NCT03170713

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2017

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2017

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

6 months

First QC Date

May 20, 2017

Last Update Submit

May 26, 2017

Conditions

TrismusEdema

Keywords

Preemptive intravenous ibuprofentrismusedemaThird molar tooth extractionAntiinflammatory effect

Outcome Measures

Primary Outcomes (1)

  • Edema size measured by tape measure method

    the effect of preemptive intravenous ibuprofen on postoperative edema size

    6 month

Secondary Outcomes (1)

  • Maximum mouth opening measured with vernier caliper

    6 month

Study Arms (3)

arveles

ACTIVE COMPARATOR

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

Drug: arvelesDrug: intrafenOther: placebos

intrafen

ACTIVE COMPARATOR

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

Drug: arvelesDrug: intrafenOther: placebos

placebos

PLACEBO COMPARATOR

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

Drug: arvelesDrug: intrafen

Interventions

arvelesDRUG

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.

Also known as: dexketoprofen
arvelesintrafenplacebos
intrafenDRUG

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.

Also known as: ibuprofen i.v.
arvelesintrafenplacebos
placebosOTHER

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.

arvelesintrafen

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Elective 3. Molar tooth extraction
  • Patients between the ages of 20-35
  • Patients who are symptomatic
  • \. Molar tooth angular or horizontal settled patients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzincan University

Erzincan, 24100, Turkey (Türkiye)

Location

Related Publications (10)

  • 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.

    PMID: 16725024BACKGROUND

  • 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.

    PMID: 18088870BACKGROUND

  • 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.

    PMID: 17694761BACKGROUND

  • 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.

    PMID: 16280233BACKGROUND

  • 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.

    PMID: 18296027BACKGROUND

  • 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.

    PMID: 18272338BACKGROUND

  • 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.

    PMID: 19375022RESULT

  • 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.

    PMID: 17157479RESULT

  • 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.

    PMID: 22654361RESULT

  • 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

    RESULT

MeSH Terms

Conditions

TrismusEdema

Interventions

dexketoprofen trometamol

Condition Hierarchy (Ancestors)

SpasmNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • ilke kupeli

    Erzincan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assist. prof.

Study Record Dates

First Submitted

May 20, 2017

First Posted

May 31, 2017

Study Start

May 15, 2017

Primary Completion

October 30, 2017

Study Completion

November 15, 2017

Last Updated

May 31, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)