The aim of this study is comparison of the effects of oral administration of Dexamethasone and Ibuprofen following periodontal surgery for reducing patient’s pain and discomfort. 40 patients, with moderate to severe chronic periodontitis which require flap surgery in four quadrants of jaws for debridement are selected. The patients are divided into two equal groups with simple random sampling; group 1, patients who receive routine prescription 1 h before and after surgery (Ibuprofen 400 mg) and group 2, patients who receive 8 mg Dexamethasone tablets 1 h before surgery. This study is a single blind study in which just the practitioner and the data analyzer are aware of the used drug and patients do not know about it. Based on the amount of pain, the patients fill the questionnaire for eight hours on the first day (at intervals of one hour) and three times per day (morning, afternoon, evening) for 3 days after the surgery.
General information
Acronym
Periodontal surgery, Dexamethasone, Ibuprofen
IRCT registration information
IRCT registration number:IRCT201411025029N3
Registration date:2015-05-30, 1394/03/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-30, 1394/03/09
Registrant information
Name
Fariborz Vafaee
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1824 1961
Email address
fvafaee@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Dental school, Hamadan University of Medical Science
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-03-11, 1393/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of oral administration of dexamethasone and Ibuprofen to reduce pain in patients after periodontal surgery
Public title
Comparison of Dexamethasone and Ibuprofen following oral surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients with moderate to severe chronic periodontitis and requires surgical debridement flap in 4 quadrants
Exclusion Criteria: Patients with systemic disease, pregnant and breast feeding patients, patients with allergy to drugs, patients using antibiotic or pain relief drugs, patients with risk of infective endocarditis.
Age
From 30 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study is a single blind study in which just the practitioner and the data analyzer are aware of the used drug and patients do not know about it.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamadan University of Medical science
Street address
Ethics committee, School of dentistry, Hamedan University of Medical Sciences, Shahid fahmideh street
City
Hamedan
Postal code
Approval date
2011-12-17, 1390/09/26
Ethics committee reference number
3217/9/35/16/P/D
Health conditions studied
1
Description of health condition studied
chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis : simplex periodontitis
Primary outcomes
1
Description
Pain of patients after periodontal surgery
Timepoint
Completed questionnaires every hour for 8 hours the first day and 3 times a day (morning, afternoon, evening) at 3 days after surgery.
Method of measurement
NRS-101, VRS-4 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Ibuprofen(Daana pharma Co production) 400 mg oral, 1 hour before surgery and 400 mg every 8 hours after surgery
Category
Treatment - Drugs
2
Description
Dexamethasone(Iran hormone) tablets 8 mg oral, 1 hour before surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry Hamadan university of Medical science
Full name of responsible person
Dr Shahram Sharifi
Street address
Periodontics department, Dental school, Hamedan University of Medical Sciences, Shahid fahmideh street
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Dental school of Hamadan University of Medical Sciences
Full name of responsible person
Dr Shahin Kasraee
Street address
Vice chancellor for research, Dental school, Hamedan University of Medical Sciences, Shahid fahmideh street
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Dental school of Hamadan 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
School of Dentistry Hamadan University of Medical science
Full name of responsible person
DR Shahram Sharifi
Position
resident
Other areas of specialty/work
Street address
Periodontal department, School of dentistry, Hamedan University of Medical Sciences, Shahid fahmideh street
City
Hamedan
Postal code
Phone
+98 81 3838 0262
Fax
Email
shahramsharifi60@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Dentistry Hamadan University of Medical science
Full name of responsible person
DR Masoomeh Khoshhal
Position
assistant professor
Other areas of specialty/work
Street address
Periodontal department, School of dentistry, Hamedan University of Medical Sciences, Shahid fahmideh street
City
Hamedan
Postal code
Phone
+98 81 3838 0262
Fax
Email
khoshhalsepideh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Dentistry of Hamadan University of Medical science
Full name of responsible person
DR Shahram Sharifi
Position
Resident
Other areas of specialty/work
Street address
Periodontal department, School of dentistry, Hamedan University of Medical Sciences, Shahid fahmideh street
City
Hamedan
Postal code
Phone
+98 81 3838 0262
Fax
Email
shahramsharifi60@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)