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

Primary Purpose

Trismus, Edema

Status

Unknown status

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

arveles

intrafen

placebos

About this trial

This is an interventional prevention trial for Trismus focused on measuring Preemptive intravenous ibuprofen, trismus, edema, Third molar tooth extraction, Antiinflammatory effect

Eligibility Criteria

20 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Erzincan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

arveles

intrafen

placebos

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Edema size measured by tape measure method

the effect of preemptive intravenous ibuprofen on postoperative edema size

Secondary Outcome Measures

Maximum mouth opening measured with vernier caliper

the effect of preemptive intravenous ibuprofen on postoperative trismus rate

Full Information

NCT ID

NCT03170713

First Posted

May 20, 2017

Last Updated

May 26, 2017

Sponsor

Erzincan University

1. Study Identification

Unique Protocol Identification Number

NCT03170713

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Unknown status

Study Start Date

May 15, 2017 (Actual)

Primary Completion Date

October 30, 2017 (Anticipated)

Study Completion Date

November 15, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Erzincan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Trismus, Edema

Keywords

Preemptive intravenous ibuprofen, trismus, edema, Third molar tooth extraction, Antiinflammatory effect

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

arveles

Arm Type

Active Comparator

Arm Description

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

Arm Title

intrafen

Arm Type

Active Comparator

Arm Description

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

Arm Title

placebos

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

arveles

Other Intervention Name(s)

dexketoprofen

Intervention Description

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

Intervention Name(s)

intrafen

Other Intervention Name(s)

ibuprofen i.v.

Intervention Description

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

Other

Intervention Name(s)

placebos

Intervention Description

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.

Primary Outcome Measure Information:

Title

Edema size measured by tape measure method

Description

the effect of preemptive intravenous ibuprofen on postoperative edema size

Time Frame

6 month

Secondary Outcome Measure Information:

Title

Maximum mouth opening measured with vernier caliper

Description

the effect of preemptive intravenous ibuprofen on postoperative trismus rate

Time Frame

6 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ilke kupeli

Organizational Affiliation

Erzincan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Erzincan University

City

Erzincan

ZIP/Postal Code

24100

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

16725024

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. doi: 10.1186/1746-160X-2-14.

Results Reference

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PubMed Identifier

18088870

Citation

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.

Results Reference

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PubMed Identifier

17694761

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. doi: 10.4314/njm.v16i2.37291.

Results Reference

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PubMed Identifier

16280233

Citation

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.

Results Reference

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PubMed Identifier

18296027

Citation

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.

Results Reference

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PubMed Identifier

18272338

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.

Results Reference

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PubMed Identifier

19375022

Citation

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.

Results Reference

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PubMed Identifier

17157479

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. doi: 10.1016/j.ijom.2006.10.006. Epub 2006 Dec 8.

Results Reference

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PubMed Identifier

22654361

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 2011 Apr 22.

Results Reference

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Citation

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

Results Reference

result

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

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