Mandibular FracturesNCT06349135
Assessment of Serum Concentration of Interleukin-17 and Osteoprotegerin in Response to Surgical Trauma Induced by Management of Mandibular Fractures Via Intraoral Versus Extraoral Approaches: Prospective Cohort Study
An observational study of Mandibular Fractures, run by Aya Ayman Ahmed.
Trial summary
Assessment of Serum Concentration of Interleukin-17 and Osteoprotegerin in Response to Surgical Trauma Induced by Management of Mandibular Fractures via Intraoral Versus Extraoral Approaches: Prospective Cohort Study Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Mandibular Fractures
- What is being tested?
- Open Reduction & Internal Fixation
- Type of treatment
- Surgery or procedure
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2024to 15 Dec 2025
- How long will I take part?
- 6 Weeks
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with single mandibular fracture.
Who may be able to join
- Single mandibular fracture.
- ORIF is done by two plates fixation with titanium plates and screws.
- Age (18-50 years).
- Recent fracture (less than 2 weeks).
Who cannot join
- Pathological fractures.
- Medical compromised patient.
- Presence of concomitant injuries.
- Patients receive radiotherapy.
- Patients receive blood transfusion.
About this study
Assessment of Serum Concentration of Interleukin-17 and Osteoprotegerin in Response to Surgical Trauma Induced by Management of Mandibular Fractures via Intraoral Versus Extraoral Approaches: Prospective Cohort Study
- Conditions
- Mandibular Fractures
- Being tested
- Open Reduction & 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 & Internal FixationProcedure or surgery
Open Reduction \& Internal Fixation of Mandibular fracture either through intraoral or extraoral approaches.
| Study group | Role | What they receive |
|---|---|---|
| Management of Mandibular Fractures via Intraoral approach. | Management of Mandibular Fractures via Intraoral approach. Receives: Procedure: Open Reduction & Internal Fixation | |
| Management of Mandibular Fractures via Extraoral approach. | Management of Mandibular Fractures via Extraoral approach. Receives: Procedure: Open Reduction & Internal Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-17
Interleukin-17
Measured: 6- weeks
OPG
Osteoprotegerin
Measured: 6- weeks
Secondary outcomes (2)
Blood Loss
Measured: in operation room
Operative time
Measured: Operative time in minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start15 Apr 2024 (estimated)
- Primary completion15 Apr 2024 (estimated)
- Study completion15 Dec 2025 (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
- Prospective
- Enrolment
- 2 participants (estimated)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Aya Ayman Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aya Ayman Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349135
- Sponsor's protocol ID
- A.Ayman OMFS
- Status last verified
- Mar 2024
- First submitted
- 31 Mar 2024
- Last updated
- 5 Apr 2024
- 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 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Serum Concentration of Interleukin-17 and Osteoprotegerin in Response to Surgical Trauma Induced by Management of Mandibular Fractures Via Intraoral Versus Extraoral Approaches: Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06349135
- Acronym / sponsor ID
- A.Ayman OMFS
- Conditions
- Mandibular Fractures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Aya Ayman AhmedUniversity, hospital or other
- Study start
- 15 Apr 2024 (estimated)
- Primary completion
- 15 Apr 2024 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 5 Apr 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.
Assessment of Serum Concentration of Interleukin-17 and Osteoprotegerin in Response to Surgical Trauma Induced by Management of Mandibular Fractures via Intraoral Versus Extraoral Approaches: Prospective Cohort Study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Management of Mandibular Fractures via Intraoral approach. | – | Procedure: Open Reduction & Internal FixationManagement of Mandibular Fractures via Intraoral approach. |
| Management of Mandibular Fractures via Extraoral approach. | – | Procedure: Open Reduction & Internal FixationManagement of Mandibular Fractures via Extraoral approach. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with single mandibular fracture.
Key inclusion criteria (4 listed)
- Single mandibular fracture.
- ORIF is done by two plates fixation with titanium plates and screws.
- Age (18-50 years).
- Recent fracture (less than 2 weeks).
Key exclusion criteria (5 listed)
- Pathological fractures.
- Medical compromised patient.
- Presence of concomitant injuries.
- Patients receive radiotherapy.
- Patients receive blood transfusion.
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 & Internal FixationOpen Reduction \& Internal Fixation of Mandibular fracture either through intraoral or extraoral approaches. | Procedure or surgery | Management of Mandibular Fractures via Extraoral approach., Management of Mandibular Fractures via Intraoral approach. |
Primary outcome
IL-17
Time frame: 6- weeks
Interleukin-17
OPG
Time frame: 6- weeks
Osteoprotegerin
2 secondary outcomes
Blood Loss
Time frame: in operation room
Operative time
Time frame: Operative time in minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
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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?
An observational study of Mandibular Fractures, run by Aya Ayman Ahmed.
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 4 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: status not confirmed, as of the sponsor's last update on 5 Apr 2024. 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?
IL-17 (time frame: 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?
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 Apr 2024.