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

NCT ID: NCT03170713

Last Updated: 2017-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-15

Study Completion Date

2017-11-15

Brief Summary

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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

Detailed Description

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Conditions

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Trismus Edema

Keywords

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Preemptive intravenous ibuprofen trismus edema Third molar tooth extraction Antiinflammatory effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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arveles

800 mg ibuprofen and 50 mg arveles in 150 cc normal saline before operation will be given in 30 minutes.

Group Type ACTIVE_COMPARATOR

arveles

Intervention Type DRUG

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

Intervention Type DRUG

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.

placebos

Intervention Type OTHER

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

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

Group Type ACTIVE_COMPARATOR

arveles

Intervention Type DRUG

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

Intervention Type DRUG

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.

placebos

Intervention Type OTHER

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.

placebos

Pre-operative 150 cc normal saline will be delivered in 30 minutes

Group Type PLACEBO_COMPARATOR

arveles

Intervention Type DRUG

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

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

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.

Intervention Type OTHER

Other Intervention Names

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dexketoprofen ibuprofen i.v.

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erzincan University

OTHER

Sponsor Role lead

Responsible Party

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ILKE KUPELI

assist. prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ilke kupeli

Role: PRINCIPAL_INVESTIGATOR

Erzincan University

Locations

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Erzincan University

Erzincan, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 16725024 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18088870 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17694761 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16280233 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18296027 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18272338 (View on PubMed)

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.

Reference Type RESULT
PMID: 19375022 (View on PubMed)

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.

Reference Type RESULT
PMID: 17157479 (View on PubMed)

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.

Reference Type RESULT
PMID: 22654361 (View on PubMed)

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

Reference Type RESULT

Other Identifiers

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ERZINCAN UNIVERSITY 10

Identifier Type: -

Identifier Source: org_study_id