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Clinical Trials/CTRI/2022/04/041581
CTRI/2022/04/041581Not yet recruitingPhase 3

COMPARATIVE EVALUATION OF TREATMENT OUTCOMES AFTER FIXATION OF CONDYLAR FRACTURES WITH 3-D MINIPLATE VERSUS CONVENTIONAL MINIPLATE: A RANDOMISED CLINICAL TRIA

PRAVARA INSTITUTE OF MEDICAL SCIENCES0 sites0 target enrollmentStarted: TBDLast updated:

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Inclusion Criteria

  • 1.Patients with diagnosed Condylar neck/Subcondylar with or without other mandible fractures(according to Lindahls classification)
  • 2.Patients with dentition complete enough to apply Erichâ??s arch bars
  • 3.Patients with absent or minimal dental restorations
  • 4.Presence of Molar relation for placement of bite force measurement device.
  • 5.Patients above 18 years of age and of any gender.
  • 6.Patients willing to give written and informed consent before any study specific procedure.
  • 7.Hemodynamically stable patients

Exclusion Criteria

  • 1.Patients with edentulous ridges.
  • 2.Patients with associated other facial bone fractures.
  • 3.Patients with head injury or any neurosensory deficit
  • 4.Presence of periodontally compromised teeth.
  • 5.Active Hepatitis B virus or Hepatitis C virus, HIV/AIDS
  • 6.Known case of tuberculosis/AKT therapy, patients on long term steroid therapy, immune compromised patients, patients having chronic diseases, uncontrolled diabetes.
  • 7.Subjects having psychiatry morbidity
  • 8.Subjects who declared unfit for general anaesthesia by anaesthetics as SOP
  • 9.Subject who are planning to become pregnant within five months of surgery, lactating mother
  • 10.Subjects having any kind of disorder that compromises the ability of subject to think rationally and/or prevent from completing the study as per protocol.

Investigators

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