Efficacy of Ibuprofen gargle for postoperative pain after impacted lower third molar extraction: A comparison study.

JRCT ID: jRCTs051210022

Registered date:10/05/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: third molar
• Date of first enrollment: 07/06/2021
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Ibuprofen gargle / placebo gargle

Outcome(s)

• Primary Outcome: 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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Kakei Yasumasa