Recurrent aphthous stomatitis (RAS) is a condition which is marked by painful ulcers that develop on non-keratinized oral mucosa. This condition can cause problems with swallowing, eating and speaking. Extract of rosa damascena has reportedly anti-inflammatory effects and has been traditionally used by some cultures for the treatment of oral ulcers. The aim of the present randomized, double-blind, placebo controlled investigation is to assess the clinical efficacy of a mouthwash containing aqueous extract of rosa damascena in the treatment of RAS. Patients with at least one aphthous ulcer measuring no more than 10 mm in diameter with no underlying systemic or immunologic disease will be included. Patients will randomly enter this 2 week study and the clinical efficacy of the mouthwash on size, pain and number of ulcers will be compared with that of the placebo on days 4,7,11 and 14. Both groups (experimental and placebo) will be instructed to rinse the given mouthwash four times per day preferably after oral hygiene. The examinations will be performed by one calibrated clinician.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811063182N1
Registration date:2010-06-06, 1389/03/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-06-06, 1389/03/16
Registrant information
Name
Keyvan Sohrabi Anaraki
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1882 9501
Email address
sohrabiak831@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2008-02-10, 1386/11/21
Expected recruitment end date
2010-01-01, 1388/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of Rosa damascena extract in the treatment of recurrent aphthous stomatitis: A randomized parallel controlled trial
Public title
The efficacy of Rosa damascena extract in the treatment of recurrent aphthous stomatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The presence of at least one aphthous ulcer measuring no more than 10 mm in diameter (formation no more than 48h), had no underlying systemic or immunologic disease such as rheumatoid arthritis and behcet syndrome. Patients were excluded if they had used NSAIDs, corticosteroids or other immunoregulatory agents within 1 month prior to the study or were less than 18 years of age.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences
City
Mashhad
Postal code
Approval date
2008-12-30, 1387/10/10
Ethics committee reference number
87464
Health conditions studied
1
Description of health condition studied
Recurrent aphthous stomatitis
ICD-10 code
K12.0
ICD-10 code description
Recurrent oral aphthae
Primary outcomes
1
Description
Change in Ulcer Size (mm2)
Timepoint
on day 0 (baseline), days 4, 7, 11 and 14
Method of measurement
Ulcer size is measured by one examiner with the use of a calibrated dental probe with millimeter markings.
2
Description
Change in number of Apthae
Timepoint
on day 0 (baseline), days 4, 7, 11 and 14
Method of measurement
Only ulcers which would come into contact with the rinse (i.e. in the oral cavity) will be considered.
3
Description
Change in Pain
Timepoint
on day 0 (baseline), days 4, 7, 11 and 14
Method of measurement
the Perceived Pain Rating Scale as introduced by Barker et al, 1991
Secondary outcomes
empty
Intervention groups
1
Description
Placebo
Category
Placebo
2
Description
Rosa damascena extract 20%, 4 times per day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry, Mashhad University of Medical Sciences
Full name of responsible person
Dr H.Hoseinpour
Street address
Vakil abad Ave, Oral Medcine Department
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Dr Tavakol Afshari
Street address
Daneshgah St.
City
Mashhad
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, Mashhad 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
Mashahd University of Medical Sciences
Full name of responsible person
Keyvan Sohrabi
Position
DDS/Dentistry
Other areas of specialty/work
Street address
School of Dentistry
City
Mashhad
Postal code
91735
Phone
+98 51 1882 9501
Fax
Email
k1sohrabi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad university of medical sciences
Full name of responsible person
Dr H.Hoseinpour
Position
Associate professor / DDS, MS
Other areas of specialty/work
Street address
School of dentistry, Departement of oral medicine
City
Mashhad
Postal code
91735
Phone
+98 51 1882 9501
Fax
Email
HoseinpourH@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)