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

NCT03031899 | Completed Results DMC

• 1 other identifier: 219/2014-15
• Study Type: observational
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Oral Leukoplakia; Oral Lichen Planus; Premalignant Lesion

Outcome Measures

Primary Outcomes (2)

• Number and Percentage of Lesions That Were Stained Positive

  outcome measure1

  2 weeks

• Sensitivity and Specificity (Percentage of True Positives and True Negatives)

  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

  2 weeks

Secondary Outcomes (1)

• Presence of Dysplasia in Biopsied Lesions That Were Stained by Rose Bengal

  2 weeks

Study Arms (2)

Rose Bengal positive lesion and biopsy

Lesions that were stained positive with rose bengal were biopsied and assessed for dysplasia

Procedure: Biopsy; Diagnostic Test: Rose Bengal

Toluidine blue positive lesion and biopsy

Lesions that were stained positive with toluidine blue were biopsied and assessed for dysplasia

Procedure: Biopsy; Diagnostic Test: toluidine blue

Interventions

Biopsy PROCEDURE

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

Rose Bengal positive lesion and biopsy; Toluidine blue positive lesion and biopsy

Rose Bengal DIAGNOSTIC_TEST

the lesions stained positive were subjected to biopsy

Rose Bengal positive lesion and biopsy

toluidine blue DIAGNOSTIC_TEST

the lesions stained positive were subjected to biopsy

Toluidine blue positive lesion and biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study group consists of 41 oral premalignant lesions in patients visiting the Department of Oral Medicine and Radiology of The Oxford Dental College and Hospital, Bangalore.

You may qualify if:

• Patients with clinically diagnosed oral premalignant lesions (oral leukoplakia and oral lichen planus).

You may not qualify if:

• Patients with OSMF
• bleeding disorders and
• other systemic diseases

Sponsors & Collaborators

• The Oxford Dental College, Hospital and Research Center, Bangalore, India: lead

Biospecimen

Retention: SAMPLES WITH DNA

Biopsy specimen of the lesion was retained.

MeSH Terms

Conditions

Leukoplakia, Oral; Lichen Planus, Oral

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Leukoplakia; Precancerous Conditions; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Limitations and Caveats

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

Results Point of Contact

• Title: Dr. Anisha Yaji
• Organization: The Oxford Dental college

dr.anishayaji@gmail.com

9480718531

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: January 26, 2017
• Study Start: March 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: November 5, 2018
• Results First Posted: November 5, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share