In this study we decided to compare the anti-inflammatory effects of Triamcinolone Acetonide 0.1% with nanoliposomal carriers formulation in Orabase and the common formulation of Triamcinolone Acetonide 0.1% in Orabase on referral patients with oral Lichen Planus to Oral Medicine Department of Dental Branch, Islamic Azad University of Tehran in 2013-2014.
This study is performing in the manner of double blind (for investigators and patients) randomized clinical trial and in a single center on 40 patients with erythematous-ulcerative oral Lichen Planus.
Inclusion criteria are all patients with symptomatic oral lesions suspected of Lichen Planus; with clinical and histological diagnosis of atrophic or erosive oral Lichen Planus and Exclusion criteria are presence of dysplasia on histological examination; pregnancy; nursing; dysfunction of immune system; hematologic diseases; systemic diseases; history of systemic or topical corticosteroid therapy for Lichen Planus in the past month; Lichenoid reactions due to drug use or restorative materials.
Triamcinolone Acetonide 0.1% with nanoliposomal carriers in orabase and Triamcinolone Acetonide 0.1% in orabase are using 3 times a day for a month in case and control groups, respectively. Pain intensity by Linear Visual Analogue Scale (0-10) and area of the erythematous-ulcerative lesions by grid (mm2) are recording before, one, two and four weeks after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014080416090N5
Registration date:2014-10-04, 1393/07/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-04, 1393/07/12
Registrant information
Name
Arash Azizi
Name of organization / entity
Islamic Azad university-Dental Branch
Country
Iran (Islamic Republic of)
Phone
+98 21 2258 0925
Email address
a_azizi@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Dental Branch, Islamic Azad University of Tehran
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-10-23, 1393/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the efficacy of Triamcinolone Acetonide 0.1 % in Orabase with it's nanoliposomal carriers formulation on oral Lichen Planus patients
Public title
Comparison the efficacy of Triamcinolone Acetonide 0.1 % in Orabase with it's nanoliposomal carriers formulation on oral Lichen Planus patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: All referral patients to Oral Medicine Department of Dental Branch, Islamic Azad University of Tehran with symptomatic oral lesions suspected of Lichen Planus; with confirmed diagnosis clinically and histologically of atrophic or erosive oral Lichen Planus.
Exclusion Criteria: presence of dysplasia on histological examination; pregnancy; nursing; dysfunction of immune system(organ transplantation, lupus erythematous, ulcerative colitis); hematologic diseases; systemic diseases; history of systemic or topical corticosteroid therapy for Lichen Planus in the past month; Lichenoid reactions due to drug use or restorative materials.
Age
No age limit
Gender
Both
Phase
N/A
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
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Dental Branch, Islamic Azad University of Tehran
Street address
No. 4, 10th Neyestan, Pasdaran St.
City
Tehran
Postal code
Approval date
2010-09-24, 1389/07/02
Ethics committee reference number
پ/214/د
Health conditions studied
1
Description of health condition studied
Lichen Planus
ICD-10 code
L43
ICD-10 code description
Papulosquamous disorders
Primary outcomes
1
Description
pain intensity
Timepoint
before treatment, 1, 2 and 4 weeks after treatment
Method of measurement
Visual Analogue Scale
2
Description
area of the erythematous-erosive lesion
Timepoint
before treatment, 1, 2 and 4 weeks after treatment
Method of measurement
mm2
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Triamcinolone Acetonide 0.1% with nanoliposomal carriers in Orabase, Oral paste, three times a day for a month
Category
Treatment - Drugs
2
Description
Control group: Triamcinolone Acetonide 0.1% in Orabase, Oral paste, three times a day for a month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Branch Islamic Azad University of Tehran
Full name of responsible person
Dr. Arash Azizi
Street address
No. 4, 10th Neyestan, Pasdaran St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dental Branch Islamic Azad University of Tehran
Full name of responsible person
Dr Rima Hossein Zade Nik
Street address
No. 4, 10th Neyestan, Pasdaran St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental Branch Islamic Azad University of Tehran
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 Branch Islamic Azad University of Tehran
Full name of responsible person
Dr. Arash Azizi
Position
Oral Medicine Specialist
Other areas of specialty/work
Street address
Oral Medicine Department, No. 4, 10th Neyestan, Pasdaran St.
City
Tehran
Postal code
19585175
Phone
+98 21 2258 0925
Fax
Email
a_azizi@dentaliau.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental Branch Islamic Azad University of Tehran
Full name of responsible person
Dr. Arash Azizi
Position
Associate
Other areas of specialty/work
Street address
No. 4, 10th Neyestan, Pasdaran St.
City
Tehran
Postal code
Phone
+98 21 2258 0925
Fax
Email
a_azizi@dentaliau.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental Branch Islamic Azad University of Tehran
Full name of responsible person
Dr. Arash Azizi
Position
Associate
Other areas of specialty/work
Street address
No. 4, 10th Neyestan, Pasdaran St.
City
Tehran
Postal code
19585175
Phone
+98 21 2258 0925
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)