CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 27 enrolled
Drug / intervention
Biopsy +2 moreprocedure
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03031899
NCT03031899N/ACompleted

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

The Oxford Dental College, Hospital and Research Center, Bangalore, India·observational·Posted Jan 26, 2017·Updated Nov 5, 2018

In Brief

An observational study evaluating Biopsy, Rose Bengal, and 1 other intervention for Oral Leukoplakia and 2 related conditions. Completed, enrolled 27 participants.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 26, 2017
Enrollment StartMar 1, 2015
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 9.4 years ago

Interventions

Biopsyprocedure

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

Rose Bengalother

the lesions stained positive were subjected to biopsy

toluidine blueother

the lesions stained positive were subjected to biopsy