The purpose of this study is to evaluate the effect of saffron on pain control after root canal therapy in vital teeth. This is a randomized triple blind placebo control clinical trial.
Among patients refer to endodontics department of Tehran Faculty of Dentistry whom with moderate to severe pain in a single canal tooth will be selected and randomly divided in 2 groups of saffron and placebo. 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, 36 patients (18 in each group) will be entered in study.
After treatment each patient in each group will receive a box of 8 similar capsules. They will use 1 capsule exactly after treatment completion and then each 6 hours up to 48 hours.
Patients will record their pain intensity in each time period and finally mean pain intensity will be compared between 2 groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204039367N1
Registration date:2012-04-16, 1391/01/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-04-16, 1391/01/28
Registrant information
Name
Kaveh Oloumi
Name of organization / entity
Department of Endodontics, Faculty of Dentistry, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 42794445
Email address
bolhari@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan university of medical sciences, Vice-chancellor for research
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2012-06-21, 1391/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of saffron (Crocus sativus) on pain control after root canal therapy in teeth with vital pulps
Public title
Effect of saffron on dental pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: vital teeth with one root canal and moderate to severe pain and patients over 18 years old with at least high school education
Exclusion criteria: teeth with periapical lesions; patients with history of allergy to saffron; diabetes mellitus, cardiovascular disorders, kidney and liver diseases, blood and hormonal disorders and electrolyte imbalance; women in pregnancy or breast feeding period and use of analgesics or opioids during 4 hours before treatment.
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:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zahedan University of Medical Sciences Ethics Committe
Street address
Pardis of Zahedan Univsity of Medical Sciences - Khalij-e-Fars Blv.- Dr. Hesabi Sq.- Zahedan
City
Zahedan
Postal code
98167-43463
Approval date
2011-12-03, 1390/09/12
Ethics committee reference number
90-1774
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
Every 6 hours after treatment completion up to 48 hours
Method of measurement
Visual Analog Scale(VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention:
saffron with dose of 100 mg in each capsule every 6 hours up to 48 hours (400 mg/day)
Category
Treatment - Drugs
2
Description
Control:starch with dose of 100 mg in each capsule every 6 hours up to 48 hours (400 mg/day)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of endodontics, Faculty of Dentistry, Tehran University of Medical Sciences
Full name of responsible person
Dr. Kaveh Oloomi
Street address
Department of Endodontics, Tehran Faculty of Dentistry, North Karegar St., Tehran.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Scienves, Vice-chencellor 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
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 Scienves, Vice-chencellor 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
Endodontics Department- Faculty of Dentistry- Tehran University of Medical Sciences
Full name of responsible person
Dr. Kaveh Oloomi
Position
Assistant Professor/Endodontist
Other areas of specialty/work
Street address
Endodontics Department-Tehran Faculty of Dentistry-North Karegar St.-Tehran
City
Tehran
Postal code
1439955991
Phone
+98 21 8835 1173
Fax
Email
koloomi@yahoo.com
Web page address
http://dentistry.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Endodontics Department- Faculty of Dentistry- Tehran University of Medical Sciences
Full name of responsible person
Dr. Kaveh Oloomi
Position
Assistant Professor/Endodontist
Other areas of specialty/work
Street address
Endodontics Department-Tehran Faculty of Dentistry-North Karegar St.-Tehran
City
Tehran
Postal code
1439955991
Phone
+98 21 8835 1173
Fax
+98 88497400
Email
koloomi@yahoo.com
Web page address
http://dentistry.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Endodontics Department- Faculty of Dentistry- Tehran University of Medical Sciences
Full name of responsible person
Dr. Kaveh Oloomi
Position
Assistant Professor/Endodontist
Other areas of specialty/work
Street address
Endodontics Department-Tehran Faculty of Dentistry-North Karegar St.-Tehran
City
Tehran
Postal code
1439955991
Phone
+98 21 8835 1173
Fax
+98 88497400
Email
koloomi@yahoo.com
Web page address
http://dentistry.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)