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

May 26, 2017 updated by: ILKE KUPELI, Erzincan University
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Erzincan, Turkey, 24100
        • Erzincan University

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

16 years to 31 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • ibuprofen i.v.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Edema size measured by tape measure method
Time Frame: 6 month
the effect of preemptive intravenous ibuprofen on postoperative edema size
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum mouth opening measured with vernier caliper
Time Frame: 6 month
the effect of preemptive intravenous ibuprofen on postoperative trismus rate
6 month

Collaborators and Investigators

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

Sponsor

Erzincan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

May 15, 2017

Primary Completion (Anticipated)

October 30, 2017

Study Completion (Anticipated)

November 15, 2017

Study Registration Dates

First Submitted

May 20, 2017

First Submitted That Met QC Criteria

May 26, 2017

First Posted (Actual)

May 31, 2017

Study Record Updates

Last Update Posted (Actual)

May 31, 2017

Last Update Submitted That Met QC Criteria

May 26, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERZINCAN UNIVERSITY 10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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