Evaluation of the efficacy of Alum mucosal adherent in management of wound size of Recurrent Aphthous Stomatitis in Hamadan dental faculty in comparison with placebo group
The aim of this study is determination of efficacy of alum in management of pain, size and duration of ulcer healing in subjects with oral Aphtous ulcer in comparison with Placebo. In this double blind experimental clinical trial , 50 patients 15 to 24 years old, with history of minor oral aphtous in buccal and labial mucosa that attendant to oral medicine department of Hamadan dental faculty and volunteer students will be selected. The base of mucosal adherent in both groups include gum tragacanth, Alchohol, Water, and Sodium Benzoat. In study group Alum will be added to mucosal adherent. According to administration order, subjects should apply the adherent 3 times a day for 5 days in equal periods for 20 minutes on their aphtous ulcers. Subjects will be followed After one, three and five days. Healing criteria are size, pain and duration of healing of ulcers
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201305275678N2
Registration date:2014-06-12, 1393/03/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-12, 1393/03/22
Registrant information
Name
Hamidreza Abdolsamadi
Name of organization / entity
Faculty of dentistry
Country
Iran (Islamic Republic of)
Phone
+98 81 1822 7115
Email address
abdolsamadi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Science
Expected recruitment start date
2013-03-20, 1391/12/30
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
Evaluation of the efficacy of Alum mucosal adherent in management of wound size of Recurrent Aphthous Stomatitis in Hamadan dental faculty in comparison with placebo group
Public title
Evaluation of the efficacy of Alum in wound size of oral Aphthous
Purpose
Treatment
Inclusion/Exclusion criteria
Criteria for inclusion : people (male or female) over 15 years,The patient had a history of aphtous (at least 3 times a year), have a lesion less than 10 mm diameter,This ulcer must be in the areas of the mouth, which can be easily used in medicine including the tongue, floor of the mouth and the lining of the cheek Mucosa, lbial. should be a maximum of 3 days begining of new lesions (new lesion) ,no history of tratment
Exclusion criterias:pregnancy or lactating subjects ,patients with systemic diseases associated withAphtous like Cron,Rhiter and Behcet's disease ,consumption of chewable tobacco or cigarettes and ,Viral and fungal diseases , treatment with any other drug, consumption of acetaminophen and NSAID'S orantihistamine or another medication to treat thelesions, oral surgery over the past two weeks , orthodontic wire and bracket or restorative treatment
Age
From 15 years old to 30 years old
Gender
Both
Phase
N/A
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice President for research and technology
Street address
Hamedan- University of medical sciences
City
Hamedan
Postal code
65178-38677
Approval date
2013-05-02, 1392/02/12
Ethics committee reference number
16/35/9/286/پ/د
2
Ethics committee
Name of ethics committee
Vice President for research and technology
Street address
Hamedan-university of medical sciences
City
Hamedan
Postal code
65178-38677
Approval date
2013-05-02, 1392/02/12
Ethics committee reference number
16/35/9/286/پ/د
Health conditions studied
1
Description of health condition studied
recurrent aphtous stomatitis
ICD-10 code
k12.0
ICD-10 code description
Recurrent oral aphthae
Primary outcomes
1
Description
the size of the wound
Timepoint
days1,3,5
Method of measurement
ruler
Secondary outcomes
1
Description
the intensity of the pain
Timepoint
days 1,3,5
Method of measurement
visual analogue scale
Intervention groups
1
Description
Case group:"Aplication of mucous Adhesives containing alum"
Control group: "Application ofadhesive without alum(placebo) "
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
dental faculty
Full name of responsible person
Dr hamidrezaabdolsamadi
Street address
Hamedan_dentalfaculty
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
research center
Full name of responsible person
Dr Shahin Kasrayi
Street address
Hamadan dental faculty
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
research center
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 faculty-departmant of oral medicine
Full name of responsible person
Dr Shahrbanou Raedi
Position
assistant proffessor
Other areas of specialty/work
Street address
Hamadan dental faculty
City
Hamadan
Postal code
65178-38677
Phone
+98 81 1835 4016
Fax
Email
dr.radi80@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
dental faculty
Full name of responsible person
Dr Shahrbanou Raedi
Position
assistant proffessor
Other areas of specialty/work
Street address
Hamadan dental faculty
City
Hamadan
Postal code
Phone
+98 81 1835 4016
Fax
Email
dr.radi80@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
dental faculty
Full name of responsible person
dr Hamidreza Abdolsamadi
Position
associate proffessor
Other areas of specialty/work
Street address
Hamadan-dental faculty
City
Hamadan
Postal code
Phone
00
Fax
Email
Abdolsamadi@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)