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

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ClinicalTrials.gov Identifier: NCT03031899
Recruitment Status : Completed
First Posted : January 26, 2017
Results First Posted : November 5, 2018
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Anisha Ramachandra Yaji, The Oxford Dental College, Hospital and Research Center, Bangalore, India

Study Type Observational
Study Design Observational Model: Case-Control;   Time Perspective: Cross-Sectional
Conditions Oral Leukoplakia
Oral Lichen Planus
Premalignant Lesion
Interventions Procedure: Biopsy
Diagnostic Test: Rose Bengal
Diagnostic Test: toluidine blue
Enrollment 27
Recruitment Details patients were recruited from the outpatient department of the dental college where the study was conducted.
Pre-assignment Details 3 patients were excluded as one patient had not quit the habit and in another patient the lesion regressed during 2 weeks waiting period post habit cessation
Arm/Group Title All Study Participants
Hide Arm/Group Description All patients received Rose Bengal and Toluidine Blue. 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% Toluidine blue was applied over the same lesion and after 30 seconds patients were made to swish with 1% acetic acid and the area stained was photographed.
Period Title: Overall Study
Number of participants Number of units (lesions)
Started 27 41
Completed [1] 25 38
Not Completed 2 3
Reason Not Completed
Protocol Violation             1            
lesion disappeared after stopping habit             1            
[1]
one patient had not quit the habit, another lesion disappeared 2 patients (3 lesions) were excluded
Arm/Group Title All Study Participants
Hide Arm/Group Description All study participants received Rose Bengal and Toulidine Blue. 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% Toluidine blue was applied over the same lesion and after 30 seconds patients were made to swish with 1% acetic acid and the area stained was photographed.
Overall Number of Baseline Participants 25
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
38
Hide Baseline Analysis Population Description
all the patients who had premalignant lesions and had stopped using tobacco in the past two weeks
Age, Categorical   [1] 
Count of Units
Unit of measure:  Lesions
Number Analyzed 38 lesions
<=18 years
0
   0.0%
Between 18 and 65 years
38
 100.0%
>=65 years
0
   0.0%
[1]
Measure Description: a proforma was used to record the baseline details
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants
38.16  (9.6)
Sex: Female, Male  
Count of Units
Unit of measure:  Lesions
Number Analyzed 38 lesions
Female
6
  15.8%
Male
32
  84.2%
tobacco habit   [1] 
Count of Units
Unit of measure:  Lesions
Number Analyzed 38 lesions
36
  94.7%
[1]
Measure Description: patients were asked regarding the usage of tobacco products and was recorded in proforma by investigator
location of the lesion  
Count of Units
Unit of measure:  Lesions
Number Analyzed 38 lesions
buccal mucosa
31
  81.6%
labial mucosa
5
  13.2%
tongue
1
   2.6%
gingiva
1
   2.6%
1.Primary Outcome
Title Number and Percentage of Lesions That Were Stained Positive
Hide Description outcome measure1
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
patients diagnosed with premalignant lesions who consented to participate in the study
Arm/Group Title Rose Bengal Staining Toluidine Blue Staining
Hide Arm/Group Description:
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. positively stained lesions were subjected for biopsy.
Following RB staining, 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% Toluidine blue was applied over the same lesion and after 30 seconds patients were made to swish with 1% acetic acid and the area stained was photographed. positively stained lesions were subjected to biopsy.
Overall Number of Participants Analyzed 25 25
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
38 38
Count of Units
Unit of Measure: lesions
29
  76.3%
28
  73.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rose Bengal Staining, Toluidine Blue Staining
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments
  1. Rose bengal should stain the areas positively stained by Toluidine blue
  2. areas stained by rose bengal that shows dysplasia in biopsy
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Primary Outcome
Title Sensitivity and Specificity (Percentage of True Positives and True Negatives)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Study Participants
Hide Arm/Group Description:

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.8 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.

1% toluidine blue applied over the lesion and after 30 seconds were made to swish with 1% acetic acid. the area retaining the stain was photographed and compared with that of rose bengal. only positively stained areas were subjected to biopsy procedure.

Overall Number of Participants Analyzed 25
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
38
Measure Type: Number
Unit of Measure: percentage of lesions
sensitivity 100
specificity 90
3.Secondary Outcome
Title Presence of Dysplasia in Biopsied Lesions That Were Stained by Rose Bengal
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rose Bengal Staining and Biopsy
Hide Arm/Group Description:
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. Positively stained lesions were biopsied.
Overall Number of Participants Analyzed 25
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
21
Count of Units
Unit of Measure: lesions
dysplasia present
5
  23.8%
dysplasia absent
15
  71.4%
squamous cell carcinoma
1
   4.8%
Time Frame 14th day from the date of recruitment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rose Bengal Positive Lesion Toluidine Blue Positive Lesions and Biopsy
Hide Arm/Group Description lesions were subjected to rose bengal staining and positive lesions were subjected to biopsy lesions were subjected to toluidine blue staining and positive lesions were subjected to biopsy
All-Cause Mortality
Rose Bengal Positive Lesion Toluidine Blue Positive Lesions and Biopsy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Rose Bengal Positive Lesion Toluidine Blue Positive Lesions and Biopsy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Rose Bengal Positive Lesion Toluidine Blue Positive Lesions and Biopsy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
  1. small sample size
  2. only lesions stained positive were selected for biopsy procedure hence interpretation of the staining was limited to certain lesions only
  3. a colorimetric guide was not used measure the intensity of staining
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Anisha Yaji
Organization: The Oxford Dental college
Phone: 9480718531
EMail: dr.anishayaji@gmail.com
Layout table for additonal information
Responsible Party: Anisha Ramachandra Yaji, The Oxford Dental College, Hospital and Research Center, Bangalore, India
ClinicalTrials.gov Identifier: NCT03031899     History of Changes
Other Study ID Numbers: 219/2014-15
First Submitted: December 14, 2016
First Posted: January 26, 2017
Results First Submitted: February 2, 2017
Results First Posted: November 5, 2018
Last Update Posted: November 5, 2018