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
Phase 1
Completed
- Conditions
- a novel adjunctive approach for identifying dysplastic alterations in oral epithelial tissue.Oral cancer
- Registration Number
- TCTR20240429002
- Lead Sponsor
- Royal College of Dental Surgeons of Thailand
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 36
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity 3 months after intervention Compare with pathologic evaluation,Specificity 3 months after intervention Compare with pathologic evaluation
- Secondary Outcome Measures
Name Time Method 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