Visual oral exam, followed by OraTest Rinse Staining Procedure

OraTest + Visual Exam

Sex: Female, Male

Region of Enrollment

Primary efficacy parameters, ratio of sensitivity of OraTest® in combination with visual exam versus visual exam alone is the difference between the adjusted specificity for OraTest in combination with visual exam and the adjusted specificity for visual exam alone.
Reported ratio as percentage of patients with abnormalities (suspicious lesions) found upon visual exam of the mouth with and without OraTest® dye.

Ratio (Percentage) of Sensitivity of OraTest + Visual Exam Versus Sensitivity of Visual Exam Alone

Overall Study

Mark Chambers, MS, DMD / Professor

Head And Neck Cancer

Oropharynx Cancer

Two (2) scheduled visits for visual examination of mouth for abnormal lesions and glands in the neck.

Visual Examination

Two (2) scheduled visits for rinse staining: 2 teaspoons of OraTest for 20 seconds, then spit.

OraTest

U.T.M.D. Anderson Cancer Center

OraTest in Combination With Visual Examination and Visual Examination Alone

Evaluation of OraTest in Combination With Visual Examination in the Improved Detection of Oral Mucosal Lesions Suspicious of Serious Pathology in High-Risk Patients for the Purpose of Referral to the Health Care Professional Experienced in Oral Cancer: Phase III Clinical Trial Comparing the Sensitivity and Assessing the Specificity of OraTest in Combination With Visual Examination and Visual Examination Alone in Patients at High Risk as Defined by Age and Lifestyle Factors (ZIL-401)

ribes sanguineum/dental caries

OraTest in Combination With Visual Examination and Visual Examination Alone

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