The aim of study is to compare the effect of preemptive analgesic use for reduction of pain after third molar emoval between men and women
Healthy patients having impacted thir molar that need partial removal of bone for extraction with ages of 18 t0 40 yrs old ( 30 men and 30 women) will be included in the study after signing the consent form. Patients with a history of peptic ulcer or systemic disease, hpersensitivity to NSAIDs or used pain medication within 8 hrs of surgery and pergnant women will be excluded from the study. Ibuprofen 400mg will be given to each participant, one hour before surgery. Patients are asked to record their pain intensity on a visual analogue scale (VAS) during 24 hrs after surgery. 20 tablets of ibuprofen 400 mg will be given to each patient to consume as needed for pain relief. Patients are asked to report total number of tablets consumed within 24 hra after the surgery and also to report the time of first tablet taken after surgery. Dental anxiety of patients will be assessed by Corah’s anxiety scale before surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204279566N1
Registration date:2014-04-17, 1393/01/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-04-17, 1393/01/28
Registrant information
Name
Masoumeh Emamghoreishi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 7591
Email address
emamm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2013-08-01, 1392/05/10
Expected recruitment end date
2014-07-29, 1393/05/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effects of ibuprofen administration before surgery on reduction of pain after removal of impacted third molar between women and men
Public title
Evaluating the effects of ibuprofen administration before surgery on reduction of pain after removal of wisdom teeth in women and men
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria
1. have impacted third molar in lower jaw (one or two side)
2. Having teeth needed partial removal of bone for extraction
3. Lack of history of GI disease and peptic ulcer
4. Lack of systemic diseases such as diabetes, chronic renal failure, chronic hepatic impairment, ...
5. Lack of hypersensitivity to aspirin or related compounds
6. Lack of use of drugs that interfere with analgesic effects of NSAIDs. Exclusion criteria: 1- Active infection immediately before or after surgery.
2- Use of other analgesics within 8 hours of surgery.
3- History of gastric ulcers or erosion.
4-history of anti coagulation therapy
5- History of asthma, nasal polyps, and allergic disorders associated with aspirin and other NSAID.
6- Uncontrolled systemic diseases
7- Female patients who were pregnant or who were not using an accepted from of birth control.
Age
From 18 years old to 40 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic comittee of Shiraz University of Medical Sciences
Street address
Zand Street, Shiraz university of medical sciences
City
Shiraz
Postal code
Approval date
2011-08-01, 1390/05/10
Ethics committee reference number
CT-90-3249
Health conditions studied
1
Description of health condition studied
Third molar extraction
ICD-10 code
k01.1
ICD-10 code description
An impacted tooth is a tooth that has failed to erupt because of obstruction by another tooth
Primary outcomes
1
Description
Pain intensity
Timepoint
Within 24 hrs of surgery with 2 hrs time intervals
Method of measurement
VAS
Secondary outcomes
1
Description
Total analgesic consumption and time to first analgesic use
Timepoint
Within 24 hrs after the surgery
Method of measurement
Self report
Intervention groups
1
Description
Administration of 400 mg ibuprofen tablet before usual third molar extraction by a surgeon
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
School of dentistry, department of orofacial surgery
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Vice Chancellor of Research- Dr. Syed Basir Hashemi
Street address
#7 floor, Central building, Shiraz university of Medical Sciences, Zand street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences- Medical School
Full name of responsible person
Dr. Masoumeh Emamghoreishi
Position
Associate professor/PhD
Other areas of specialty/work
Street address
Department of pharmacology- School of Medicine-Zand Street-
City
Shiraz
Postal code
7134853185
Phone
+98 71 1230 7591
Fax
Email
emamm@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Masoumeh Emamghoreishi
Position
Associate professor/PhD
Other areas of specialty/work
Street address
Department of pharmacology- School of Medicine-Zand street-
City
shiraz
Postal code
7134853185
Phone
+98 71 1230 7591
Fax
Email
emamm@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Masoumeh Emamghoreishi
Position
PhD in Pharmacology
Other areas of specialty/work
Street address
Department of Pharmacology, School of Medicine, Zand Street
City
Shiraz
Postal code
7134853185
Phone
+98 71 1230 7591
Fax
emamm@sums.ac.ir
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)