N/A N=27

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

Oral Leukoplakia · Oral Lichen Planus · Premalignant Lesion

Bottom Line

View on ClinicalTrials.gov: NCT03031899 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2018

Primary outcome: Primary: Number and Percentage of Lesions That Were Stained Positive — 29; 28 lesions — p=0.005

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Biopsy (Procedure); Rose Bengal (Diagnostic_test); toluidine blue (Diagnostic_test)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The Oxford Dental College, Hospital and Research Center, Bangalore, India
Primary completion: Mar 2016

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	—

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.

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

View full record on ClinicalTrials.gov →

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.