Trial Outcomes & Findings for Comparison or Rose Bengal and Toluidine Blue Staining for Lesion Detection Efficacy (NCT NCT03031899)
NCT ID: NCT03031899
Last Updated: 2018-11-05
Results Overview
outcome measure1
Recruitment status
COMPLETED
Target enrollment
27 participants
Primary outcome timeframe
2 weeks
Results posted on
2018-11-05
Participant Flow
patients were recruited from the outpatient department of the dental college where the study was conducted.
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
Unit of analysis: lesions
Participant milestones
| Measure |
All Study Participants
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.
|
|---|---|
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Overall Study
STARTED
|
27 41
|
|
Overall Study
COMPLETED
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25 38
|
|
Overall Study
NOT COMPLETED
|
2 3
|
Reasons for withdrawal
| Measure |
All Study Participants
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.
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|---|---|
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Overall Study
Protocol Violation
|
1
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Overall Study
lesion disappeared after stopping habit
|
1
|
Baseline Characteristics
Comparison or Rose Bengal and Toluidine Blue Staining for Lesion Detection Efficacy
Baseline characteristics by cohort
| Measure |
All Study Participants
n=38 lesions
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.
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|---|---|
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location of the lesion
tongue
|
1 lesions
n=20 lesions
|
|
location of the lesion
gingiva
|
1 lesions
n=20 lesions
|
|
Age, Categorical
<=18 years
|
0 lesions
n=20 lesions
|
|
Age, Categorical
Between 18 and 65 years
|
38 lesions
n=20 lesions
|
|
Age, Categorical
>=65 years
|
0 lesions
n=20 lesions
|
|
Age, Continuous
|
38.16 years
STANDARD_DEVIATION 9.6 • n=39 Participants
|
|
Sex: Female, Male
Female
|
6 lesions
n=20 lesions
|
|
Sex: Female, Male
Male
|
32 lesions
n=20 lesions
|
|
tobacco habit
|
36 lesions
n=20 lesions
|
|
location of the lesion
buccal mucosa
|
31 lesions
n=20 lesions
|
|
location of the lesion
labial mucosa
|
5 lesions
n=20 lesions
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: patients diagnosed with premalignant lesions who consented to participate in the study
outcome measure1
Outcome measures
| Measure |
Rose Bengal Staining
n=38 lesions
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.
|
Toluidine Blue Staining
n=38 lesions
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.
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|---|---|---|
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Number and Percentage of Lesions That Were Stained Positive
|
29 lesions
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28 lesions
|
PRIMARY outcome
Timeframe: 2 weekssensitivity: 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
Outcome measures
| Measure |
Rose Bengal Staining
n=38 lesions
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.
|
Toluidine Blue Staining
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.
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|---|---|---|
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Sensitivity and Specificity (Percentage of True Positives and True Negatives)
sensitivity
|
100 percentage of lesions
|
—
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Sensitivity and Specificity (Percentage of True Positives and True Negatives)
specificity
|
90 percentage of lesions
|
—
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SECONDARY outcome
Timeframe: 2 weeksthis 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 )
Outcome measures
| Measure |
Rose Bengal Staining
n=21 lesions
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.
|
Toluidine Blue Staining
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.
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|---|---|---|
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Presence of Dysplasia in Biopsied Lesions That Were Stained by Rose Bengal
dysplasia present
|
5 lesions
|
—
|
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Presence of Dysplasia in Biopsied Lesions That Were Stained by Rose Bengal
dysplasia absent
|
15 lesions
|
—
|
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Presence of Dysplasia in Biopsied Lesions That Were Stained by Rose Bengal
squamous cell carcinoma
|
1 lesions
|
—
|
Adverse Events
Rose Bengal Positive Lesion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Toluidine Blue Positive Lesions and Biopsy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place