NCT06349135

Brief 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 5, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

April 15, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

April 5, 2024

Status Verified

March 1, 2024

Enrollment Period

Same day

First QC Date

March 31, 2024

Last Update Submit

March 31, 2024

Conditions

Mandibular Fractures

Outcome Measures

Primary Outcomes (2)

  • IL-17

    Interleukin-17

    6- weeks

  • OPG

    Osteoprotegerin

    6- weeks

Secondary Outcomes (2)

  • Blood Loss

    in operation room

  • Operative time

    Operative time in minutes

Study Arms (2)

Management of Mandibular Fractures via Intraoral approach.

Management of Mandibular Fractures via Intraoral approach.

Procedure: Open Reduction & Internal Fixation

Management of Mandibular Fractures via Extraoral approach.

Management of Mandibular Fractures via Extraoral approach.

Procedure: Open Reduction & Internal Fixation

Interventions

Open Reduction & Internal FixationPROCEDURE

Open Reduction \& Internal Fixation of Mandibular fracture either through intraoral or extraoral approaches.

Management of Mandibular Fractures via Extraoral approach.Management of Mandibular Fractures via Intraoral approach.

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with single mandibular fracture.

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mandibular Fractures

Interventions

Open Fracture ReductionFracture Fixation, Internal

Condition Hierarchy (Ancestors)

Jaw FracturesMaxillofacial InjuriesFacial InjuriesCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesSkull FracturesFractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
lecturer assistant

Study Record Dates

First Submitted

March 31, 2024

First Posted

April 5, 2024

Study Start

April 15, 2024

Primary Completion

April 15, 2024

Study Completion

December 15, 2025

Last Updated

April 5, 2024

Record last verified: 2024-03