Mandibular FracturesNCT04396054
Comparison of Double Y-shaped Plates and Lag Screws in Fixation of Anterior Mandibular Fractures
A study testing Lag Screws and double Y-shaped plates in people with Mandibular Fractures, run by Lydia Nabil at 1 site in Egypt.
Trial summary
This study is a prospective randomized controlled clinical trial. It was performed on sixteen patients with anterior mandibular fractures, to compare Double Y-shaped plates and Lag Screws in fracture fixation from clinical and radiographic perspectives. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Mandibular Fractures
- What is being tested?
- Lag Screws and double Y-shaped plates
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Sep 2019to 20 Feb 2020
- 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 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of both genders
- with age ranging from 25 to 45 years,
- suffering from anterior fractures of the mandible (symphyseal or parasymphyseal)
Who cannot join
- old fractures,
- infected fractures
- comminuted fractures
Trial locations and contacts
1 site in 1 country.
About this study
This study is a prospective randomized controlled clinical trial. It was performed on sixteen patients with anterior mandibular fractures, to compare Double Y-shaped plates and Lag Screws in fracture fixation from clinical and radiographic perspectives.
Read the detailed description
This study is a prospective randomized controlled clinical trial. It was performed on sixteen patients with anterior mandibular fractures, selected from those admitted to the Emergency Department of Alexandria University Hospital. Ethical approval for the study was obtained from the regional Ethical Review Board of the Faculty of Dentistry, Alexandria University. A written informed consent was signed by patients before the operation.
Patients were divided equally into two groups, each consisting of eight patients. Assignment of each patient into one of either group was done using computer random numbers.
Group 1: underwent open reduction and internal fixation using two lag screws. Group 2: underwent open reduction and internal fixation using double Y-shaped plates.
- Conditions
- Mandibular Fractures
- Being tested
- Lag Screws, double Y-shaped plates
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lag ScrewsDevice
Method of internal fixation
double Y-shaped platesDevice
Method of internal fixation
| Study group | Role | What they receive |
|---|---|---|
| Lag Screws | Active comparator | Group 1: underwent open reduction and internal fixation using two lag screws. Receives: Device: Lag Screws |
| Double Y-shaped plates | Active comparator | Group 2: underwent open reduction and internal fixation using double Y-shaped plates. Receives: Device: double Y-shaped plates |
What is being measured
The primary outcome is the main question the study is designed to answer.
progress of fracture healing in the postoperative period
Measurement of bone density in the fracture line using CBCT at 6 points and calculation of mean bone density
Measured: after 6 months
Sensory nerve function using dental probe to assess sensory changes along mental nerve distribution and comparing it to the contralateral side
Detection of nerve injury by examining sensory nerve function using dental probe to assess sensory changes along mental nerve distribution and comparing it to the contralateral side
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start3 Sep 2019
- Primary completion20 Feb 2020
- Study completion20 Feb 2020
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.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lydia Nabil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lydia Nabil, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396054
- Sponsor's protocol ID
- UAlexandriaDentSurg1
- Status last verified
- May 2020
- First submitted
- 9 May 2020
- Last updated
- 20 May 2020
- 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 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Double Y-shaped Plates and Lag Screws in Fixation of Anterior Mandibular Fractures
- ClinicalTrials.gov ID
- NCT04396054
- Acronym / sponsor ID
- UAlexandriaDentSurg1
- Conditions
- Mandibular Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Lydia NabilUniversity, hospital or other
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 20 May 2020 (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 is a prospective randomized controlled clinical trial. It was performed on sixteen patients with anterior mandibular fractures, to compare Double Y-shaped plates and Lag Screws in fracture fixation from clinical and radiographic perspectives.
Detailed description
This study is a prospective randomized controlled clinical trial. It was performed on sixteen patients with anterior mandibular fractures, selected from those admitted to the Emergency Department of Alexandria University Hospital. Ethical approval for the study was obtained from the regional Ethical Review Board of the Faculty of Dentistry, Alexandria University. A written informed consent was signed by patients before the operation.
Patients were divided equally into two groups, each consisting of eight patients. Assignment of each patient into one of either group was done using computer random numbers.
Group 1: underwent open reduction and internal fixation using two lag screws. Group 2: underwent open reduction and internal fixation using double Y-shaped plates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lag Screws | Active comparator | Device: Lag ScrewsGroup 1: underwent open reduction and internal fixation using two lag screws. |
| Double Y-shaped plates | Active comparator | Device: double Y-shaped platesGroup 2: underwent open reduction and internal fixation using double Y-shaped plates. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients of both genders
- with age ranging from 25 to 45 years,
- suffering from anterior fractures of the mandible (symphyseal or parasymphyseal)
Key exclusion criteria (3 listed)
- old fractures,
- infected fractures
- comminuted 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 |
|---|---|---|
| Lag ScrewsMethod of internal fixation | Device | Lag Screws |
| double Y-shaped platesMethod of internal fixation | Device | Double Y-shaped plates |
Primary outcome
progress of fracture healing in the postoperative period
Time frame: after 6 months
Measurement of bone density in the fracture line using CBCT at 6 points and calculation of mean bone density
Sensory nerve function using dental probe to assess sensory changes along mental nerve distribution and comparing it to the contralateral side
Time frame: up to 6 months
Detection of nerve injury by examining sensory nerve function using dental probe to assess sensory changes along mental nerve distribution and comparing it to the contralateral side
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 20 May 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lag Screws and double Y-shaped plates in people with Mandibular Fractures, run by Lydia Nabil 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 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: finished, as of the sponsor's last update on 20 May 2020. 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?
progress of fracture healing in the postoperative period (time frame: 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 20 May 2020.