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.
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
- Conditions the study is for
- Oral Leukoplakia, Oral Lichen Planus, Premalignant Lesion
- 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.
- Conditions
- Oral Leukoplakia, Oral Lichen Planus, Premalignant Lesion
- 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 group | Role | What they receive |
|---|---|---|
| Rose Bengal positive lesion and biopsy | Lesions 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 biopsy | Lesions 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.
Number and Percentage of Lesions That Were Stained Positive
outcome measure1
Measured: 2 weeks
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)
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.
- First posted26 Jan 2017 (estimated)
- Study startMar 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Oral LeukoplakiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- The Oxford Dental College, Hospital and Research Center, Bangalore, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anisha Ramachandra Yaji, The Oxford Dental College, Hospital and Research Center, Bangalore, India
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Rose Bengal in Comparison With Toluidine Blue in Detection of Premalignant Lesions: a Preliminary Study
- ClinicalTrials.gov ID
- NCT03031899
- Acronym / sponsor ID
- 219/2014-15
- Conditions
- Oral Leukoplakia, Oral Lichen Planus, Premalignant Lesion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- The Oxford Dental College, Hospital and Research Center, Bangalore, IndiaUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 26 Jan 2017 (estimated)
- Results
- Posted 5 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rose Bengal positive lesion and biopsy | – | Procedure: Biopsy, Diagnostic Test: Rose BengalLesions that were stained positive with rose bengal were biopsied and assessed for dysplasia |
| Toluidine blue positive lesion and biopsy | – | Procedure: Biopsy, Diagnostic Test: toluidine blueLesions that were stained positive with toluidine blue were biopsied and assessed for dysplasia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- Patients with clinically diagnosed oral premalignant lesions (oral leukoplakia and oral lichen planus).
Key exclusion criteria (3 listed)
- Patients with OSMF
- bleeding disorders and
- other systemic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsyrose bengal stain and toluidine is applied over a premalignant lesion and positively stained lesions are subjected to biopsy. | Procedure or surgery | Rose Bengal positive lesion and biopsy, Toluidine blue positive lesion and biopsy |
| Rose Bengalthe lesions stained positive were subjected to biopsy | Diagnostic test | Rose Bengal positive lesion and biopsy |
| toluidine bluethe lesions stained positive were subjected to biopsy | Diagnostic test | Toluidine blue positive lesion and biopsy |
Primary outcome
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
1 secondary outcome
Presence of Dysplasia in Biopsied Lesions That Were Stained by Rose Bengal
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.