Aim of the study: Comperative study of muco-adhesive patch containing 0.01 mg Triamcinolone with placebo in symptomatic treatment of Minor Oral Aphthous ulcer.
Inclusion and exclusion crieteria:presence of Minor oral Aphthous ulcer- No history of any systemic disease and no previous application of any drug for treatment of aphtea.
Population study: In this double blind clinical trial ,a mucco-adhesive with dual aims of dressing meanwhile concentration of drug on Aphthous ulcer ,have been manufactured by adding Triamcinolone to mucco-adhesive base and applied to 40 patients.From 23 of them who took part in all three appointment with three days interval. 14 recieved drug and 9 recieved placebo.,amount of pain evaluated by Visual analogue scale and maximum diameter of ulcer were measured by millimeter.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111057999N1
Registration date:2011-12-12, 1390/09/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-12-12, 1390/09/21
Registrant information
Name
Gholamreza jahanshahi
Name of organization / entity
Isfahan university of medical sciences-school of dentistry
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2879
Email address
jahanshahi@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences-Shool of Dentistry-Vice chancellor of research
Expected recruitment start date
2009-06-22, 1388/04/01
Expected recruitment end date
2011-01-21, 1389/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of Muco-adhesive (Aphtogel) in treatment of oral minor Aphthous ulcer with placebo
Public title
study of Aphtogel in treatment of oral aphthea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: presence of minor oral apththous ulcer; Age of patients between 20 -60 years; completion of the consence form by the patient
Exclusion criteria: patient age less than 20 years or more than 60 years; History of any systemic disease; previous consumption of another drug for treatment of aphtea
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
23
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,Azadi Square,Isfahan, Iran
City
Isfahan
Postal code
8174673461
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
24604/4/12/پ
2
Ethics committee
Name of ethics committee
Ethic Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences,Azadi Square,Isfahan, Iran
City
Isfahan
Postal code
81747-73461
Approval date
2009-06-07, 1388/03/17
Ethics committee reference number
24604/4/12/پ
Health conditions studied
1
Description of health condition studied
Minor Oral Aphthous Ulcer
ICD-10 code
k12.5
ICD-10 code description
Recurrent oral aphthae
Primary outcomes
1
Description
Amount of pain
Timepoint
Three days interval
Method of measurement
Visual analouge scale
2
Description
Size of Ulcer
Timepoint
Three days interval
Method of measurement
Milimeter Ruler
Secondary outcomes
1
Description
Decrease of pain
Timepoint
Three days interval
Method of measurement
visual analouge scale
2
Description
Decrease in size of ulcer
Timepoint
Three days interval
Method of measurement
Milimeter ruler
Intervention groups
1
Description
Applying of Aphtogel with 0.01 mg Triamcinolone on the ulcer 4 times a day for 1 week
Category
Treatment - Drugs
2
Description
Applying of Aphtogel without Triamcinolone on the ulcer 4 times a day for 1 week