Aim of study:Comparison of the Effects of celecoxib, celecoxib – caffeine and Ibuprofen on pain control after crown lengthening.
Inclusion criteria:
_The patient has no history of systemic disease.
_At least 48 hours prior eaten to study drug is not received analgesic drug.
Excluded Criteria:
_Patients with any periodontal surgery within the last 6 months.
Gelatin capsules prepared by a similar and in The capsules is placed contents of celecoxib and ibuprofen and Celecoxib combined with caffeine.Capsules prepared by a third party and are coded.and placed in envelopes similar and drug-related code is written on each envelope. Do not know Treating and patients none of the types of drugs.Administration and Dosage of drugs given to patients by the person responsible for the coding(double blind).
Patients will be enrolled after completing the questionnaire.Patients are treated by periodontics residents.Unification is divided patients between students.The results are the same for all surgery is performed in an area of the mouth. 45 eligible patients were selected and randomly divided into 3 groups. The first group of ibuprofen400 mg Group II Celecoxib 150mg Group III Celecoxib 150mg + caffeine30mg.
Drug use:
Any person 0/5 hours before surgery, a dose of the drug is administered,Between 1 and 8, 16 and 24 hours after surgery, the next dose of medication is administered in each group.Changes in VAS score at 1, 2, 4, 8, 16, 24 and 48 after the operation is recorded in the relevant forms.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201305253813N2
Registration date:2013-07-24, 1392/05/02
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-07-24, 1392/05/02
Registrant information
Name
Niloofar Jenabian
Name of organization / entity
Dental Faculty of University of Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1229 1408
Email address
n.jenabian@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and technology, Babol University of Medical Sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effects of celecoxib, celecoxib – caffeine and Ibuprofen on pain control after crown lengthening.
Public title
Comparison of the Effects of celecoxib, celecoxib – caffeine and Ibuprofen on pain control after Surgery
Purpose
Supportive
Inclusion/Exclusion criteria
(Inclusion criteria:The patient has no history of systemic disease;The patient has no history of sensitivity to nonsteroidal anti-inflammatory drugs;Age of the patients ranged in age from 20 to 60 years;At least 48 hours prior eaten to study drug is not received analgesic drug;The patient was able to read, understand and complete the questionnaire;Excluded Criteria:Pregnant or lactating patients;Patients with gastrointestinal diseases such as peptic ulcer;Patients with any periodontal surgery within the last 6 months;Patients with severe anxiety and fear when visiting the dentist.)
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
Babol, St. Ganjafroz, Medical Sciences
City
Babol
Postal code
4717641367
Approval date
2013-03-09, 1391/12/19
Ethics committee reference number
302159/ژ/پ
Health conditions studied
1
Description of health condition studied
Pain after Surgery
ICD-10 code
K08.8
ICD-10 code description
Other specified disorders of teeth and supporting structures
Primary outcomes
1
Description
Pain after Surgery
Timepoint
Hour 1, 2, 4, 8, 16, 24 and 48 after surgery.
Method of measurement
VAS
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Composition celecoxib 150 mg/ caffeine 30 mg, 0.5 hours before surgery and nest doses 1 and 8, 16 and 24 hours after surgery.
Category
Treatment - Drugs
2
Description
Control group: Celecoxib 150 mg, 0.5 hours before surgery and next doses 1 and 8, 16 and 24 hours after surgery.
Category
Treatment - Drugs
3
Description
Control group: Ibuprofen 400 mg, 0.5 hours before surgery and next doses 1 and 8, 16 and 24 hours after surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol Dental School
Full name of responsible person
Dr.Niloofar Jenabian
Street address
Babol, Velayat Square, St Felestin, Babol Dental School
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research and technology, Babol University of Medical Sciences
Full name of responsible person
Dr.Amrollah Mostafazadeh
Street address
Babol, St. Ganjafroz, University of Medical Sciences
City
Babol
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 and technology, Babol 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol dental school
Full name of responsible person
Dr.Niloofar Jenabian
Position
Associate Professor, Department of Periodontology, School of Dentistry, Babol
Other areas of specialty/work
Street address
Velayat Square, St Felestin, Dental school
City
Babol
Postal code
4717641367
Phone
+98 11122914089
Fax
+98 22 91093
Email
niloofarjenabian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol dental school
Full name of responsible person
Reza Beyraghshamshir
Position
Dental Students
Other areas of specialty/work
Street address
Velayat Square, St Felestin, Dental school
City
Babol
Postal code
4717641367
Phone
+98 11122914089
Fax
+98 22 91093
Email
rbeyragh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)