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

March 31, 2024 updated by: Aya Ayman Ahmed
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with single mandibular fracture.

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • Pathological fractures.
  • Medical compromised patient.
  • Presence of concomitant injuries.
  • Patients receive radiotherapy.
  • Patients receive blood transfusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Management of Mandibular Fractures via Intraoral approach.
Procedure: Open Reduction & Internal Fixation
Open Reduction & Internal Fixation of Mandibular fracture either through intraoral or extraoral approaches.
Management of Mandibular Fractures via Extraoral approach.
Procedure: Open Reduction & Internal Fixation
Open Reduction & Internal Fixation of Mandibular fracture either through intraoral or extraoral approaches.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IL-17
Time Frame: 6- weeks
Interleukin-17
6- weeks
OPG
Time Frame: 6- weeks
Osteoprotegerin
6- weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood Loss
Time Frame: in operation room
in operation room
Operative time
Time Frame: Operative time in minutes
Operative time in minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aya Ayman Ahmed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2024

Primary Completion (Estimated)

April 15, 2024

Study Completion (Estimated)

December 15, 2025

Study Registration Dates

First Submitted

March 31, 2024

First Submitted That Met QC Criteria

March 31, 2024

First Posted (Actual)

April 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

March 31, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A.Ayman OMFS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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