Clinical Trial: Comparison or Rose Bengal and Toluidine Blue Staining for Lesion Detection Efficacy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy of Rose Bengal in Comparison With Toluidine Blue in Detection of Premalignant Lesions: a Preliminary Study

Brief Summary:

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.

Detailed Summary:

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 other premalignant conditions (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 inform
Sponsor: The Oxford Dental College, Hospital and Research Center, Bangalore, India

Current Primary Outcome: Positive staining of toluidine blue positive lesions by rose bengal [ Time Frame: 2 weeks after stopping the habit ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Presence of dysplasia in biopsied lesions that were stained by rose bengaal [ Time Frame: 2 weeks after stopping the habit ]

Original Secondary Outcome: Same as current

Information By: The Oxford Dental College, Hospital and Research Center, Bangalore, India

Dates:
Date Received: December 14, 2016
Date Started: March 2015
Date Completion:
Last Updated: January 25, 2017
Last Verified: January 2017