Mandible FractureNCT03747666
Single Locking Miniplate and Two Non-locking Miniplates in the Management of Parasymphyseal Fracture
A study testing 2.0 single locking miniplates in people with Mandible Fracture, run by Cairo University.
Trial summary
Evaluating the biting force after management of parasymphyseal fracture in patients with two-line mandibular fractures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mandible Fracture
- What is being tested?
- 2.0 single locking miniplates
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2019to Nov 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Contra-lateral unfavorable non-comminuted simple or compound mandibular fracture in the parasymphyseal and angle regions.
- Fractures amenable to treatment using intra oral approach.
Who cannot join
- Medically compromised patients who are unfit for the procedure under general anesthesia.
- Patients with comminuted fractures.
- Patients with history of occlusion disturbances or skeletal malocclusion.
- Patients with insufficient dentition to reproduce occlusion.
About this study
Official title: Evaluating Masticatory Biting Force After Using Single Locking Miniplate Versus Two Non-locking Miniplates in the Management of Parasymphyseal Fracture in Patients With Two-line Mandibular Fractures
Evaluating the biting force after management of parasymphyseal fracture in patients with two-line mandibular fractures.
Read the detailed description
Evaluating the biting force after using 2.0 mm single locking miniplate versus 2.0 mm two conventional non-locking miniplates in the management of parasymphyseal fracture in patients with two-line mandibular fractures.
- Conditions
- Mandible Fracture
- Being tested
- 2.0 single locking 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.
2.0 single locking miniplatesProcedure or surgery
The fractured segments in the parasymphyseal region will be fixed using 2.0 single locking miniplates placed on the inferior border of the mandible.
| Study group | Role | What they receive |
|---|---|---|
| Locking miniplate | Experimental | The fractured segments in the parasymphyseal region will be fixed using 2.0 single locking miniplates and the fractured segments of the angle will be fixed conventionally using 2.0 single non-locking miniplate placed on the external oblique ridge. Receives: Procedure: 2.0 single locking miniplates |
| Non-locking miniplates | Experimental | The fractured segments in the parasymphyseal region will be fixed using 2.0 two non-locking miniplates and the fractured segments of the angle will be fixed conventionally using 2.0 single non-locking miniplate placed on the external oblique ridge. Receives: Procedure: 2.0 single locking miniplates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biting force
Biting force will be measured using occlusal biting force meter (Higher biting force record is better)
Measured: 6 months
Secondary outcomes (7)
Stability of fractured segments
Bi-manual manipulation (Binary Yes/No)
Measured: 6 weeks
Pain intensity
Visual analog scale (0-10) 0=No pain \& 10=Severe pain
Measured: 10 days
Occlusion
Clinical examination (Intact/Deranged)
Measured: 6 months
Infection
Clinical examination (Present/Absent)
Measured: 6 months
Hardware failure
Clinical examination (Present/Absent)
Measured: 6 months
Paraesthesia
Observation/Contact detection/Pin-brick nociception (0-10) 0=No sensation \& 10= Normal sensation
Measured: 6 months
Wound dehiscence
Clinical examination (Present/Absent)
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 posted20 Nov 2018
- Study startNov 2019 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandible 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Abdelkader Hussein, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747666
- Sponsor's protocol ID
- 30101980
- Status last verified
- Feb 2019
- First submitted
- 12 Nov 2018
- Last updated
- 19 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Masticatory Biting Force After Using Single Locking Miniplate Versus Two Non-locking Miniplates in the Management of Parasymphyseal Fracture in Patients With Two-line Mandibular Fractures
- ClinicalTrials.gov ID
- NCT03747666
- Acronym / sponsor ID
- 30101980
- Conditions
- Mandible Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2019 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 20 Nov 2018 (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.
Evaluating the biting force after management of parasymphyseal fracture in patients with two-line mandibular fractures.
Detailed description
Evaluating the biting force after using 2.0 mm single locking miniplate versus 2.0 mm two conventional non-locking miniplates in the management of parasymphyseal fracture in patients with two-line mandibular fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Locking miniplate | Experimental | Procedure: 2.0 single locking miniplatesThe fractured segments in the parasymphyseal region will be fixed using 2.0 single locking miniplates and the fractured segments of the angle will be fixed conventionally using 2.0 single non-locking miniplate placed on the external oblique ridge. |
| Non-locking miniplates | Experimental | Procedure: 2.0 single locking miniplatesThe fractured segments in the parasymphyseal region will be fixed using 2.0 two non-locking miniplates and the fractured segments of the angle will be fixed conventionally using 2.0 single non-locking miniplate placed on the external oblique ridge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Contra-lateral unfavorable non-comminuted simple or compound mandibular fracture in the parasymphyseal and angle regions.
- Fractures amenable to treatment using intra oral approach.
Key exclusion criteria (4 listed)
- Medically compromised patients who are unfit for the procedure under general anesthesia.
- Patients with comminuted fractures.
- Patients with history of occlusion disturbances or skeletal malocclusion.
- Patients with insufficient dentition to reproduce occlusion.
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 single locking miniplatesThe fractured segments in the parasymphyseal region will be fixed using 2.0 single locking miniplates placed on the inferior border of the mandible. | Procedure or surgery | Locking miniplate, Non-locking miniplates |
Primary outcome
Biting force
Time frame: 6 months
Biting force will be measured using occlusal biting force meter (Higher biting force record is better)
7 secondary outcomes
Stability of fractured segments
Time frame: 6 weeks
Pain intensity
Time frame: 10 days
Occlusion
Time frame: 6 months
Infection
Time frame: 6 months
Hardware failure
Time frame: 6 months
Paraesthesia
Time frame: 6 months
Wound dehiscence
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing 2.0 single locking miniplates in people with Mandible 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 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: status not confirmed, as of the sponsor's last update on 19 Feb 2019. 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?
Results are not available in the source record.
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?
Biting force (time frame: 6 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 19 Feb 2019.