N/A
Completed N=27
Comparison or Rose Bengal and Toluidine Blue Staining for Lesion Detection Efficacy
oral leukoplakia · Oral Lichen Planus · Premalignant Lesion
Source: ClinicalTrials.gov NCT03031899 ↗
Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcomePrimary: Number and Percentage of Lesions That Were Stained Positive — 29; 28 lesions — p=0.005
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Percentage of Lesions That Were Stained Positive |
29; 28 | 0.005 sig |
| PRIMARY Sensitivity and Specificity (Percentage of True Positives and True Negatives) |
100; 90 | — |
| SECONDARY Presence of Dysplasia in Biopsied Lesions That Were Stained by Rose Bengal |
5; 15; 1 | — |
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
Data sourced from ClinicalTrials.gov (NCT03031899). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.