JPRN-jRCTs051230162招募中1 期
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 个研究点目标入组 12 人开始时间: 2024年1月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(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.
排除标准
- •(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.
研究者
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