Mandible FractureNCT07103590
Sagittal Split Plate Versus Two Miniplates in the Treatment of Mandibular Angle Fractures
A study testing single Sagittal Split plate and two conventional miniplates in people with Mandible Fracture, run by Alexandria University at 1 site in Egypt.
Trial summary
Mandibular fractures are the second most common maxillofacial fracture after nasal bone fracture. As a result, a lot of research work has gone into improving treatment methods for these fractures including, reduction of immobilization period and enhancement of rigid fixation. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Mandible Fracture
- What is being tested?
- single Sagittal Split plate and two conventional miniplates
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jul 2025to 1 Dec 2025
- 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients suffering from recent, uninfected angle mandibular fracture.
- Fracture that demands open reduction and internal fixation.
Who cannot join
- Medically compromised patients contradicting the operation.
- Existence of infection at the fracture line.
- Pathological fracture.
- An old fracture.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University
Alexandria
Peter Naeem El Masry, BDS, peternaderelmasry@gmail.com
Peter Naeem El Masry, BDS
About this study
Official title: New Design Sagittal Split Plate Versus Two Miniplates in the Treatment of Mandibular Angle Fractures (Randomized Controlled Clinical Trial)
Mandibular fractures are the second most common maxillofacial fracture after nasal bone fracture. As a result, a lot of research work has gone into improving treatment methods for these fractures including, reduction of immobilization period and enhancement of rigid fixation. One of these modalities is the use of Sagittal Split plate at the angle of the mandible.
- Conditions
- Mandible Fracture
- Being tested
- single Sagittal Split plate, two conventional miniplates
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single Sagittal Split plateProcedure or surgery
patients will be treated using a single Sagittal Split plate at the neutral zone of mandible
two conventional miniplatesProcedure or surgery
patients will be treated using two conventional miniplates according to Champy's osteosynthesis lines.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Not described Receives: Procedure: single Sagittal Split plate |
| Conventional Group | Active comparator | Not described Receives: Procedure: two conventional miniplates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain scores
Will be assessed through a 10-point Visual Analogue Scale (VAS) (34). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe).
Measured: baseline, 24 hours, 1 week, and 6 weeks
Change in Maximal Inter-Incisal Mouth
Using a millimeter ruler to measure maximal inter-incisal mouth opening
Measured: baseline, 24 hours, 1 week, and 6 weeks
Secondary outcomes (2)
postoperative infection
observation for any manifestations of wound healing disturbance
Measured: 24 hours, 1 week, and 6 weeks
change in bone density
Immediate CT (T0) scan will be done and then another CT (T1) will be taken at 12th week to estimate the mean bone density at the fracture line in comparison with the immediate postoperative scan
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start16 Jul 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mandible FractureStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103590
- Sponsor's protocol ID
- 1026-1/2025
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El-Masry PN, Mohamed NS, Saber ME. A novel plate design versus two conventional miniplates for treatment of mandibular angle fractures (a pilot randomized controlled clinical trial). BMC Oral Health. 2026 May 9;26(1):867. doi: 10.1186/s12903-026-08474-5.
PubMed 42104343
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Design Sagittal Split Plate Versus Two Miniplates in the Treatment of Mandibular Angle Fractures (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07103590
- Acronym / sponsor ID
- 1026-1/2025
- Conditions
- Mandible Fracture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 5 Aug 2025 (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.
Mandibular fractures are the second most common maxillofacial fracture after nasal bone fracture. As a result, a lot of research work has gone into improving treatment methods for these fractures including, reduction of immobilization period and enhancement of rigid fixation. One of these modalities is the use of Sagittal Split plate at the angle of the mandible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Procedure: single Sagittal Split plate |
| Conventional Group | Active comparator | Procedure: two conventional miniplates |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients suffering from recent, uninfected angle mandibular fracture.
- Fracture that demands open reduction and internal fixation.
Key exclusion criteria (4 listed)
- Medically compromised patients contradicting the operation.
- Existence of infection at the fracture line.
- Pathological fracture.
- An old fracture.
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 |
|---|---|---|
| single Sagittal Split platepatients will be treated using a single Sagittal Split plate at the neutral zone of mandible | Procedure or surgery | Test Group |
| two conventional miniplatespatients will be treated using two conventional miniplates according to Champy's osteosynthesis lines. | Procedure or surgery | Conventional Group |
Primary outcome
Change in pain scores
Time frame: baseline, 24 hours, 1 week, and 6 weeks
Will be assessed through a 10-point Visual Analogue Scale (VAS) (34). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe).
Change in Maximal Inter-Incisal Mouth
Time frame: baseline, 24 hours, 1 week, and 6 weeks
Using a millimeter ruler to measure maximal inter-incisal mouth opening
2 secondary outcomes
postoperative infection
Time frame: 24 hours, 1 week, and 6 weeks
change in bone density
Time frame: baseline and 12 weeks
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 5 Aug 2025.
- Derived from this study: PubMed 42104343El-Masry PN, Mohamed NS, Saber ME. A novel plate design versus two conventional miniplates for treatment of mandibular angle fractures (a pilot randomized controlled clinical trial). BMC Oral Health. 2026 May 9;26(1):867. doi: 10.1186/s12903-026-08474-5.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single Sagittal Split plate and two conventional miniplates in people with Mandible Fracture, run by Alexandria 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 2 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: looking for participants now, as of the sponsor's last update on 5 Aug 2025. 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?
Contact Peter Naeem El Masry, BDS (0 12 87142534 ext. +2, peternaderelmasry@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain scores (time frame: baseline, 24 hours, 1 week, and 6 weeks). 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?
On the ClinicalTrials.gov record for NCT07103590, which also lists 1 linked publication.
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 5 Aug 2025.