Objectives: To assess the effect of Propolis gel versus orabase gel (placebo) on treatment of lissions in patients with recurrent minor aphtous ulcer
Design: a double blind randomized clinical trial.
Setting and conduct: The eligible patients with recurrent minor aphtous ulcers who will refer to Hamadan Dentistry School during the study period will be enrolled into the trial.
Inclusion criteria: (a) age of 15 to 60 years; (b) having recurrent minor aphtous ulcers; (c) history of disease for more than one year with at least two recurrence a year; (d) having 1 to 6 ulceration if each episode; (e) less than 72 hours from the begging of the ulceration; (f) the duration of healing without medication is not more than 7 days; (g) the size of ulcers is not more than 1 cm.
Exclusion criteria: (a) hypersensitivity to drug or plant; (b) treatment with immunosuppressive drugs during the last month; (c) using systemic antibiotic during the last two weeks; (d) using anti-inflammatory drugs or anti-histamine during the last month; (e) using any drug for treatment of aphtous ulcers during the last 72 hours; (f) having systemic diseases such as endocrine, immunologic, hematologic, metabolic, rheumatoid arteritis, and hormonal disorders; (g) during pregnancy or breastfeeding; complete or partial denture or unsuitable restoration of a tooth or appliance ortodency in close contact with aphtous ulcers; (h) cigarette smoking or drinking alcohol; (i) affected with major aphtous ulcers or herpetiform ulcers.
Intervention: putting 1 cm in length of Propolis gel on aphtous ulcers 4 time a day for 6 days.
Control: putting 1 cm in length of orabase gel (placebo) on aphtous ulcers 4 time a day for 6 days.
Primary outcome: (a) measuring the pain severity before and 3 and 6 days after treatment by taking history; (b) measuring the diameter of lesions before and 3 and 6 days after treatment by physical examination.
Secondary outcome: presence of erythema or exudates 3 and 6 days after treatment by physical examination.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201411269014N49
Registration date:2014-12-02, 1393/09/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-02, 1393/09/11
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2014-11-26, 1393/09/05
Expected recruitment end date
2015-02-24, 1393/12/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Propolis gel versus placebo on wound treatment in patients with recurrent minor aphtous ulceration: a double-blind randomized clinical trial
Public title
Effect of Propolis gel versus placebo on wound treatment in patients with recurrent minor aphtous ulceration
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) age of 15 to 60 years; (b) having recurrent minor aphtous ulcers; (c) history of disease for more than one year with at least two recurrence a year; (d) having 1 to 6 ulceration if each episode; (e) less than 72 hours from the begging of the ulceration; (f) the duration of healing without medication is not more than 7 days; (g) the size of ulcers is not more than 1 cm.
Exclusion criteria: (a) hypersensitivity to drug or plant; (b) treatment with immunosuppressive drugs during the last month; (c) using systemic antibiotic during the last two weeks; (d) using anti-inflammatory drugs or anti-histamine during the last month; (e) using any drug for treatment of aphtous ulcers during the last 72 hours; (f) having systemic diseases such as endocrine, immunologic, hematologic, metabolic, rheumatoid arteritis, and hormonal disorders; (g) during pregnancy or breastfeeding; complete or partial denture or unsuitable restoration of a tooth or appliance ortodency in close contact with aphtous ulcers; (h) cigarette smoking or drinking alcohol; (i) affected with major aphtous ulcers or herpetiform ulcers.
Age
From 15 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: random assignment of the patients systematically one at a time to intervention and control groups.
Blinding: both propolis gel versus orabase gel (placebo) will be prepared in dark and similar containers thus patients will not be aware of the type of treatment they receive. In addition, the examiner who will examine the patients is another person that will not be aware of the type of intervention. Therefore, the trial will be run as double blinded.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2014-11-25, 1393/09/04
Ethics committee reference number
D/P/16/35/9/4184
Health conditions studied
1
Description of health condition studied
aphtous ulcers
ICD-10 code
K12.0
ICD-10 code description
Recurrent oral aphthae
Primary outcomes
1
Description
measuring the diameter of lesions
Timepoint
before and 3 and 6 days after treatment
Method of measurement
by physical examination
2
Description
measuring the pain severity
Timepoint
before and 3 and 6 days after treatment
Method of measurement
by taking history
Secondary outcomes
1
Description
presence of erythema or exudates
Timepoint
3 and 6 days after treatment
Method of measurement
by physical examination
Intervention groups
1
Description
putting 1 cm in length of Propolis gel on aphtous ulcers 4 time a day for 6 days
Category
Treatment - Drugs
2
Description
putting 1 cm in length of orabase gel (placebo) on aphtous ulcers 4 time a day for 6 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry School
Full name of responsible person
Azadeh Moslemkhani
Street address
Dentistry School, Shahid Fahmideh Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
Dentistry School
Full name of responsible person
Azadeh Moslemkhani
Position
Dentistry student
Other areas of specialty/work
Street address
Dentistry School, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 1086
Fax
Email
freebird_a90@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dentistry School
Full name of responsible person
Dr Sharmin Abdollahzadeh
Position
Oral disease specialist
Other areas of specialty/work
Street address
Dentistry School, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 1086
Fax
Email
shery13562002@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)