Mandibular FracturesNCT04729036
Mandibular Angle Fracture and Interframents Gap
An observational study of Mandibular Fractures, run by Fayoum University at 1 site in Egypt.
Trial summary
Twenty-five patients with mandibular angle fracture were subjected to reduction and fixation through intra-oral open reduction and semi-rigid min plate fixation near the superior border of the mandible at Champy's osteosynthesis line. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mandibular Fractures
- What is being tested?
- open reduction and internal fixation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 1 Feb 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: . All the patients suffered from minimally displaced mandibular angle fracture which needed intervention via reduction and fixation
Who may be able to join
- minimally displaced mandibular angle fracture which needed intervention via reduction and fixation *medically free
Who cannot join
- - Patients with multiple mandibular fractures or patients with concomitant maxillary fracture.
- Patients with severely displaced mandibular angle fracture needing extra-oral open reduction and fixation.
- Medically compromised patients and patients with abnormalities that impair bone healing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interfragmentary Gap Discrepancy After Intraoral One-plate Fixation in Mandibular Angle Fracture
Twenty-five patients with mandibular angle fracture were subjected to reduction and fixation through intra-oral open reduction and semi-rigid min plate fixation near the superior border of the mandible at Champy's osteosynthesis line. The linear inter-fragmentary gap was measured at the inferior border of the mandible after fixation of the fractured bony segments in the final aligned position immediately postoperative on a panoramic radiograph for the mesio-distal plane and a cone beam computed tomography for the bucco-lingual plane to assess any lingual splay. The healing process was clinically followed for 3 months postoperatively for any complications and/or patient complains
- Conditions
- Mandibular Fractures
- Being tested
- 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.
open reduction and internal fixationProcedure or surgery
The same surgical team have treated all the patients through open reduction via an intra-oral mucosal flap under general anesthesia with insertion and fixation of a 4-6 holes 2.0 miniplate and 5 mm screws at the superior border of the mandible at Champy's osteosynthesis line
| Study group | Role | What they receive |
|---|---|---|
| mandibular fracture group | Not described Receives: Procedure: open reduction and internal fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
interfragment gap
measure the mesio-distal plane discrepancy in terms of linear inter-fragmentary gap at the inferior border between the fractured mesial and proximal segments by CT
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start1 Jan 2020
- Primary completion1 Dec 2020
- Study completion1 Feb 2021 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mohsen, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729036
- Sponsor's protocol ID
- 29/12/2019
- Status last verified
- Jan 2021
- First submitted
- 25 Jan 2021
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interfragmentary Gap Discrepancy After Intraoral One-plate Fixation in Mandibular Angle Fracture
- ClinicalTrials.gov ID
- NCT04729036
- Acronym / sponsor ID
- 29/12/2019
- Conditions
- Mandibular Fractures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 28 Jan 2021 (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.
Twenty-five patients with mandibular angle fracture were subjected to reduction and fixation through intra-oral open reduction and semi-rigid min plate fixation near the superior border of the mandible at Champy's osteosynthesis line. The linear inter-fragmentary gap was measured at the inferior border of the mandible after fixation of the fractured bony segments in the final aligned position immediately postoperative on a panoramic radiograph for the mesio-distal plane and a cone beam computed tomography for the bucco-lingual plane to assess any lingual splay. The healing process was clinically followed for 3 months postoperatively for any complications and/or patient complains
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mandibular fracture group | – | Procedure: open reduction and internal fixation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- . All the patients suffered from minimally displaced mandibular angle fracture which needed intervention via reduction and fixation
Key inclusion criteria (1 listed)
- minimally displaced mandibular angle fracture which needed intervention via reduction and fixation *medically free
Key exclusion criteria (3 listed)
- - Patients with multiple mandibular fractures or patients with concomitant maxillary fracture.
- Patients with severely displaced mandibular angle fracture needing extra-oral open reduction and fixation.
- Medically compromised patients and patients with abnormalities that impair bone healing
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 |
|---|---|---|
| open reduction and internal fixationThe same surgical team have treated all the patients through open reduction via an intra-oral mucosal flap under general anesthesia with insertion and fixation of a 4-6 holes 2.0 miniplate and 5 mm screws at the superior border of the mandible at Champy's osteosynthesis line | Procedure or surgery | mandibular fracture group |
Primary outcome
interfragment gap
Time frame: 3 months
measure the mesio-distal plane discrepancy in terms of linear inter-fragmentary gap at the inferior border between the fractured mesial and proximal segments by CT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
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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?
An observational study of Mandibular Fractures, run by Fayoum 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 1 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: status not confirmed, as of the sponsor's last update on 28 Jan 2021. 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?
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?
interfragment gap (time frame: 3 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 28 Jan 2021.