Recurrent aphthous stomatitis (RAS) is the most common oral mucosal lesions in the general population. Various treatment modalities are being used; but no specific therapy proved to be definitive. Zingiber Officinale indicated to have anti-inflammatory properties in herbal medicine. Thus, this study aimed to evaluate the efficacy of Zingiber Officinale containing bioadhesive in treatment of aphthous ulcers. This is a double-blinded placebo randomized controlled trial study. Thirty patients enrolled in this study. Patients are randomly assigned in to two goups. All cases are evaluated during three aphthous periods for a minor aphthous stomatitis within the past 24h, confined to the lips and oral mucosa within each period. The clinical efficacy of the mucoadhessive patch or mouth wash on pain, inflammatory zone and ulcer's diameter in the test group will be compared with that of the base treatment and no treatment groups during 10 days of study. The patients will be asked to record the level of pain severity of the ulcers each day before meals and before bedtime through VAS (Visual Analogue Scale). The diameter of lesions and inflammatory zone will be measured and recorded in the profile of each case, by the examiner during the meetings at days 0, 1, 3, 5, 7 of the study. Eventually, to analyze the gathered data, SPSS ver. 18 will be employed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201311101760N27
Registration date:2014-01-22, 1392/11/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-01-22, 1392/11/02
Registrant information
Name
Nargess Gholizadeh Pasha
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 2282
Email address
zahra@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Expected recruitment start date
2013-12-16, 1392/09/25
Expected recruitment end date
2014-03-06, 1392/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Efficacy of the Mucoadhesive Patch and Mouthwash Containing Zingiber Officinale Extract in the Management of Recurrent Aphthous Stomatitis
Public title
The Efficacy of the Mucoadhesive Patch and Mouthwash Containing Zingiber Officinale Extract in the Management of Recurrent Aphthous Stomatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: minor pest record over the last 2 months.
Exclusion criterion: major and several minor aphthous ulcers or sores in other areas of the mucosa, lips and cheeks.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
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 Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafroz Road
City
Babol
Postal code
Approval date
2013-12-15, 1392/09/24
Ethics committee reference number
3461
Health conditions studied
1
Description of health condition studied
Oral Mucositis
ICD-10 code
K12.3
ICD-10 code description
Oral mucositis
Primary outcomes
1
Description
Minor aphthous ulcers
Timepoint
Seventh-day visit
Method of measurement
Clinical
Secondary outcomes
1
Description
Lesion diameter
Timepoint
Zero, first, third, fifth and seventh days of referral
Method of measurement
clinical
2
Description
Inflammatory halo size
Timepoint
Zero, first, third, fifth and seventh days of referral
Method of measurement
clinical
3
Description
Pain
Timepoint
Zero , first, third, fifth and seventh days of referral
Method of measurement
Visual Analoge Scale(VAS)
Intervention groups
1
Description
Intervention group:
During three aphthous are studied.The first blow to fall markedly during registration per person and two other courses of treatment with a mouthwash (Ethanol, 96% ethanol extract of Zingiber with ml 500 gr 300. Ginger powder is prepared in the laboratory of Pharmacology, Babol University of Medical Sciences.)containing ginger(Dried extract prepared at a concentration of 4%) are studied.
How to use sticky mucous and Mouthwash: Per day (after each meal and before bedtime) for 20 minutes.
How mouthwash: Condition with a tablespoon or a mouthwash bottles kept in the wound for 30 seconds and then removed from the mouth.It should be noted that the 7-day treatment until complete healing, patients are followed up and examined.
Category
Treatment - Drugs
2
Description
Control(placebo):
Based mouthwash (distilled water as a mouthwash base);Mucosal Adhesive Base (including gum (tragacanth), alcohol, sodium benzoate, and distilled water was prepared in the laboratory of Pharmacology, Babol University of Medical Sciences) for use sticky mucus and rinse in the day (after each meal and before bedtime) to for 20 minutes.
How to use sticky mucous and Mouthwash: Per day (after each meal and before bedtime) for 20 minutes.
How mouthwash: Condition with a tablespoon or a mouthwash bottles kept in the wound for 30 seconds and then removed from the mouth.It should be noted that the 7-day treatment until complete healing, patients are followed up and examined.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Oral Medicine, Dental College of Babol
Full name of responsible person
Dr. Masoomeh Haghpanah Aski
Street address
Dental College of Babol
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Bijani
Street address
Vice Chancellor for Research and Technology, Babol University of Medical Sciences, Ganjafroz Avenue
City
Babol
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, 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
Dental College of Babol
Full name of responsible person
Dr. Masoomeh Haghpanah Aski
Position
Postgraduate Periodontics
Other areas of specialty/work
Street address
Dental College, Babol University of Medical Sciences, Ganjafroz Avenue
City
Babol
Postal code
Phone
+98 11 1229 1408
Fax
Email
parya_haghpanah@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental College of Babol
Full name of responsible person
Dr. Mina Motallebnejad
Position
Associate Professor
Other areas of specialty/work
Street address
Dental College of Babol, Babol University of Medical Sciences, Gangafroz Avenue
City
Babol
Postal code
Phone
+98 11 1222 7667
Fax
Email
mmotallebnejad@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fatemehzahra Infertility & Reproductive Health Research Center
Full name of responsible person
Nargess Gholizadeh Pasha
Position
M.A/Responsible of Reseach Center
Other areas of specialty/work
Street address
City
Babol
Postal code
Phone
+98 11 1227 4881
Fax
+98 11 1227 4880
Email
ngh_pa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)