The aim of this study was to compare the efficacy of curcumin gel 5% with triamcinolon acetonide 0/1% in treatment of recurrent aphthous stomatitis.
58 patients with minor aphthous stomatitis(less than 48 hours duration) participated in this double blind ,clinical trial study.Pateints excluded from the study if they had major aphthous stomatitis,multiple aphthous ulcers and pregnant and breast feeding women They divided in two groups. curcumin gel 5% and triamcinolon acetonide 0/1% were used 3 times a day for two weeks in group A and B respectively. Lesion’s size and pain severity( based on Visual analogue scale) were recorded before (on day 0) and during treatment (on days 1, 4, 7, 10).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201412242950N3
Registration date:2015-04-17, 1394/01/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-04-17, 1394/01/28
Registrant information
Name
Sayed Javad Kia
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1323 0775
Email address
djavadkia@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chacellorship of Research of Guilan University of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
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
Efficacy of curcumin gel 5%vs triamcinolon acetonide0/1% ointment on treatment of recurrent aphthous stomatitis.
Public title
Efficacy of curcumin gel 5%vs triamcinolon acetonide0/1% ointment on treatment of recurrent aphthous stomatitis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:patients with minor aphthous ulcer less than 48 hours
Exclusion criteria:major aphthous ulcer,multiple aphthous ulcer,pregnant and breast feeding women
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
58
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
Ethics Committee Research Vice Chacellorship of Guilan University of Medical Sciences
Street address
Research Vice Chacellorship of Guilan University of Medical Sciences building,Opposite sepah bank, Shahid beheshti Blv
City
Rasht
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
12414
Health conditions studied
1
Description of health condition studied
Reccurent aphthous stomatitis
ICD-10 code
k00-k14
ICD-10 code description
Recurrent oral aphthae
Primary outcomes
1
Description
pain sensation
Timepoint
before starting study,days 1,4 ,7 ,10
Method of measurement
Use of visual analoge scale (VAS) from 0- 10, 0: no pain
Secondary outcomes
1
Description
Healing recurrent aphthous ulcers
Timepoint
days 1,4,7,10
Method of measurement
Measuring of ulcers by ruler
Intervention groups
1
Description
Control: Triamcinolone in oral base Ointment (Triadent), topical use in oral mucosa ulcer, 3 time/day, after meal, for 10 days
Category
Treatment - Drugs
2
Description
Intervention: Curcumin Gel-topical use in oral mucosa ulcer, 3 time/day, after meal for 10 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental school of Guilan University of Medical Siences
Full name of responsible person
Dr Seyed Javad Kia
Street address
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice Chacellorship of Guilan University of Medical Sciences
Full name of responsible person
Dr Abtin Heydarzadeh
Street address
Research Vice Chacellorship of Guilan University of Medical Sciences Building, Opposite Sepah Bank, shahid beheshti Blv
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice Chacellorship of Guilan 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
Dental School
Full name of responsible person
Dr Seyed Javad Kia
Position
Assistant proffesor
Other areas of specialty/work
Street address
Foman Saravan Road
City
Rasht
Postal code
Phone
+98 13 3348 6411
Fax
Email
djavadkia@yahoo.com; djavadkia@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental School
Full name of responsible person
Dr Seyed Javad Kia
Position
Assistant Proffesor
Other areas of specialty/work
Street address
Foma Saravan Road
City
Rasht
Postal code
Phone
+98 13 3348 6411
Fax
Email
djavadkia@yahoo.com; djavadkia@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental School
Full name of responsible person
Dr Seyed Javad Kia
Position
Professor Assistant
Other areas of specialty/work
Street address
Saravan Foman Road
City
Rasht
Postal code
Phone
+1 333446811
Fax
Email
djavadkia@yahoo.com; djavadkia@gums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)