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

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ClinicalTrials.gov Identifier: NCT03031899
Recruitment Status : Completed
First Posted : January 26, 2017
Results First Posted : November 5, 2018
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Anisha Ramachandra Yaji, The Oxford Dental College, Hospital and Research Center, Bangalore, India

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.


Condition or disease Intervention/treatment
Oral Leukoplakia Oral Lichen Planus Premalignant Lesion Procedure: Biopsy Diagnostic Test: Rose Bengal Diagnostic Test: toluidine blue

Detailed Description:

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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 27 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Efficacy of Rose Bengal in Comparison With Toluidine Blue in Detection of Premalignant Lesions: a Preliminary Study
Study Start Date : March 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Group/Cohort Intervention/treatment
Rose Bengal positive lesion and biopsy
Lesions that were stained positive with rose bengal were biopsied and assessed for dysplasia
Procedure: Biopsy
rose bengal stain and toluidine is applied over a premalignant lesion and positively stained lesions are subjected to biopsy.

Diagnostic Test: Rose Bengal
the lesions stained positive were subjected to biopsy

Toluidine blue positive lesion and biopsy
Lesions that were stained positive with toluidine blue were biopsied and assessed for dysplasia
Procedure: Biopsy
rose bengal stain and toluidine is applied over a premalignant lesion and positively stained lesions are subjected to biopsy.

Diagnostic Test: toluidine blue
the lesions stained positive were subjected to biopsy




Primary Outcome Measures :
  1. Number and Percentage of Lesions That Were Stained Positive [ Time Frame: 2 weeks ]
    outcome measure1

  2. Sensitivity and Specificity (Percentage of True Positives and True Negatives) [ Time Frame: 2 weeks ]
    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


Secondary Outcome Measures :
  1. Presence of Dysplasia in Biopsied Lesions That Were Stained by Rose Bengal [ Time Frame: 2 weeks ]
    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 )


Biospecimen Retention:   Samples With DNA
Biopsy specimen of the lesion was retained.


Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The 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.
Criteria

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

Layout table for additonal information
Responsible Party: Anisha Ramachandra Yaji, doctor, The Oxford Dental College, Hospital and Research Center, Bangalore, India
ClinicalTrials.gov Identifier: NCT03031899     History of Changes
Other Study ID Numbers: 219/2014-15
First Posted: January 26, 2017    Key Record Dates
Results First Posted: November 5, 2018
Last Update Posted: November 5, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Precancerous Conditions
Leukoplakia
Leukoplakia, Oral
Lichen Planus, Oral
Lichen Planus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases
Neoplasms
Pathological Conditions, Anatomical
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Tolonium Chloride
Hemostatics
Coagulants
Heparin Antagonists
Molecular Mechanisms of Pharmacological Action