- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03170713
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
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
-
-
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Erzincan, Turkey, 24100
- Erzincan University
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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
18 years to 33 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.
|
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:
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:
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.
|
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:
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:
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
|
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:
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:
|
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
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
- Colorado-Bonnin M, Valmaseda-Castellon E, Berini-Aytes L, Gay-Escoda C. Quality of life following lower third molar removal. Int J Oral Maxillofac Surg. 2006 Apr;35(4):343-7. doi: 10.1016/j.ijom.2005.08.008. Epub 2005 Nov 8.
- Jerjes W, El-Maaytah M, Swinson B, Banu B, Upile T, D'Sa S, Al-Khawalde M, Chaib B, Hopper C. Experience versus complication rate in third molar surgery. Head Face Med. 2006 May 25;2:14. doi: 10.1186/1746-160X-2-14.
- Vegas-Bustamante E, Mico-Llorens J, Gargallo-Albiol J, Satorres-Nieto M, Berini-Aytes L, Gay-Escoda C. Efficacy of methylprednisolone injected into the masseter muscle following the surgical extraction of impacted lower third molars. Int J Oral Maxillofac Surg. 2008 Mar;37(3):260-3. doi: 10.1016/j.ijom.2007.07.018. Epub 2008 Mar 4.
- Bouloux GF, Steed MB, Perciaccante VJ. Complications of third molar surgery. Oral Maxillofac Surg Clin North Am. 2007 Feb;19(1):117-28, vii. doi: 10.1016/j.coms.2006.11.013.
- Chukwuneke F, Onyejiaka N. Management of postoperative morbidity after third molar surgery: a review of the literature. Niger J Med. 2007 Apr-Jun;16(2):107-12. doi: 10.4314/njm.v16i2.37291.
- Chukwuneke FN, Oji C, Saheeb DB. A comparative study of the effect of using a rubber drain on postoperative discomfort following lower third molar surgery. Int J Oral Maxillofac Surg. 2008 Apr;37(4):341-4. doi: 10.1016/j.ijom.2007.11.016. Epub 2008 Feb 12.
- Sato FR, Asprino L, de Araujo DE, de Moraes M. Short-term outcome of postoperative patient recovery perception after surgical removal of third molars. J Oral Maxillofac Surg. 2009 May;67(5):1083-91. doi: 10.1016/j.joms.2008.09.032.
- Markovic A, Todorovic Lj. Effectiveness of dexamethasone and low-power laser in minimizing oedema after third molar surgery: a clinical trial. Int J Oral Maxillofac Surg. 2007 Mar;36(3):226-9. doi: 10.1016/j.ijom.2006.10.006. Epub 2006 Dec 8.
- Jain N, Maria A. Randomized double blind comparative study on the efficacy of Ibuprofen and aceclofenac in controlling post-operative sequelae after third molar surgery. J Maxillofac Oral Surg. 2011 Jun;10(2):118-22. doi: 10.1007/s12663-011-0198-9. Epub 2011 Apr 22.
- Agarwal S, Chattopadhyay S, Mandal M. Comparison of efficacy of aceclofenac and ibuprofen after surgical removal of impacted third molar. J. Evolution Med. Dent. Sci. 2017;6(21):1670-1677, DOI: 10.14260/Jemds/2017/368
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
- Nervous System Diseases
- Neurologic Manifestations
- Neuromuscular Manifestations
- Spasm
- Edema
- Trismus
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Ibuprofen
- Dexketoprofen trometamol
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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