Safety and efficacy of topical steroid administration in patients undergoing mandibular horizontal impacted wisdom tooth extraction

JRCT ID: jRCTs071210140

Registered date:28/03/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: mandibular horizontal impacted wisdom tooth
• Date of first enrollment: 28/03/2022
• Target sample size: 246
• Study type: Interventional

Intervention(s)

Intervention group: Insert of Solu-Cortef penetrated Spongel for post-extraction tooth socket, and close the wound
Control group: Insert of Spongel for post-extraction tooth socket, and close the wound

Outcome(s)

• Primary Outcome: postoperative pain (VAS)

Secondary Outcome

number of uses of analgesic drug
mental nerve hypoesthesia
lingual nerve hypoesthesia
trismus
swelling
dry socket
SSI
adverse study-drug event

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. patients who are planned to undergo mandibular horizontal impacted wisdom tooth extraction
2. Patients who can personally provide written consent at their own free will after being receiving a thorough explanation of the study and fully understanding their participation in the study.

Exclude criteria

Any of the following patients will be excluded:
1. Patients with problem in judgement.
2. Patients receiving therapies with anti-resorption drugs.
3. Patients with a history of radiation therapy to the jawbone.
4. Patients are immunocompromised with steroid or immunosuppressants.
5. Patients receiving therapies with antithrombotic therapy.
6. Patients for whom administration of Sol-Corteph, Spongel, Amoxicillin, Loxoprofen Sodium Hydrate or Acetaminophen is contraindicated.
7. Patients receiving therapies with Desmopressin Acetate Hydrate
8. Patients who receive analgesics for pain at least once a week (e.g., cancer pain, non-cancer pain). However, topical analgesics and anti-inflammatory drugs (patches and applications) are allowed.
9. Women who are or may be pregnant or lactating women.
10. Partients who are judged to be inappropriate to participate the study by the principal or cooperative doctors.

Related Information

• Primary Sponsor: Naruse Tomofumi