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

Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03170713
• Other study ID #: ERZINCAN UNIVERSITY 10
• Status: Active, not recruiting
• Phase: N/A
• First received: May 20, 2017
• Last updated: May 26, 2017
• Start date: May 15, 2017
• Est. completion date: November 15, 2017

Study information

• Verified date: May 2017
• Source: Erzincan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: November 15, 2017
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Trismus

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Erzincan University	Erzincan

Sponsors (1)

Lead Sponsor	Collaborator
Erzincan University

Country where clinical trial is conducted

Turkey, 

References & Publications (10)

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

Bouloux GF, Steed MB, Perciaccante VJ. Complications of third molar surgery. Oral Maxillofac Surg Clin North Am. 2007 Feb;19(1):117-28, vii. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Colorado-Bonnin M, Valmaseda-Castellón E, Berini-Aytés L, Gay-Escoda C. Quality of life following lower third molar removal. Int J Oral Maxillofac Surg. 2006 Apr;35(4):343-7. Epub 2005 Nov 8. — View Citation

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 2 — View Citation

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. — View Citation

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. Epub 2006 Dec 8. — View Citation

Sato FR, Asprino L, de Araújo 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. — View Citation

Vegas-Bustamante E, Micó-Llorens J, Gargallo-Albiol J, Satorres-Nieto M, Berini-Aytés 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Edema size measured by tape measure method	the effect of preemptive intravenous ibuprofen on postoperative edema size	6 month
Secondary	Maximum mouth opening measured with vernier caliper	the effect of preemptive intravenous ibuprofen on postoperative trismus rate	6 month