Evaluation of the effect of mucoadhesive containing mulberry (Morus nigra L.) fruit juice for treatment of minor recurrent aphthous stomatitis compared with placebo: a double blind randomized clinical trial
The aim of this study is evaluation of the effect of mulberry fruit juice for treatment of minor recurrent aphthous stomatitis. this study is a randomized double blind clinical trial on 40 patients over 18 years of age with recurrent oral aphthous ulcer. The patients referring to the Department of oral and maxillofacial diseases, Faculty of Dentistry, Mazandaran University of Medical Sciences, will be divided into 2 groups of drug and placebo. All the patients will be instructed to use one mucoadhesive three times a day (morning, noon and evening) for seven days. the severity of pain by Visual Analogue Scale (VAS) and also the diameter of the ulcer with inflammatory halo by periodontal probe will be measured on days zero, three, five and seven after starting the treatment. Finally, The data will be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017031129802N2
Registration date:2017-09-04, 1396/06/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-04, 1396/06/13
Registrant information
Name
Somayeh Shahani
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3354 3761
Email address
s.shahani@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Mazandaran University of Medical Sciences
Expected recruitment start date
2016-08-23, 1395/06/02
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of mucoadhesive containing mulberry (Morus nigra L.) fruit juice for treatment of minor recurrent aphthous stomatitis compared with placebo: a double blind randomized clinical trial
Public title
Evaluation of mulberry juice in treatment of oral aphthous ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Patients with minor aphthous stomatitis; over 18 years old. Exclusion criteria:major and recurrent stomatitis herpetiformis; patients who have aphthous ulcers other than buccal mucosa and lips; having systemic disease; those taking immunosuppressant drugs during the past month; denture wearers; recipients of antibiotics; pregnant patients; people who are not able to use the mucoadhesive; aphthous ulcers which are the manifestation of a syndrome (Behcet); smokers and those who can not complete the study until the end due to personal or social causes.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
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
Randomization: Patients will be randomly divided into two groups of drug and placebo using a random number table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Moallem Square
City
Sari
Postal code
Approval date
2016-08-22, 1395/06/01
Ethics committee reference number
IR.MAZUMS.REC.95.2080
Health conditions studied
1
Description of health condition studied
Recurrent aphthous ulcer
ICD-10 code
K12.0
ICD-10 code description
Recurrent oral aphthae
Primary outcomes
1
Description
Severity of pain
Timepoint
Zero, three, five and seven days after the treatment
Method of measurement
Visual Analogue Scale
2
Description
The total size of the ulcer with erythmatous halo
Timepoint
Zero, three, five and seven days after the treatment
Method of measurement
Periodontal probe
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Mucoadhesive with mulberry juice, three times a day for seven days
Category
Treatment - Drugs
2
Description
Intervention group 2: Mucoadhesive without medicine, three times a day for seven days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Maedeh Salehi
Street address
Department of oral and maxillofacial diseases, Faculty of Dentistry, Khazar Blvd.
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Ahmad Ali Enayati
Street address
Vice Chancellor for Research and Technology, Moallem square
City
Sari
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 and Technology, Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Somayeh Shahani
Position
Assistant Professor, Department of Pharmacognosy and Biotechnology
Other areas of specialty/work
Street address
Faculty of Pharmacy, Mazandaran University of Medical Sciences, Km 18 of Khazarabad Road
City
Sari
Postal code
Phone
+98 11 3354 3761
Fax
Email
so.shahani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Somayeh Shahani
Position
PhD of Pharmacognosy
Other areas of specialty/work
Street address
Department of Pharmacognosy and Biotechnology, Faculty of Pharmacy,Mazandaran University of Medical Sciences, Km 18 of Khazarabad Road
City
Sari
Postal code
48471-93698
Phone
+98 11 3354 3761
Fax
Email
so.shahani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Somayeh Shahani
Position
PhD of Pharmacognosy
Other areas of specialty/work
Street address
Department of Pharmacognosy and Biotechnology, Faculty of Pharmacy,Mazandaran University of Medical Sciences, Km 18 of Khazarabad Road
City
Sari
Postal code
48471-93698
Phone
+98 11 3354 3761
Fax
+98 11 3354 3084
Email
so.shahani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)