Comparision the effect of topical corticosteroid with photodynamic therapy and topical corticosteroid on pain and size of lesions in oral lichen planus patients
In this study, the efficacy of toluidine blue-mediated photodynamic therapy and topical corticosteroid on decreasing pain and size of oral lichen planus (OLP) lesions will be compared. This randomized double blind clinical trial will compare the therapeutic effect of photodynamic therapy and corticosteroid on OLPs ( atrophic/ erosive/ ulcerative forms). Eleven patients with bilateral oral OLP lesions (22 affected sides) will be recruited in this study during 2016-2017 in Oral and Maxillofacial Department affiliated by Shiraz School of Dentistry. The patients with clinical or histopathology diagnosis of bilateral atrophic or erosive OLP with no other inflammatory diseases or malignancies who sign the written consent form will be recruited. These 22 sides will be randomly divided to control and intervention sides. Every 2 sides of each patient’s mouth (oral mucosa) will be randomly allocated to the intervention or control group. Random allocation will be done through block randomization method. Toluidine blue will be applied on the lesion of intervention side. Then after 10 min, the lesions will be irradiated with a 660nm diode laser for 10 min(power: 25mW). But in control side of oral mucous (other side of the mouth), only sham laser will be used. The therapeutic effects of PDT will be obtained by the activation of toluidine blue. These interventions will be applied on days 3, 5 and 7. In week 3, topical corticosteroid (triamcinolone acetonide 0.1% three times a day) will be prescribed for all the patients who will participate in this research. They will be followed up on weeks 3, 5 and 7. In each session the size of oral lesions and level of pain will be assessed by Thongprasom sign scoring and VAS. Finally the scores will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201606208585N2
Registration date:2017-08-02, 1396/05/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-02, 1396/05/11
Registrant information
Name
Fatemeh Lavaee
Name of organization / entity
Shiraz Dental School
Country
Iran (Islamic Republic of)
Phone
+98 71 1631 9309
Email address
lavaeef@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Shiraz University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-08-30, 1396/06/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision the effect of topical corticosteroid with photodynamic therapy and topical corticosteroid on pain and size of lesions in oral lichen planus patients
Public title
The effect of photodynamic therapy on oral lichen planus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Histopathologically and clinically confirmed oral lichen planus
Bilateral atrophic or erosive or ulcerative oral lichen planus
Signing informed consent
Exclusion criteria:
The patients under 18 years old
Positive history of other inflammatory diseases, malignancies or even dysplastic lesions
The patients who have received treatment for oral lichen planus lesions since a previous month
Pregnant women
The patients with history of photo sensitivity
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The oral lichen planus lesions of patients will be divided to intervention side and control side by block randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Science
Street address
Shiraz University of Medical Science, Namazi square, Zand street, Shiraz, Iran
City
Shiraz
Postal code
Approval date
2016-10-09, 1395/07/18
Ethics committee reference number
IR.SUMS.REC.1395.124
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
pain
Timepoint
day1, 3, 5, week 3, 5, 7
Method of measurement
VAS
2
Description
size
Timepoint
day1, 3, 5, week 3, 5, 7
Method of measurement
scaled tongue blade(mm)
3
Description
clinical presentation or inflammation
Timepoint
day1, 3, 5, week 3, 5, 7
Method of measurement
Thongprasom sign scoring
Secondary outcomes
1
Description
toluidine blue hypersensivity
Timepoint
day1, 3, 5
Method of measurement
clinical symptom of hypersensitivity
Intervention groups
1
Description
In intervention side (one side of the patients’ mouth), photodynamic therapy will be applied for erosive/ulcerative lesions on day 1, 3, 5. Topical toluidine will be applied blue with micropipette for intervention side and after 10 min, the lesion will be irradiated with a 660nm diode laser for 10 min(power: 25mW). No corticosteroid therapy will be prescribed during 2 weeks from last PDT session. After two weeks, topical triamcinolone [triamcinolone acetonide 0.1% (Teriadent) manufactured by Raha pharma.co, Isfahan, Iran] should be used topically after each meal three times a day. Patients will be followed up in week 5 and 7.
Category
Treatment - Other
2
Description
In control side (other side of the mouth), topical toluidine blue with micropipette and sham laser irradiation will be on day 1, 3 and 5. After two weeks, topical triamcinolone [triamcinolone acetonide 0.1%(Teriadent) manufactured by Raha pharma.co, Isfahan, Iran] should be used topically after each meal, three times a day. The patients will be followed up on week 5 and 7.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry, Shiraz University of Medical Sciences