- 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
- 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.
- 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
- 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