized regions of interest to evaluate osseous healing.
Wound Healing
Time frame: Day 1, Day 7, and Day 14
Wound healing was assessed clinically using the Southampton Wound Assessment Scale, which evaluates postoperative wound healing based on the presence and severity of normal healing, erythema, bruising, discharge, wound dehiscence, and infection. Higher grades indicate poorer wound healing.
2 secondary outcomes
Postoperative Pain
Time frame: Day 1, Day 7, and Day 14
Postoperative Edema
Time frame: Day 1, Day 7, and Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 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.
Mohamed Said Hamed, Professor study chair
Professor of Oral and Maxillofacial Surgery - Faculty of Dentistry - Suez Canal University
Ahmed Abdelmohsen Younis, Associate Professor study director
Associate Professor of Oral and Maxillofacial Surgery - Faculty of Dentistry - Suez Canal University
Mohamed Abdelnaby, B.S.D principal investigator
Resident Zagazig University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pin Buckle Bone Plate and Conventional Titanium Miniplates in people with Mandibular Fractures and Symphysis Fractures, run by Suez Canal 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 6 inclusion and 6 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 30 Jul 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?
Radiographic Bone Density (time frame: Preoperative, immediately postoperative and after 6 months). The study lists 2 primary outcomes in all. 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 30 Jul 2026.