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Innovative Screening Approach: The Sensitivity and Specificity of Electrospun Containing Toluidine Blue Optimized Using Design of Experiment in the Detection of Oral Potentially Malignant Disorders

Innovative Screening Approach: The Sensitivity and Specificity of Electrospun Containing Toluidine Blue Optimized Using Design of Experiment in the Detection of Oral Potentially Malignant Disorders

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240429002
Enrollment
30
Registered
2024-04-29
Start date
2021-03-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

a novel adjunctive approach for identifying dysplastic alterations in oral epithelial tissue. Oral cancer

Interventions

Apply electrospun containing toluidine blue for detection of oral potentially malignant disorders compare with biopsy for histopathologic evaluation
Experimental Device
Electrospun containing Toluidine Blue

Sponsors

Royal College of Dental Surgeons of Thailand
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Male or female, age > 20 years old 2. Patients who are suspected of having oral potentially malignant disorders 3. Patients with non-healing ulcer > 2 weeks 4. Patients who can be followed up 5. Patients who give their consent for the study

Exclusion criteria

Exclusion criteria: 1. Patients with severe systemic diseases 2. Patients having obvious invasive carcinomas 3. Patients who abandoned treatment 4. Patients who refuse to join the study 5. Patients who are allergic to toluidine blue, acetic acid, polyvinylpyrrolidone or local anesthetic agents 6. Patients who deny tissue biopsy with toluidine blue

Design outcomes

Primary

MeasureTime frame
Sensitivity 3 months after intervention Compare with pathologic evaluation,Specificity 3 months after intervention Compare with pathologic evaluation

Secondary

MeasureTime frame
Sex after end of the intervention using a questionnaire interview,Age after end of the intervention using a questionnaire interview,Location of lesion after end of the intervention using clinical evaluation,Habit after end of the intervention using a questionnaire interview

Countries

Thailand

Contacts

Public ContactSupanat Supakornpichan

Faculty of Dentistry, Chiang Mai University

veeomfs@gmail.com0875540440

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026