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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: October 30, 2017

Interventions

  • 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.
  • 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: 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.

Arms, Groups and Cohorts

  • Active Comparator: arveles
    • 800 mg ibuprofen and 50 mg arveles in 150 cc normal saline before operation will be given in 30 minutes.
  • Active Comparator: intrafen
    • intrafen 800 mg in 150 cc normal saline before operation will be given in 30 minutes.
  • Placebo Comparator: placebos
    • Pre-operative 150 cc normal saline will be delivered in 30 minutes

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Erzincan University
  • Provider of Information About this Clinical Study
    • Principal Investigator: ILKE KUPELI, assist. prof. – Erzincan University
  • Overall Official(s)
    • ilke kupeli, Principal Investigator, Erzincan University

References

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.

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.

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.

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.

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.

Citations Reporting on Results

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

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