JPRN-jRCTs051230162
Recruiting
Phase 1
Phase I, open-label, single-arm study to evaluate the safety of filling extraction sockets with selective COX2 inhibitor-containing paste in patients with extracted mandibular wisdom teeth
Kakei Yasumasa0 sites12 target enrollmentJanuary 11, 2024
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- third molar
- Sponsor
- Kakei Yasumasa
- Enrollment
- 12
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 scheduled for extraction of wisdom teeth classified as Class I and II in the Pell\-Gregory classification (horizontal position)
- •(3\) Patients scheduled for extraction of wisdom teeth classified as Positions A and B in the Pell\-Gregory classification (vertical position)
- •(4\) Patients aged 18 years or older at the time of acquisition consent.
- •(5\) Patients for whom documented consent has been obtained regarding their voluntary participation in
- •this clinical study.
Exclusion Criteria
- •(1\) Patients with concurrent severe or uncontrolled concomitant medical conditions.
- •(2\) Patients with history of hypersensitivity to any component of selective COX2 inhibitor, Tween80, Hydroxypropyl cellulose, PEG400\.
- •(3\) Patients with aspirin\-induced asthma.
- •(4\) Patients who use analgesic drug at least once a week for any chronic pain.
- •(5\) Patients with dementia, psychiatric symptoms, drug addiction and alcoholism
- •(6\) Pregnant or lactating women.
- •(7\) Patients undergoing radiotherapy at the site of a planned wisdom tooth extraction
- •(8\) Patients with a history of drug administration related to medication\-related osteonecrosis of the jaw
- •(9\) Patients that the investigator deems inappropriate.
Outcomes
Primary Outcomes
Not specified
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