Benzocaine Gel Toothache Dose-Response Study

Inclusion Criteria

• Males or females at least 12 years of age.
• Presence of spontaneous toothache pain in only one permanent tooth. Toothache pain is due only to an open tooth cavity and only as a result of dental caries, loss of a restoration or tooth fracture.
• To qualify for the study, the subject must have a rating of at least moderate pain on the Dental Pain Scale (DPS) and a score of at least 50 mm on the Visual Analog Scale. To be included in the moderate pain stratum, the subjects must have a rating of moderate pain in the DPS and to be included in the severe pain stratum the subjects must have a rating of severe pain in the DPS.
• Females who are neither pregnant, as verified by a urine-based pregnancy test, nor breast-feeding.
• Female subjects of childbearing potential and those who are post-menopausal for less than 2 years must be using a medically approved method of contraception (i.e., oral, transdermal or implanted contraceptive devices, intrauterine device, diaphragm, condom, abstinence, or surgical sterility).
• Subjects must be reliable, cooperative and of adequate intelligence to read and understand the rating scales and other study instructions.
• Subjects must be able to read, comprehend, and sign the consent form. Minors will provide assent to study participation if age appropriate. Parent/legal guardian must be able to read, comprehend, and sign the informed consent form.

Exclusion Criteria

• Presence of spontaneous toothache pain in a primary tooth. Presence of spontaneous toothache pain in more than one tooth. Presence of an open tooth cavity in a tooth adjacent to the painful tooth with the open tooth cavity.
• Presence of concomitant oral pain due to any other condition such as: soft-tissue lesions (e.g., aphthous or traumatic ulcer, herpes labialis, acute necrotizing ulcerative gingivitis); or multiple hard-tissue (e.g., carious) lesions; pain due to other surgical procedures, injuries or dental surface sensitivity.
• Presence of a periodontal abscess as diagnosed from an X-ray or clinical examination of the painful tooth.
• Presence of glucose-6-phosphate dehydrogenase (G6PD) deficiency.
• History of acute or chronic hemolytic anemia.
• History of sensitivity or allergy to benzocaine or other local anesthetic agents.
• Use of any short-acting oral or topical analgesic/ anesthetic product within 2 hours of enrollment or any long-acting Rx or OTC analgesic product within 4 hours of enrollment.
• Use of an investigational drug or participation in an investigational study within the past 30 days.
• Previous participation in this study.
• Member or a relative of the study site staff or sponsor directly involved in the study.