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

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

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs051230162
Enrollment
18
Registered
2024-01-11
Start date
2024-04-01
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

third molar wisdom tooth extraction

Interventions

Paste containing selective COX2 inhibitors

Sponsors

Kakei Yasumasa
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
presence of dry socket by Day 8

Secondary

MeasureTime frame
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

Contacts

Public ContactKaito Uryu

Kobe University Hospital

uryu@med.kobe-u.ac.jp+81-78-382-6213

Outcome results

None listed

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