Clinical research of filling extraction sockets with selective COX2 inhibitor-containing paste in patients with mandibular wisdom tooth extractions.

JRCT ID: jRCTs051230162

Registered date:11/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: third molar
• Date of first enrollment: 11/01/2024
• Target sample size: 12
• Study type: Interventional
• Intervention(s): Paste containing selective COX2 inhibitors

Outcome(s)

• Primary Outcome: presence of dry socket by Day 8

Secondary Outcome

1. Overall daily VAS on PODs 1 to 5.
2. Number of uses (analgesic drug) per day on PODs 1 to 5.
3. Time to analgesic drug on PODs 1 to 5.
4. Overall daily efficacy on PODs 1 to 5.
5. Adverse Event and Serious Adverse Event

Key inclusion & exclusion criteria

• Age minimum: >= 18age 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 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.

Exclude 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.

Related Information

• Primary Sponsor: Kakei Yasumasa