Oral Lichen Planus Clinical Trial
Official title:
Efficacy of Rose Bengal in Comparison With Toluidine Blue in Detection of Premalignant Lesions: a Preliminary Study
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.
Introduction Toluidine blue staining is the most common technique used for the early
detection of dysplastic changes in patients with premalignant lesions. One meta-analysis of
Rosenberg et al. previously published reported sensitivity ranged from 93.5% to 97.8% and the
specificity ranged from 73.3% to 92.9%. Zang et al reported that TB not only detects
high-grade dysplasia but detects OPLs with minimal or no dysplasia with high-risk clinical
and molecular attributes.4 But, studies have shown as high as 30% risk of false-positive
staining.
Rose Bengal (RB) has been widely used to diagnose various ocular surface disorders including
delineation of the extent of corneal and conjunctival neoplasms. It has been believed to
stain desquamated ocular epithelial cells, dead or degenerated cells, or wherever there is
poor protection of the surface epithelium by the preocular tear film rather than lack of cell
vitality. These characteristic features of RB lead the researchers to apply it in oral
premalignant lesions.5 In none of the studies, reliability of RB stains was not compared with
existing or previously practiced methods in oral premalignant lesions. Hence this study was
undertaken with the aim of comparing the RB and TB stain and for early detection of dysplasia
in oral premalignant lesions.
Materials and Methods:
Study group consists of 41 oral premalignant lesions in patients visiting the Department of
Oral Medicine and Radiology of The oxford dental college and hospital, Bangalore. Patients
with OSMF, patients with bleeding disorders, patient with other systemic diseases were
excluded from the study.To perform the present study, ethical clearance was obtained from the
Institutional Ethical Board. Study procedure was explained and informed consent was taken
from the selected patients with premalignant lesions. The patients with lesions were
subjected to detailed case history, intra oral examination and photographs of the lesions
were recorded. Patients with habits were counselled to quit the habit and recalled after 2
weeks for staining. Since one patient had not quit the habit in the two weeks from first
visit, in another patient the lesion disappeared in two weeks 2 patients (3 lesions) were not
included in the study. (Graph1)
Initially patients were asked to rinse their mouth with distilled water for 1 minute. 1% RB
solution was applied with a cotton tip for 2 minutes. Again patients were asked to rinse
their mouth for 1 minute with distilled water to remove excess RB solution and the area which
had taken up the stain was photographed. Following this, patients were asked to rinse their
mouth with 1% acetic acid for 1 min to remove the remaining RB stain from the lesion and were
prepared for TB staining. 1%Toluidineblue is applied over the lesion and after 30 seconds
patients were made to swish with 1% acetic acid and the area stained was recorded
photographically.
These two photographs were assessed and if the stained area was similar in both the
procedures single biopsy was taken. If the stained areas were different two different
biopsies were taken.
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