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Impact of Preemptive Intravenous Ibuprofen on Postoperative Edema and Trismus in the Third Molar Teeth

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ClinicalTrials.gov Identifier: NCT03170713
Recruitment Status : Unknown
Verified May 2017 by ILKE KUPELI, Erzincan University.
Recruitment status was:  Active, not recruiting
First Posted : May 31, 2017
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
ILKE KUPELI, Erzincan University

Tracking Information
First Submitted Date  ICMJE May 20, 2017
First Posted Date  ICMJE May 31, 2017
Last Update Posted Date May 31, 2017
Actual Study Start Date  ICMJE May 15, 2017
Estimated Primary Completion Date October 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2017)
Edema size measured by tape measure method [ Time Frame: 6 month ]
the effect of preemptive intravenous ibuprofen on postoperative edema size
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2017)
Maximum mouth opening measured with vernier caliper [ Time Frame: 6 month ]
the effect of preemptive intravenous ibuprofen on postoperative trismus rate
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Preemptive Intravenous Ibuprofen on Postoperative Edema and Trismus in the Third Molar Teeth
Official Title  ICMJE Impact of Preemptive Intravenous Ibuprofen on Postoperative Edema and Trismus in the Third Molar Teeth
Brief Summary this study was planned to investigate the antiinflammatory activity of preemptive intravenous ibuprofen on inflammatory complications such as edema and trismus after third molar tooth surgery
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Trismus
  • Edema
Intervention  ICMJE
  • Drug: arveles
    800 mg ibuprofen and 50 mg dexketoprofen in 150 cc normal saline before operation will be given in 30 minutes. The edema size, mouth opening (trismus) will be recorded in all patients in the preoperative period, postoperative period, postoperative 48th hour and 1 st week.
    Other Name: dexketoprofen
  • Drug: intrafen
    800 mg ibuprofen in 150 cc normal saline before operation will be given in 30 minutes.The edema size, mouth opening (trismus) will be recorded in all patients in the preoperative period, postoperative period, postoperative 48th hour and 1 st week.
    Other Name: ibuprofen i.v.
  • Other: placebos
    150 cc normal saline before operation will be given in 30 minutes.The edema size, mouth opening (trismus) will be recorded in all patients in the preoperative period, postoperative period, postoperative 48th hour and 1 st week.
Study Arms  ICMJE
  • Active Comparator: arveles
    800 mg ibuprofen and 50 mg arveles in 150 cc normal saline before operation will be given in 30 minutes.
    Interventions:
    • Drug: arveles
    • Drug: intrafen
    • Other: placebos
  • Active Comparator: intrafen
    intrafen 800 mg in 150 cc normal saline before operation will be given in 30 minutes.
    Interventions:
    • Drug: arveles
    • Drug: intrafen
    • Other: placebos
  • Placebo Comparator: placebos
    Pre-operative 150 cc normal saline will be delivered in 30 minutes
    Interventions:
    • Drug: arveles
    • Drug: intrafen
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 26, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 15, 2017
Estimated Primary Completion Date October 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Elective 3. Molar tooth extraction
  • Patients between the ages of 20-35
  • Patients who are symptomatic
  • 3. Molar tooth angular or horizontal settled patients

Exclusion Criteria:

  • Patients who refuse to participate in the study
  • Patients under 20 years old, over 35 years old
  • Patients who are allergic to known non-steroidal anti-inflammatory drugs
  • Pregnant patients
  • Patients with severe hepatic insufficiency
  • Patients with severe renal insufficiency
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03170713
Other Study ID Numbers  ICMJE ERZINCAN UNIVERSITY 10
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ILKE KUPELI, Erzincan University
Study Sponsor  ICMJE Erzincan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: ilke kupeli Erzincan University
PRS Account Erzincan University
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP