Aphthous ulcer is one of the commonest oral cavity diseases with no known effective treatment so far which could cause severe discomfort in patients. Aloe vera (A.V.) is a tropical plant with anti-inflammatory and immunostimulant effects which could be of benefit in diversity of wounds healings conditions. The aim of this study is to evaluate topically administered A.V. gel on oral cavity aphthous healing. As a double blind clinical trial,40 patients would be treated by either placebo or A.V. oral gel. The healing time (days after gel application), patients pain score, the lesion and its surrounding inflammation diameters would be recorded for 2 weeks. After decoding the gel containers, AV treated group's results would be compared to placebo ones and P<0.05 would be statistically considered significant.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107277136N1
Registration date:2011-08-08, 1390/05/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-08-08, 1390/05/17
Registrant information
Name
Ebrahim Zabihi
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 4650
Email address
e.zabihi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
Expected recruitment start date
2010-04-04, 1389/01/15
Expected recruitment end date
2011-02-01, 1389/11/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of therapeutic effects of Aloe vera gel on minor recurrent aphthous stomatitis (RAS)
Public title
Therapeutic effects of Aloe Vera on canker sore
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1) Written consent
2) Age between 15-35
3) No systemic or oral cavity diseases except for RAS
4) Having singular minor recurrent aphtous on inner lips or cheeks since less than 48 h ago
Exclusion Criteria:
1) Refusing to give written consent
2) Having any systemic or oral cavity diseases other than RAS minor
3) Aphthous stomatitis (major)
4) Having multiple RAS lesions in oral cavity
5) Pregnancy
6) Smoking
Age
From 15 years old to 35 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Babol University of Medical Sciences ethics committee
Street address
BUMS, Ganje Afrooz avenue
City
Babol
Postal code
Approval date
2008-02-20, 1386/12/01
Ethics committee reference number
2436
Health conditions studied
1
Description of health condition studied
Recurrent aphthous stomatitis
ICD-10 code
K12.0
ICD-10 code description
Aphthous stomatitis (minor)r
Primary outcomes
1
Description
Stimulated pain score after
Timepoint
daily
Method of measurement
Visual Analogue Score
2
Description
Lesion and its surrounding inflammation diameters
Timepoint
Days: 0, 1, 3, 7 and 10
Method of measurement
Visual measurement using a metal caliper
Secondary outcomes
1
Description
Healing period
Timepoint
end of treatment
Method of measurement
VAS <2 and lesions less than 1 mm diameter
Intervention groups
1
Description
Administration of Aloe-Vera oral gel (2%):
Using 50 ml pump-cap polystyrene containers the gel would be applied on the lesions 3 times a day for at least 10 days
Category
Treatment - Drugs
2
Description
Administration of Placebo (Lubricant oral gel containing 2% normal saline): Using 50 ml pump-cap polystyrene containers the placebo gel would applied on the lesions 3 times a day for at least 10 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol University of Medical Sciences, School of Dentistry
Full name of responsible person
Dr Ebrahim Zabihi
Street address
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research; Babol University of Medical Sciences
Full name of responsible person
Dr Neda Babaee
Street address
School of Dentistry
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research; Babol 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
Babol University of Medcial Sciences
Full name of responsible person
Dr Zabihi
Position
Lecturer/PharmD,PhD
Other areas of specialty/work
Street address
Dept. of oral medecine and diagnosis Dental faculty, Babol Medical Sciences University, Ganjafrooz Ave. 47176, Babol, Iran
City
Babol
Postal code
Phone
+98 11121995915
Fax
Email
e.Zabihi@mubabol.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dept. of oral medecine and diagnosis Dental faculty, Babol Medical Sciences University
Full name of responsible person
Dr Neda Babaee
Position
Lecturer/DDS,MS
Other areas of specialty/work
Street address
School of Dentistry,
City
Babol
Postal code
Phone
+98 11 1229 1408
Fax
Email
n.babaee@mubabol.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Medicine
Full name of responsible person
Dr Zabihi
Position
Lecturer/Pharmacologist
Other areas of specialty/work
Street address
School of Medicine, Babol UMS
City
Babol
Postal code
Phone
+98 11121995910
Fax
Email
e.zabihi@mubabol.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)