Oral Lichen Planus Clinical Trial
Official title:
Efficacy of Rose Bengal in Comparison With Toluidine Blue in Detection of Premalignant Lesions: a Preliminary Study
NCT number | NCT03031899 |
Other study ID # | 219/2014-15 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 2015 |
Est. completion date | March 2016 |
Verified date | March 2018 |
Source | The Oxford Dental College, Hospital and Research Center, Bangalore, India |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Abstract
Objective:
To study the diagnostic efficiency of Rose Bengal with Toluidine blue in detecting the biopsy
sites and thus establish an accurate diagnosis in oral premalignant lesions.
Materials and method:
In our study 27 patients with 41 lesions were included. Since one patient had not quit the
habit in the two weeks following initial examination and another lesion disappeared in the
waiting period, 2 patients (3 lesions) were not included in the study. Out of 38 lesions
diagnosed based on clinical criteria, 32 were leukoplakia, 5 lichen planus and 1 SCC. After
initial examination they were subjected to Rose Bengal and Toluidine blue stain. If stained
positive they were subjected to biopsy.
Status | Completed |
Enrollment | 27 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with clinically diagnosed oral premalignant lesions (oral leukoplakia and oral lichen planus). Exclusion Criteria: - Patients with OSMF - bleeding disorders and - other systemic diseases |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
The Oxford Dental College, Hospital and Research Center, Bangalore, India |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number and Percentage of Lesions That Were Stained Positive | outcome measure1 | 2 weeks | |
Primary | Sensitivity and Specificity (Percentage of True Positives and True Negatives) | sensitivity: Percentage of lesions stained positive with Toluidine blue stain that were also stained positive with Rose Bengal stain specificity: Percentage of lesions stained negative with Toluidine blue stain that were also stained negative with Rose Bengal stain | 2 weeks | |
Secondary | Presence of Dysplasia in Biopsied Lesions That Were Stained by Rose Bengal | this outcome measure was limited to the biopsied lesions.additionally, the intent of this outcome measure was only to study early detection of dysplasia in oral premalignant lesions using the Rose bengal stain. (no comparison between the two stains were intended ) | 2 weeks |
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