Aims: Comparison of the treatment efficacy between hyaluronic acid/triamcinolone and triamcinolone alone administered intralesionally in terms of cure and recurrence rate of oral lichen planus lesions. Participants: Study population is from those patients referred to Oral and Maxillofacial Medicine Department, Faculty of Dentistry, Tehran University of Medical Sciences. Sample size is 28 people based on statistical formulation. Type of intervention: 7mg sterilized hyaluronic acid powder is dissolved in one triamcinolone acetonide vial (40 mg/ml). Both preparation of hyaluronic acid/triamcinolone and triamcinolone are injected by 1 cc syringes into the oral lichen planus lesions which were divided into case and control groups randomly. Lesions were anesthetized by lidocaine 2% and epinephrine solutions. Cure and recurrence are followed after 14 and 28 days, and also after two, three, four, five, and six months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201612241559N11
Registration date:2017-01-16, 1395/10/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-16, 1395/10/27
Registrant information
Name
Farzaneh Aghahoseini
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6611 2437
Email address
aghahose@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Private funding sources
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intralesional injection of Hyaluronic Acid and Triamcinolone in Oral Lichen Planus
Public title
The effect of Hyaluronic Acid and Triamcinolone in Oral Lichen Planus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Bilateral presence of white reticular-papular lesions; histopathological criteria such as hydropic (liquefactive) degeneration of basal layer; band-like infiltration of mononuclear inflammatory cells in the superficial connective tissue; erosive/ulcerative form of lesion and atrophic/erythematous form of lesion.
Exclusion criteria: Dysplasia; systemic diseases; history of chemotherapy; history of radiotherapy; pregnancy and nursing; history of allergy to hyaluronic acid
Age
From 35 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Commitee of Tehran University of Medical Sciences
Street address
Vice chancellor for research of Tehran University of Medical Sciences, Qhods street, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2016-10-13, 1395/07/22
Ethics committee reference number
IR.TUMS.VCR.REC.1395.722
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
cure
Timepoint
14 days and 28 days after intervention and then monthly up to 6 month
Method of measurement
clinical examination
2
Description
recurrence
Timepoint
14 days and 28 days after intervention and then monthly up to 6 month
Method of measurement
clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: 7mg hyaluronic acid powder dissolved in one triamcinolone vial, via intralesionally injection, one time at the beginning of the treatment
Category
Treatment - Drugs
2
Description
control: triamcinolone, via intralesionally injection, one time at the beginning of the treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental faculty of Tehran University of Medical Sciences
Full name of responsible person
khatereh Akbari
Street address
Department of Oral and Maxillofacial Medicine, Ground floor, Dental faculty of Tehran University of medical sciences, North Karegar street, beside Nuclear Energy Organization
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Private funding source
Full name of responsible person
Farzaneh Aghahoseini
Street address
Department of Oral and Maxillofacial Medicine, Ground floor, Dental faculty of Tehran University of medical sciences, North Karegar street, beside Nuclear Energy Organization
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Private funding source
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 of Tehran Univercity of Medical Sciences
Full name of responsible person
Khatereh Akbari
Position
Resident of Oral and Maxillofacial Medicine
Other areas of specialty/work
Street address
Department of Oral and Maxillofacial Medicine, Ground floor, Dental faculty of Tehran University of medical sciences, North Karegar street, beside Nuclear Energy Organization
City
Tehran
Postal code
1439955991
Phone
+98 21 4423 3115
Fax
Email
kh_akbari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental faculty of Tehran University of Medical Sciences
Full name of responsible person
Farzaneh Aghahoseini
Position
Professor of Department of Oral and Maxillofacial Medicine, Faculty of Dentistry, Tehran University
Other areas of specialty/work
Street address
Department of Oral and Maxillofacial Medicine, Ground floor, Dental faculty of Tehran University of medical sciences, North Karegar street, beside Nuclear Energy Organization
City
Tehran
Postal code
1439955991
Phone
+98 21 4279 4151
Fax
Email
aghahose@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental faculty of Tehran University of Medical Sciences
Full name of responsible person
Mahdieh Sadat Moosavi
Position
Oral & Maxillofacial Medicine Board
Other areas of specialty/work
Street address
Department of Oral and Maxillofacial Medicine, Ground floor, Dental faculty of Tehran University of medical sciences, North Karegar street, beside Nuclear Energy Organization
City
Tehran
Postal code
1439955991
Phone
00
Fax
Email
ms-moosavi@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)