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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

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

Condition or disease Intervention/treatment Phase
Trismus Edema Drug: arveles Drug: intrafen Other: placebos Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Impact of Preemptive Intravenous Ibuprofen on Postoperative Edema and Trismus in the Third Molar Teeth
Actual Study Start Date : May 15, 2017
Estimated Primary Completion Date : October 30, 2017
Estimated Study Completion Date : November 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Active Comparator: arveles
800 mg ibuprofen and 50 mg arveles in 150 cc normal saline before operation will be given in 30 minutes.
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.

Active Comparator: intrafen
intrafen 800 mg in 150 cc normal saline before operation will be given in 30 minutes.
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.

Placebo Comparator: placebos
Pre-operative 150 cc normal saline will be delivered in 30 minutes
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.




Primary Outcome Measures :
  1. Edema size measured by tape measure method [ Time Frame: 6 month ]
    the effect of preemptive intravenous ibuprofen on postoperative edema size


Secondary Outcome Measures :
  1. Maximum mouth opening measured with vernier caliper [ Time Frame: 6 month ]
    the effect of preemptive intravenous ibuprofen on postoperative trismus rate



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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03170713


Locations
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Turkey
Erzincan University
Erzincan, Turkey, 24100
Sponsors and Collaborators
Erzincan University
Investigators
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Principal Investigator: ilke kupeli Erzincan University

Publications of Results:
Other Publications:
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Responsible Party: ILKE KUPELI, assist. prof., Erzincan University
ClinicalTrials.gov Identifier: NCT03170713     History of Changes
Other Study ID Numbers: ERZINCAN UNIVERSITY 10
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ILKE KUPELI, Erzincan University:
Preemptive intravenous ibuprofen
trismus
edema
Third molar tooth extraction
Antiinflammatory effect
Additional relevant MeSH terms:
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Ibuprofen
Trismus
Edema
Signs and Symptoms
Spasm
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Dexketoprofen trometamol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action