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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

Tracking Information
First Submitted Date December 14, 2016
First Posted Date January 26, 2017
Results First Submitted Date February 2, 2017
Results First Posted Date November 5, 2018
Last Update Posted Date November 5, 2018
Study Start Date March 2015
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 6, 2018)
  • Number and Percentage of Lesions That Were Stained Positive [ Time Frame: 2 weeks ]
    outcome measure1
  • 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
Original Primary Outcome Measures
 (submitted: January 25, 2017)
Positive staining of toluidine blue positive lesions by rose bengal [ Time Frame: 2 weeks after stopping the habit ]
Ability of rose Bengal to stain premalignant lesions comparison with Toluidine blue stain
Change History Complete list of historical versions of study NCT03031899 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 6, 2018)
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 )
Original Secondary Outcome Measures
 (submitted: January 25, 2017)
Presence of dysplasia in biopsied lesions that were stained by rose bengaal [ Time Frame: 2 weeks after stopping the habit ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparison or Rose Bengal and Toluidine Blue Staining for Lesion Detection Efficacy
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 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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Biopsy specimen of the lesion was retained.
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.
Condition
  • Oral Leukoplakia
  • Oral Lichen Planus
  • Premalignant Lesion
Intervention
  • 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
  • Diagnostic Test: toluidine blue
    the lesions stained positive were subjected to biopsy
Study Groups/Cohorts
  • Rose Bengal positive lesion and biopsy
    Lesions that were stained positive with rose bengal were biopsied and assessed for dysplasia
    Interventions:
    • Procedure: Biopsy
    • Diagnostic Test: Rose Bengal
  • Toluidine blue positive lesion and biopsy
    Lesions that were stained positive with toluidine blue were biopsied and assessed for dysplasia
    Interventions:
    • Procedure: Biopsy
    • Diagnostic Test: toluidine blue
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 6, 2018)
27
Original Actual Enrollment
 (submitted: January 25, 2017)
41
Actual Study Completion Date March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03031899
Other Study ID Numbers 219/2014-15
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Anisha Ramachandra Yaji, The Oxford Dental College, Hospital and Research Center, Bangalore, India
Study Sponsor The Oxford Dental College, Hospital and Research Center, Bangalore, India
Collaborators Not Provided
Investigators Not Provided
PRS Account The Oxford Dental College, Hospital and Research Center, Bangalore, India
Verification Date March 2018