An observational study in Oral Leukoplakia, Oral Lichen Planus and Premalignant Lesion, sponsored by The Oxford Dental College, Hospital and Research Center, Bangalore, India. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-05.
Sponsored by The Oxford Dental College, Hospital and Research Center, Bangalore, India · Observational
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.
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.
48 studies on the registry are indexed under Leukoplakia, Oral; 11 are open to participants now.
This study's enrollment of 27 is below the median of 97 across 20 observational studies indexed under Leukoplakia, Oral.
Browse Leukoplakia, Oral studies →The Oxford Dental College, Hospital and Research Center, Bangalore, India is the lead sponsor of 4 studies on the registry; none are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Lesions that were stained positive with rose bengal were biopsied and assessed for dysplasia
Procedure: Biopsy · Diagnostic Test: Rose Bengal
Lesions that were stained positive with toluidine blue were biopsied and assessed for dysplasia
Procedure: Biopsy · Diagnostic Test: toluidine blue
rose bengal stain and toluidine is applied over a premalignant lesion and positively stained lesions are subjected to biopsy.
the lesions stained positive were subjected to biopsy
the lesions stained positive were subjected to biopsy
Number and Percentage of Lesions That Were Stained Positive
outcome measure1
Time frame: 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
Time frame: 2 weeks
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 )
Time frame: 2 weeks
patients were recruited from the outpatient department of the dental college where the study was conducted.
| Milestone | All Study Participants |
|---|---|
| Started | 27 |
| Completed | 25 |
| Not completed | 2 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Lesion disappeared after stopping habit | 1 |
outcome measure1
| lesions | Rose Bengal Staining | Toluidine Blue Staining |
|---|---|---|
| Number and Percentage of Lesions That Were Stained Positive | 29 | 28 |
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
| percentage of lesions | All Study Participants |
|---|---|
| sensitivity | 100 |
| specificity | 90 |
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 )
| lesions | Rose Bengal Staining and Biopsy |
|---|---|
| dysplasia present | 5 |
| dysplasia absent | 15 |
| squamous cell carcinoma | 1 |
Collected over 14th day from the date of recruitment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rose Bengal Positive Lesion | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Toluidine Blue Positive Lesions and Biopsy | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
all the patients who had premalignant lesions and had stopped using tobacco in the past two weeks
| Age, Categorical(lesions) | All Study Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 38 |
| >=65 years | 0 |
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 38.16 ± 9.6 |
| Sex: Female, Male(lesions) | All Study Participants |
|---|---|
| Female | 6 |
| Male | 32 |
| tobacco habit(lesions) | All Study Participants |
|---|---|
| Count of units | 36 |
| location of the lesion(lesions) | All Study Participants |
|---|---|
| buccal mucosa | 31 |
| labial mucosa | 5 |
| tongue | 1 |
| gingiva | 1 |
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Mar 2015, a primary completion of Mar 2016 and a completion of Mar 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2018, 2 years 8 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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The Oxford Dental College, Hospital and Research Center, Bangalore, India