Recurrent aphthous stomatitis (RAS) is a common , painful and ulcerative disorder of oral cavity with unknown etiology . No cure exists and topical application of medications aims to reduce pain associated with this condition. The aim of this study was to evaluate the efficacy of Punica granatum (PG) extract on the management of RAS. Fourty patients with RAS participated in this randomized, double-blind, placebo-controlled study. During three episodes of RAS the efficacy of topical PG gel 10% was evaluated. Patients were randomly assigned to use placebo gel or PG gel daily. The time of pain elimination and the duration of complete healing were recorded and the associated pain during this time span (day0, 1, 3, 5, 7) were recorded by patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112273251N2
Registration date:2012-02-07, 1390/11/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-02-07, 1390/11/18
Registrant information
Name
Atefeh Tavangar
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2814
Email address
tavangar@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vica-chancellery for research, Isfahan University of Medical Sciences
Expected recruitment start date
2007-03-25, 1386/01/05
Expected recruitment end date
2008-06-18, 1387/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Efficacy of Punica Granatum Extract in the Management of Recurrent Apthous Stomatitis
Public title
The Efficacy of Golnar on Recurrent Apthous Stomatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1-patients with minor aphthea; 2-active phase of ulcer (24-48 first hours). Exclusion critria: 1- patients with any systemic disease; 2-patients taking anti-inflammatory or analgesic drugs; 3- patients with major or herpetiform.
Age
From 18 years old to 47 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
34
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
Isfahan university of medical sciences
Street address
Isfahan university of medical sciences, vica-chancellary for research
City
Isfahan
Postal code
Approval date
2007-07-01, 1386/04/10
Ethics committee reference number
386229
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
pain
Timepoint
days 0, 1, 3, 5
Method of measurement
VAS
Secondary outcomes
1
Description
the time of complet healing ulcer
Timepoint
during active phase of RAS
Method of measurement
day
2
Description
the time of painless ulcer
Timepoint
during active phase of RAS
Method of measurement
day
Intervention groups
1
Description
Golnar, oral gel 10%,three times a day
Category
Treatment - Drugs
2
Description
placebo, frrous oxid oral gel, three times a day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
oral medicine part of school of dentistry, Isfahan university of medical sciences
Full name of responsible person
Atefeh Tavangar
Street address
Isfahan university of medical sciences, Hezarjerib street
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vica-chancellery for research of dentistry school
Full name of responsible person
Dr Omid Savabi
Street address
Vica-chancellery for research, Dentistry school, Isfahan University of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vica-chancellery for research of dentistry school
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
Isfahan University of Medical Sciences
Full name of responsible person
Atefeh Tavangar
Position
assistant professor of oral medicine
Other areas of specialty/work
Street address
Oral Medicine Department of dentistry school, Isfahan University of Medical Sciences
City
Isfahan
Postal code
8174673461
Phone
+98 31 1792 2815
Fax
+98 66 87080
Email
tavangar@dnt.mui.ac.ir , dr.tavangar_at@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Atefeh Tavangar
Position
Assistant Professor of Oral Medicine
Other areas of specialty/work
Street address
Oral Medicine Department of dentistry school, Isfahan University of Medical Sciences
City
Isfahan
Postal code
8174673461
Phone
+98 31 1230 4830
Fax
Email
tavangar@dnt.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Atefeh Tavangar
Position
Assistant Professor of Oral Medicine
Other areas of specialty/work
Street address
Oral Medicine Department of dentistry school, Isfahan University of Medical Sciences
City
Isfahan
Postal code
8174673461
Phone
+98 31 1792 2814
Fax
Email
tavangar@dnt.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)