AzTrials
AzTrials

Oral LeukoplakiaNCT03031899

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

An observational study of Oral Leukoplakia and Oral Lichen Planus, run by The Oxford Dental College, Hospital and Research Center, Bangalore, India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biopsy, Rose Bengal and toluidine blue
Type of treatment
Surgery or procedure
How many people
27 participants
Where
No sites listed yet
Study dates
Mar 2015to Mar 2016
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • Patients with clinically diagnosed oral premalignant lesions (oral leukoplakia and oral lichen planus).

Who cannot join

  • Patients with OSMF
  • bleeding disorders and
  • other systemic diseases

About this study

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

Abstract

Objective:

Read more

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.

Read the 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.

Being tested
Biopsy, Rose Bengal, toluidine blue
Medical subject headings
Leukoplakia, Oral, Lichen Planus, Oral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BiopsyProcedure or surgery

    rose bengal stain and toluidine is applied over a premalignant lesion and positively stained lesions are subjected to biopsy.

  • Rose BengalDiagnostic test

    the lesions stained positive were subjected to biopsy

  • toluidine blueDiagnostic test

    the lesions stained positive were subjected to biopsy

Study groups in NCT03031899
Study groupRoleWhat they receive
Rose Bengal positive lesion and biopsyLesions that were stained positive with rose bengal were biopsied and assessed for dysplasia
Receives: Procedure: Biopsy; Diagnostic Test: Rose Bengal
Toluidine blue positive lesion and biopsyLesions that were stained positive with toluidine blue were biopsied and assessed for dysplasia
Receives: Procedure: Biopsy; Diagnostic Test: toluidine blue

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number and Percentage of Lesions That Were Stained Positive

    outcome measure1

    Measured: 2 weeks

  2. 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

    Measured: 2 weeks

Secondary outcomes (1)
  1. 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 )

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2017 (estimated)
  2. Study startMar 2015
  3. Primary completionMar 2016
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03031899
Sponsor's protocol ID
219/2014-15
Status last verified
Mar 2018
First submitted
14 Dec 2016
Last updated
5 Nov 2018
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Oral Leukoplakia and Oral Lichen Planus, run by The Oxford Dental College, Hospital and Research Center, Bangalore, India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number and Percentage of Lesions That Were Stained Positive (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2018.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in