Mandibular FracturesNCT06323122
A Comparative Study Between Three Different Plating Techniques in Management of Mandibular Parasymphyseal Fractures.
An observational study of Mandibular Fractures, run by October 6 University at 1 site in Egypt.
Trial summary
The main goal in management of mandibular fractures is to restore the pre-injury form and function, with the least disability and shortest recovery period. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Mandibular Fractures
- What is being tested?
- 2.0 miniplates, 2.3 high profile miniplates and 3D miniplates
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Dec 2023
- Phase
- Observational
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: patients who had suffered from a recent mandibular fractures in the symphyseal or parasymphyseal region which required Open Reduction with Internal Fixation (ORIF)
Who may be able to join
- Patients with symphyseal/ parasymphyseal mandibular fracture.
- Patients presenting within 7 days of trauma.
Who cannot join
- Associated fractures that could affect occlusion or dimensions
- Medically compromised patients who are unfit for management under General Anesthesia
- Patients with gross infection at the site of fracture
- Patients not willing to return for follow-up
- Patients with associated bone pathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study Between Three Different Plating Techniques in Management of Mandibular Parasymphyseal Fractures. A Retrospective Study
The main goal in management of mandibular fractures is to restore the pre-injury form and function, with the least disability and shortest recovery period.
Read the detailed description
Currently there are a diversity of metallic hardware used for fixation of jaw fractures. However, the proper selection of the suitable technique is still a matter of debate.
The aim of the current study was to compare between the effect of two miniplates, 2.3 high profile Miniplates and three dimensional (3D) Miniplates for internal fixation treatment of mandibular para-symphyseal fractures.
- Conditions
- Mandibular Fractures
- Being tested
- 2.0 miniplates, 2.3 high profile miniplates, 3D miniplates
- Keywords
- parasymphyseal, mandibular fracture, internal fixation, miniplates, 3D miniplate
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2.0 miniplatesDevice
2.0 miniplates
2.3 high profile miniplatesDevice
2.3 high profile miniplates
3D miniplatesDevice
3D miniplates
| Study group | Role | What they receive |
|---|---|---|
| group (I) | ORIF was done using two 2.0 miniplates Receives: Device: 2.0 miniplates | |
| Group II | ORIF was done using 2.3 high profile miniplates Receives: Device: 2.3 high profile miniplates | |
| Group III | ORIF was done using 3D miniplates. Receives: Device: 3D miniplates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgery Time
measure the time of surgery from incision till closure with minutes
Measured: intraoperative
Secondary outcomes (2)
complication
record the surgical complication operative and postoperative
Measured: 6 months
fracture stability
measure fracture stability from radiographs
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start1 Jan 2021
- Primary completion1 Oct 2023
- Study completion1 Dec 2023
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 Mandibular FracturesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nermine Ramadan Mahmoud, October 6 University
- Investigators
- Nermine Ramadan Mahmoud, PhD, Principal investigator, Associated Professor of oral and maxillofacial surgery, Oral Surgery Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323122
- Sponsor's protocol ID
- Plating Techniques 2023
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hu W, Agrawal M, Thadani S, Mukul SK, Sood R, Patel A, Dhanak R, Tailor S. Comparative evaluation of a single 2.0-mm AO locking reconstruction plate with conventional miniplate osteosynthesis for treatment of linear non-comminuted fractures of symphysis and parasymphsis region of the mandible. J Stomatol Oral Maxillofac Surg. 2019 Feb;120(1):11-15. doi: 10.1016/j.jormas.2018.10.002. Epub 2018 Oct 26.
PubMed 30739640
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Three Different Plating Techniques in Management of Mandibular Parasymphyseal Fractures. A Retrospective Study
- ClinicalTrials.gov ID
- NCT06323122
- Acronym / sponsor ID
- Plating Techniques 2023
- Conditions
- Mandibular Fractures
- Keywords
- parasymphyseal, mandibular fracture, internal fixation, miniplates, 3D miniplate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 21 Mar 2024 (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 main goal in management of mandibular fractures is to restore the pre-injury form and function, with the least disability and shortest recovery period.
Detailed description
Currently there are a diversity of metallic hardware used for fixation of jaw fractures. However, the proper selection of the suitable technique is still a matter of debate.
The aim of the current study was to compare between the effect of two miniplates, 2.3 high profile Miniplates and three dimensional (3D) Miniplates for internal fixation treatment of mandibular para-symphyseal fractures.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group (I) | – | Device: 2.0 miniplatesORIF was done using two 2.0 miniplates |
| Group II | – | Device: 2.3 high profile miniplatesORIF was done using 2.3 high profile miniplates |
| Group III | – | Device: 3D miniplatesORIF was done using 3D miniplates. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients who had suffered from a recent mandibular fractures in the symphyseal or parasymphyseal region which required Open Reduction with Internal Fixation (ORIF)
Key inclusion criteria (2 listed)
- Patients with symphyseal/ parasymphyseal mandibular fracture.
- Patients presenting within 7 days of trauma.
Key exclusion criteria (5 listed)
- Associated fractures that could affect occlusion or dimensions
- Medically compromised patients who are unfit for management under General Anesthesia
- Patients with gross infection at the site of fracture
- Patients not willing to return for follow-up
- Patients with associated bone pathology
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 |
|---|---|---|
| 2.0 miniplates2.0 miniplates | Device | group (I) |
| 2.3 high profile miniplates2.3 high profile miniplates | Device | Group II |
| 3D miniplates3D miniplates | Device | Group III |
Primary outcome
Surgery Time
Time frame: intraoperative
measure the time of surgery from incision till closure with minutes
2 secondary outcomes
complication
Time frame: 6 months
fracture stability
Time frame: 6 months
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 21 Mar 2024.
- Background: PubMed 30739640Hu W, Agrawal M, Thadani S, Mukul SK, Sood R, Patel A, Dhanak R, Tailor S. Comparative evaluation of a single 2.0-mm AO locking reconstruction plate with conventional miniplate osteosynthesis for treatment of linear non-comminuted fractures of symphysis and parasymphsis region of the mandible. J Stomatol Oral Maxillofac Surg. 2019 Feb;120(1):11-15. doi: 10.1016/j.jormas.2018.10.002. Epub 2018 Oct 26.
- 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.
Nermine Ramadan Mahmoud, PhD principal investigator
Associated Professor of oral and maxillofacial surgery, Oral Surgery Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mandibular Fractures, run by October 6 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 5 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 21 Mar 2024. 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?
Surgery Time (time frame: intraoperative). 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 NCT06323122, 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 21 Mar 2024.