In the present study, the effect of mucoadhesive containing licorice extract on pain reduction and accelerating recovery of aphthous ulcers is reviewed. This study is randomized, double-blind and placebo controlled. The studied population is chosen among the referrers to oral and maxillofacial diseases division of faculty of dentistry of Mazandaran university of medical sciences in 2016/1395 and they will consciously sign the testimonial/disclaimer form. This clinical trial is performed on 18+ year-old patients with recurrent oral aphthous. The studied people will be randomly divided into two groups of “control” and “intervention”. The control group will get the mucoadhesive without the medication and the intervention group will get the mucoadhesive with licorice extract. The patients will be asked to use the mucoadhesive 3 times a day for a week. The patients` pain level will be recorded by themselves and the diameter of the ulcer with inflammatory halo will be recorded by the project executors using a periodontal probe in clinic. and in the end the results out of both of the groups will be compared to each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017031333046N1
Registration date:2017-04-16, 1396/01/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-16, 1396/01/27
Registrant information
Name
Aliakbar Sharifian
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3388 5621
Email address
asharifian89@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, mazandaran university of medical science
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluate the effectiveness of licorice extract to improve recurrent aphthous stomatitis (RAS)
Public title
effectiveness of licorice to improve aphthae
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Minimum age 18 years; have sufficient knowledge and literacy, oral aphthous ulcers. Exclusion criteria: major and recurrent stomatitis herpetiformis; aphthous ulcers and other patients who have the buccal mucosa and lips; 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 ulcer syndrome is that it is one presentations (Behcet); smokers and those who can not study continue until the end due to personal or social causes.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
42
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
The ethics committee of Mazandaran University of Medical Sciences
Street address
Vice chancellor for research, Mazandaran university of medical science, The martyr Motahhari square, Street teacher
City
Sari
Postal code
Approval date
2016-11-29, 1395/09/09
Ethics committee reference number
IR.MAZUMS.REC.95.2303
Health conditions studied
1
Description of health condition studied
Recurrent aphthous ulcers
ICD-10 code
K12.0
ICD-10 code description
recurrent aphthous stomatitis
Primary outcomes
1
Description
severity of pain
Timepoint
48 hours
Method of measurement
visual analoge scale
2
Description
The total size of the wound with erythematous halo
Timepoint
48 hours
Method of measurement
Periodontal probe
Secondary outcomes
empty
Intervention groups
1
Description
Mucosal Adhesive 3 times a day for seven days
Category
Placebo
2
Description
Mucous adhesive containing licorice extract three times a day for seven days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Clinic, Mazandaran University of Medical Sciences
Full name of responsible person
Maedeh Salehi
Street address
Dental clinic, Khazar Blvd, Khazar square
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
Vice chancellor for research, The martyr Motahhari square, Street teacher
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, 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
Tahereh Molania
Position
Professor / Associate Professor, School of Dentistry
Other areas of specialty/work
Street address
Dental clinic, Khazar Blvd, Khazar square
City
Sari
Postal code
Phone
+98 11 3330 2908
Fax
Email
T_molania117@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
Maedeh Salehi
Position
Professor / Associate Professor, School of Dentistry
Other areas of specialty/work
Street address
Dental clinic, Khazar Blvd, Khazar square
City
Sari
Postal code
Phone
+98 11 3330 2908
Fax
Email
salehimaede1165@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Maedeh Salehi
Position
Expert mouth disease diagnosis / Associate Professor, Faculty of Dentistry University of Medical Sci
Other areas of specialty/work
Street address
Dental clinic, Khazar Blvd, Khazar square
City
Sari
Postal code
Phone
+98 11 3330 2908
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)