Protocol summary

Summary
The goal of this study is evaluation of the Montelukast and Prednisone therapeutic effect simultaneously in patients with Oral Lichen Planus (OLP). If this research will be successful, we can reduce corticosteroid dosage, and decrease its side effects. In addition, we can achieve desirable consequences with low adverse effects of Montelukast. Two hundreds patients with erosive oral lichen planus (middle aged males and females) will be selected and diagnosis of all patients will be carried out by clinical sings and biopsy. Inclusion criteria: (1) Diagnosis of OLP will be carried out by clinical history, physical exams and histopathological findings. (2) All of the patients should not use medication for at least two months. (3) They should not have systemic diseases such as diabetes mellitus, hepatitis and trauma history. Exclusion criteria : Patient is non-compliant with treatment until end of study. In this randomized double blinded study ( the practitioner and patient do not know the therapeutic process) , the patients divided into two groups randomly ; Group A : daily 20 milligrams (mg) oral Prednisone for 15 days and then 12.5 mg for 15 days and 6.25 mg alternate day for 15 days . Group B : Prednisone similar to group A and 10 mg oral Montelukast daily for first month and then 10 mg Montelukast alternate day for second month. For patients in group A, as well as Prednisone, placebo will be prescribed similar to Montelukast and with same administration. The lesion size with ruler or flexible surgical probe and pain quantity with Visual Analogue Scaling (VAS) will be recorded before treatment and every 2 weeks after treatment for 3 months. Failure of treatment will been defined with lack of clinical improvement for at least three months period. One hundred patients with erosive oral lichen planus (middle aged males and females) will be selected and diagnosis of all patients will be carried out by clinical sings and biopsy. Inclusion criteria: (1) Diagnosis of OLP will be carried out by clinical history, physical exams and histopathological findings. (2) All of the patients should not use medication for at least two months. (3) They should not have systemic diseases such as diabetes mellitus, hepatitis and trauma history. Exclusion criteria : Patient is non-compliant with treatment until end of study. In this randomized single blinded study (only the practitioner knows the therapeutic process) , the patients divided into two groups randomly ; Group A : daily 20 milligrams (mg) oral Prednisone for 15 days and then 12.5 mg for 15 days and 6.25 mg alternate day for 15 days . Group B : Prednisone similar to group A and 10 mg oral Montelukast daily for first month and then 10 mg Montelukast alternate day for second month. For patients in group A, as well as Prednisone, placebo will be prescribed similar to Montelukast and with same administration. The lesion size with ruler or flexible surgical probe and pain quantity with Visual Analogue Scaling (VAS) will be recorded before treatment and every 2 weeks after treatment for 3 months. Failure of treatment will been defined with lack of clinical improvement for at least three months period.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012110811389N2
Registration date: 2012-12-24, 1391/10/04
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-12-24, 1391/10/04
Registrant information
Name
Poorandokht Davoodi
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1252 5189
Email address
p.davoodi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Hamedan University of Medical Sciences
Expected recruitment start date
2013-01-04, 1391/10/15
Expected recruitment end date
2013-03-05, 1391/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of therapeutic effect of Montelukast and Prednison in patients with oral lichen planus
Public title
Therapeutic effect of Montelukast in patients with oral lichen planus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : (1) Diagnosis of OLP will be carried out by clinical history , physical exams and histopathological findings. (2) All of the patients should not use medication for at least two months. (3) They should not have systemic diseases such as diabetes mellitus, hepatitis and trauma history. Exclusion criteria : Patient is non-compliant with treatment until end of study.
Age
From 40 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
single blinded: only the practitioner knows the therapeutic process . Randomization : Stratified - Blocking

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamedan University of Medical Sciences
Street address
Vice Chancellor for research , Hamedan University of Medical Sciences , Shahid Fahmideh St. , Hamedan , Iran
City
Hamedan
Postal code
65178
Approval date
2012-08-13, 1391/05/23
Ethics committee reference number
D/P/16/35/9/2320

Health conditions studied

1

Description of health condition studied
Lichen Planus
ICD-10 code
L43
ICD-10 code description
Lichen Planus

Primary outcomes

1

Description
Size of lesion
Timepoint
Study onset/after 2,4,6,8,10,12 weeks
Method of measurement
Ruler or flexible surgical probe

2

Description
Pain rate
Timepoint
Study onset/after 2,4,6,8,10,12 weeks
Method of measurement
Visual Analogue Scaling

Secondary outcomes

empty

Intervention groups

1

Description
Montelukast , 10 milligrams oral tablet , first month : daily, one tablet and second month : alternate day, one tablet
Category
Treatment - Drugs

2

Description
Placebo ,10 milligrams oral tablet , similar motelukast , first month : daily , one tablet and second month : alternate day , one tablet
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Hamedan Dentistry Faculty
Full name of responsible person
Hossein Hasannia
Street address
Dentistry Faculty , Hamedan University of Medical Sciences , Shahid Fahmideh St. , Hamedan , Iran
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research , Hamedan University of Medical Sciences
Full name of responsible person
Heydar Tavilani
Street address
Vice Chancellor for Research , Hamedan University of Medical Sciences , Shahid Fahmideh St. , Hamedan , Iran
City
Hamedan
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 , Hamedan 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
Hamedan Dentistry Faculty
Full name of responsible person
Hossein Hasannia
Position
Postgraduate Student of Oral Medicine
Other areas of specialty/work
Street address
Dentistry Faculty ، Hamedan University of Medical Sciences , Shahid Fahmideh St. , Hamedan , Iran
City
Hamedan
Postal code
6517774433
Phone
+98 81 1839 0936
Fax
+98 81 1845 4140
Email
dr_hossein78@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan Dentistry Faculty
Full name of responsible person
Poorandokht Davoodi
Position
Assistant Professor
Other areas of specialty/work
Street address
Dentistry Faculty ,Hamedan University of Medical Sciences , Shahid Fahmideh St. , Hamedan , Iran
City
Hamedan
Postal code
6517838677
Phone
+98 81 1825 0998
Fax
+98 81 1835 4016
Email
p.davoodi@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamedan Dentistry Faculty
Full name of responsible person
Poorandokht Davoodi
Position
Assistant Professor
Other areas of specialty/work
Street address
Dentistry Faculty , Hamedan University of Medical Sciences , Shahid Fahmideh St. , Hamedan , Iran
City
Hamedan
Postal code
6517838677
Phone
+98 81 1825 0998
Fax
+98 81 1835 4016
Email
p_davoodi@umsha.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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