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A phase 2, single-center, double-blind, randomized placebo-controlled, parallel-group comparison study of the efficacy and safety of Ibuprofen gargle in patients with unilateral lower wisdom tooth extraction

A phase 2, single-center, double-blind, randomized placebo-controlled, parallel-group comparison study of the efficacy and safety of Ibuprofen gargle in patients with unilateral lower wisdom tooth extraction

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2051250060
Enrollment
80
Registered
2025-06-30
Start date
2025-09-17
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pain after tooth extraction pain after tooth extraction

Interventions

20 mL of Ibuprofen or Placebo gargle solution per once. The daily dose is limited to 100 mL.

Sponsors

Kakei Yasumasa
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. The outpatient planned for unilateral lower wisdom tooth extraction under local anesthesia. 2. Adults more than 18 years of age (all genders) at the time of consent. 3. The patient planned stitch removal in a week after unilateral lower wisdom tooth extraction 4. The patient must have given his/her informed and signed consent

Exclusion criteria

Exclusion criteria: 1. The patient with peptic ulcers 2. The patient with a history of hypersensitivity to any component of the ibuprofen gargle such as ibuprofen, glycerin, or alcohol etc 3. The patient with impaired cardiac function or clinically significant heart disease 4. The patient with aspirin induced asthma or history of aspirin induced asthma 5. The patient with serious hematology abnormality 6. The patient with serious hepatic disease 7. The patient with serious kidney disease 8. The patient with serious hypertension 9. The patient is taking Zidovudine 10. Habitual use of local anesthetics, general anesthetics and analgesics including for cancer pain or non cancer pain used more than once a week. 11. The patient with dementia, psychiatric symptoms, drug addiction, or alcoholism that could interfere with assessments as investigators discretion. 12. Pregnant or lactating women 13. The patient participates or will participate in another study in another study 14. The patient who have used the investigational drug at least once during this clinical trial 15. The patient who is not qualified due to various reasons based on the investigators assessment

Design outcomes

Primary

MeasureTime frame
VAS score before and 15 min after the first use of IP gargle on PODs 2

Secondary

MeasureTime frame
VAS score before and 5 min after the use of IP gargle on POD 2. VAS score before and 5 min after the use of IP gargle on POD 1 VAS score before and 15 min after the use of IP gargle on POD 1

Contacts

Public ContactHiroshi Kita

Kobe University Hospital

ctrcpj-ibu1@med.kobe-u.ac.jp+81-78-382-6729

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026