Oral lichen planus (OLP) is a common oral mucous autoimmune disease with unknown etiology.The most commonly used topical and systemic therapies including corticosteroid is triamcinolone. Since long-term use of systemic corticosteroids have many side effects (including suppression of the immune system, increase their osteoporosis and fractures). In this study, it became that of bovine colostrum include growth factors, antimicrobial and immune factors (such as INF-γ, IL-6, IL-1β, etc.) and its beneficial effects on OLP and other immunological diseases has been demonstrated in case reports on the erosive OLP lesions we studied.
Designing:Phase 2 randomized double-blind, without placebo-controlled trials.
Inclusion criteria:
patients with erosive oral lichen planus.
Exclusion criteria :
taking any medication lichenoied; any other oral lesions (such as Lichenoid reaction).
Sample size:40.
Methods: this is a bovine Colostrum are provided to patients. (4 times a day and each time for 2 min, 5 ml in the mouth gargle).Also, patients treated with triamcinolone acetonide is also called the drug four times daily for 4 weeks and the lesion can be localized and 10 minutes after taking both drugs, avoid the eating and drinking and brushing. All patients refer to again after two weeks and four weeks after treatment to evaluate the lesion and the final questionnaire are presented. Clinical evaluation of measuring the extent of the lesion by lesion graded paper using a ruler to measure 100 mm segmentation is done. Pain and burn patients who are determined by the VAS scale is done.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109197594N1
Registration date:2012-09-04, 1391/06/14
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-09-04, 1391/06/14
Registrant information
Name
Mohammadreza Ebrahimpour
Name of organization / entity
School of Dentistry, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1229 8247
Email address
ali_e66110@yahoo.com
Recruitment status
Recruitment complete
Funding source
Research Deputy of Tehran University of Medical Sciences
Expected recruitment start date
2012-10-21, 1391/07/30
Expected recruitment end date
2012-11-20, 1391/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the efficacy of bovine colostrum with topical triamcinolone acetonide 0/1% in the treatment of erosive oral lichen planus.
Public title
comparison the efficacy of bovine colostrum with topical triamcinolone acetonide 0/1%
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with erosive oral lichen planus; lack of effective systemic drugs for at least three months of oral lichen planus and lack of effective topical medications for at least a month of oral lichen planus.
Exclusion criteria: systemic disease; taking any medication lichenoied and consumption of any tobacco.
Age
From 40 years old to 70 years old
Gender
Both
Phase
2
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
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
سامانه پژوهشیار دانشگاه علوم پزشکی تهران
Secondary trial Id
90-04-69-14575
Registration date
1390-04-17, 773/01/-1432
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran - Qods Avenue - Education Building of Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2012-07-03, 1391/04/13
Ethics committee reference number
90-4-69-14575-59013
Health conditions studied
1
Description of health condition studied
oral lichen planus
ICD-10 code
L43
ICD-10 code description
Lichen planus
Primary outcomes
1
Description
Clinical extent of the lesion
Timepoint
Before Intervention- after two weeks Intervention -after four weeks Intervention
Method of measurement
Ruler (per square millimeter)
Secondary outcomes
1
Description
Pain
Timepoint
Before Intervention- after two weeks Intervention -after four weeks Intervention
Method of measurement
According to statements made by the patient (by scale VAS)
2
Description
Burning sensation
Timepoint
Before Intervention- after two weeks Intervention -after four weeks Intervention
Method of measurement
According to statements made by the patient (by scale VAS)
Intervention groups
1
Description
Intervention group:
Five ml of pasteurized bovine colostrum under standard conditions between patients in the distribution of sterile vial and instructions for its use, both in writing and orally to patients placed.(4 times a day and each time for 2 min, 5 ml in the mouth gargle). Meanwhile, 10 minutes after taking drug,avoid the eating and drinking, and brushing.All patients refer again after two weeks and four weeks after treatment to evaluate the lesion and to complete the final questionnaire
Category
Treatment - Drugs
2
Description
control group:
This group of patients treated with triamcinolone acetonide is also called the drug four times daily for 4 weeks and the lesion can be localized.Meanwhile, 10 minutes after taking drug,avoid the eating and drinking, and brushing.All patients refer again after two weeks and four weeks after treatment to evaluate the lesion and to complete the final questionnaire.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Oral Diagnosis, Dental School, Tehran University of Medical Sciences
Full name of responsible person
Mohammadreza Ebrahimpour
Street address
iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Miss.Alamdar
Street address
Tehran - Qods Avenue - Education Building of Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
School of Dentistry, Tehran University of Medical Sciences
Full name of responsible person
Mohammadreza Ebrahimpour
Position
Final year PhD student at the General Dental
Other areas of specialty/work
Street address
Amir Abad Street, North End - after the Atomic Energy - Faculty of Dentistry Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 913 329 1873
Fax
Email
ali_e66110@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Dentistry, Tehran University of Medical Sciences
Full name of responsible person
Dr. Mahnaz Sahebjamie
Position
Mouth disease specialist
Other areas of specialty/work
Street address
Amir Abad Street, North End - after the Atomic Energy - Faculty of Dentistry Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 912 306 3270
Fax
Email
sahebjam@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Dentistry, Tehran University of Medical Sciences
Full name of responsible person
Mohammadreza Ebrahimpour
Position
Final year PhD student at the General Dental
Other areas of specialty/work
Street address
Amir Abad Street, North End - after the Atomic Energy - Faculty of Dentistry Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 913 329 1873
Fax
Email
ali_e66110@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)