third molar wisdom tooth extraction
Conditions
Sponsors
Kakei Yasumasa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients who were planning to have a lower third molar extraction and who were expected to register on the day of extraction.. (2) Patients aged 20 years or older at the time of acquisition consent. (3) Patients for whom documented consent has been obtained regarding their voluntary participation in this clinical study.
Exclusion criteria
Exclusion criteria: (1) Patients who have peptic ulcer. (2) Patients with concurrent severe or uncontrolled concomitant medical conditions. (3) Patients with history of hypersensitivity to any component of ibuprofen gargle. (4) Patients who impaired cardiac function or clinically significant heart disease. (5) Patients with aspirin-induced asthma. (6) Patients who use analgesic drug at least once a week for any chronic pain. (7) Patients with dementia, psychiatric symptoms, drug addiction and alcoholism. (8) Pregnant or lactating women. (9) Patients that the investigator deems inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in VAS before and after 5 minutes of use of the first ibuprofen or placebo gargle on PODs 1 and 2 (delta VAS 5) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Delta VAS before and 15 minutes after the first use of ibuprofen or placebo gargle on PODs 1 and 2. 2. Delta VAS before and after 5 and 15 minutes of use of the first ibuprofen gargle on PODs 3 through 5. 3. Overall daily efficacy on PODs 1 to 5. 4. Number of uses (gargle, analgesic drug) per day on PODs 1 to 7. 5. Adverse Event | — |
Contacts
Public ContactTakeshi Ioroi
Kobe University Hospital
Outcome results
None listed