The purpose this study is to evaluate the effects of nut meg biogel on recurrent aphthous stomatitis .This is a randomized ,double - blind ,crossover clinical trial. Inclusion criteria:People with a history of minor oral aphthous lesions in the mucosa of the cheek or lip,at least fourPeriods per year ؛ The age group 18 to 50 years. Exclusion criteria:minor or multiple minor aphthous ulcers ؛ ulcers in other sites expect labial and buccal mucosa ؛ present of any systemic diseases that developed oral ulcers ؛ bechet disease؛ hematologic diseases ؛ taking chemotherapic drugs؛ pregnant and nursing weman.20 patients with recurrent aphthous stomatitis history are selected from the students of Babol university of medical sciences and patients referred to oral medicine department ,school of dentistry, Babol university of medical sciences. Each patient is monitored in four periods of aphthous ulcers and one period without treatment and just monitoring the ulcer and three periods with taking one of biogel, triamcinolone or nut meg biogel randomly .All patients are visited in 1st, 3rd, 5th, 7th and 10th days at each period.Primary outcomes include:Pain intensity(VAS) and ulcer size.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201603149271N5
Registration date:2016-05-05, 1395/02/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-05, 1395/02/16
Registrant information
Name
Ali Akbar Moghadamnia
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1222 9591
Email address
a.moghadamnia@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect nut meg biogel on recurrent aphthous
stomatitis
Public title
Evaluation the effect of nut meg biogel on oral minor aphthous.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:People with a history of minor oral aphthous lesions in the mucosa of the cheek or lip,at least four courses per year ؛ The age group 18 to 50 years . Exclusion criteria:minor or multiple minor aphthous ulcers ؛ulcers in other sites expect labial and buccal mucosa؛ present of any systemic diseases that develope oral ulcers such as gastrointestinal disorders (crohn disease, ulcerative colitis)؛ bechet disease؛ Reiter syndrome؛ hematologic diseases؛malnutrition؛ allergic condition؛ consumption of chemotrapic drugs ؛immunosupressive or systemic corticosteroids at past year؛ patients with any other mucosal؛ pregnant and nursing woman.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University of Medical Sciences, Deputy of research & technology
Street address
University of Medical Sciences, Ganjafroz Street, Babol
City
Babol
Postal code
4717641367
Approval date
2015-10-26, 1394/08/04
Ethics committee reference number
MUBABOL.REC.1394.160
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
ulcer size
Timepoint
1st, 3rd, 5th, 7th and 10th days
Method of measurement
gauge measurement
2
Description
pain intensity
Timepoint
firth, third,fifth,seventh and tenth days
Method of measurement
visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Nut meg biogel 3 times a day until recovery
Category
Treatment - Drugs
2
Description
Triamcinolone biogel 3 times a day until recovery
Category
Treatment - Drugs
3
Description
biogel 3 times a day until recovery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol University of Medical Sciences, Department of Oral Medicine
Full name of responsible person
Simin Noori khanghah
Street address
Babol University of Medical Sciences, Ganjafroz Street, Babol
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Ali Bijani
Street address
University of Medical Sciences, Ganjafroz Street, Babol
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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 Medical Sciences
Full name of responsible person
Ali Akbar Moghadamnia
Position
proffesor
Other areas of specialty/work
Street address
University of Medical Sciences, Ganjafroz Street, Babol
City
Babol
Postal code
4717641367
Phone
+98 11 3219 7667
Fax
Email
moghadamnia@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Medical Sciences
Full name of responsible person
Ali Akbar Moghadamnia
Position
proffesor
Other areas of specialty/work
Street address
University of Medical Sciences, Ganjafroz Street, Babol
City
Babol
Postal code
4717641367
Phone
+98 11 3219 7667
Fax
Email
moghadamnia@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Ali Akbar Moghadamnia
Position
Proffesor
Other areas of specialty/work
Street address
University of Medical Sciences, Ganjafroz Street, Babol
City
Babol
Postal code
Phone
+98 11 3219 7667
Fax
Email
moghadamnia@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)