(1) Objective: The purpose of this study is to Comparative effect of saffron petal and stigma extract with Ibuprofen on pain control after root canal therapy in vital teeth. (2) Design: This is a randomized triple blind clinical trial. (3)Setting and conduct: Among patients refer to endodontics department of zahedan Faculty of Dentistry whom with moderate to severe pain in a single canal tooth will be selected and randomly divided in 3 groups of petal, stigma extract and Ibuprofen. (4) Participants including major eligibility criteria: Patients should not have any history of allergy to saffron, diabetes, cardiovascular disorders, kidney and liver diseases, blood and hormonal disorders and electrolyte imbalance. According to previous studies and based on sample size formula and possibility of drop out during the study, 60 patients (20 in each group) will be entered in study. (5) Intervention: After treatment each patient in each group will receive a box of 5 similar capsules. They will use 1 capsule exactly after treatment completion and then 6, 12, 24 and 48 hours after treatment. (6) main outcome measures: Patients will record their pain intensity in each time period and finally mean pain intensity will be compared between 3 groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013051713354N1
Registration date:2013-10-29, 1392/08/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-10-29, 1392/08/07
Registrant information
Name
Mojtaba Bazrafshan
Name of organization / entity
Zahedan Univsity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 1342 5789
Email address
mojtaba_bazrafshan@yahoo.com
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences, Vice-chancellor for research
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2014-05-22, 1393/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effect of saffron petal and stigma extract with Ibuprofen in post endodontic pain management
Public title
Comparative effect of saffron extract with Ibuprofen in dental pain management
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1-vital teeth with one root canal; 2- moderate to severe pain; 3-patients over 18 years old; 4- patients with at least high school education.
Exclusion criteria: 1- teeth with periapical lesions based on radiographic; 2- patients with history of allergy to saffron; 3- patients with history of allergy to NSAID; 4- diabetes mellitus, cardiovascular disorders, kidney and liver diseases, blood and hormonal disorders and electrolyte imbalance; 5- use of analgesics or opioids during 4 hours before treatment; 6- women in pregnancy or breast feeding period.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zahedan University of Medical Sciences Ethics Committee
Street address
Pardis of Zahedan University of Medical Sciences, Khalij-e-Fars Blv, Dr. Hesabi Sq, Zahedan, Iran
City
Zahedan
Postal code
Approval date
2013-05-12, 1392/02/22
Ethics committee reference number
92-184
Health conditions studied
1
Description of health condition studied
Post-treatment pain after root canal therapy
ICD-10 code
k04
ICD-10 code description
Diseases of pulp and periapical tissues
Primary outcomes
1
Description
Pain intensity
Timepoint
0 - 6 - 12 - 24 and 48 hours after root canal treatment
Method of measurement
Visual Analog Scale (VAS)
Secondary outcomes
1
Description
Lack of pain intensity
Timepoint
0-6-12-24-48
Method of measurement
Visual Analog Scale(VAS)
Intervention groups
1
Description
saffron stigma extract with dose of 10 mg in each pink opaque capsule in 0, 6, 12, 24, 48 h after treatment
Category
Treatment - Drugs
2
Description
400 mg ibuprofen in each pink opaque
capsule in 0, 6, 12, 24, 48 h after treatment
Category
Treatment - Drugs
3
Description
saffron petal extract with dose of 10 mg in each pink opaque capsule in 0, 6, 12, 24, 48 h after treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan Faculty of Dentistry
Full name of responsible person
Mojtaba Bazrafshan
Street address
Eastern Azadegan St, Zahedan Faculty of Dentistry, Zahedan, Iran
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences, Vice-chancellor for research
Full name of responsible person
Dr. Mohsen Taheri
Street address
Pardis of Zahedan Univsity of Medical Sciences, Khalij-e-Fars Blv, Dr. Hesabi Sq, Zahedan, Iran
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences, Vice-chancellor for research
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
Zahedan University of Medical Sciences
Full name of responsible person
Mojtaba Bazrafshan
Position
Dentistry Student
Other areas of specialty/work
Street address
Zahedan faculty of dentistry, Eastern Azadegan St, Zahedan, Iran
City
Zahedan
Postal code
Phone
+98 54 1341 6708
Fax
Email
mojtaba_bazrafshan@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Endodontics, Zahedan Faculty of Dentistry
Full name of responsible person
Dr Narges Farhadmollashahi
Position
Assistant Professor
Other areas of specialty/work
Street address
Endodontics Department, Faculty of Dentistry, Eastern Azadegan St, Zahedan, Iran
City
Zahedan
Postal code
Phone
+98 54 1241 4004
Fax
Email
nargesfarhadm@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mojtaba Bazrafshan
Position
Dentistry Student
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
mojtaba_bazrafshan@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)