Preventing infections after wisdom tooth surgery
Prophylactic Effects of Different Duration of Intravenous Ampicillin for Preventing Surgical Site Infection in Third Molar Surgery: a Randomized Controlled Trial
PHASE4 · Uji Takeda Hospital · NCT06368102
This study is testing how long to give antibiotics after wisdom tooth surgery to see if it helps prevent infections.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Uji Takeda Hospital (other) |
| Locations | 1 site (Uji) |
| Trial ID | NCT06368102 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of different durations of intravenous ampicillin administration in preventing surgical site infections (SSIs) following third molar surgery. It addresses the growing concern of drug-resistant bacteria and the inappropriate use of antimicrobial agents, which can lead to severe health consequences. Participants will be monitored for the incidence of SSIs post-surgery to determine the optimal duration of antibiotic prophylaxis. The study is conducted in an inpatient setting under IV sedation, ensuring controlled conditions for patient safety and data accuracy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 and older who are scheduled for bilateral mandibular third molar extraction requiring bone removal.
Not a fit: Patients with a history of surgical site infection risk factors, active infections, or allergies to ampicillin may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of surgical site infections in patients undergoing third molar surgery.
How similar studies have performed: Other studies have shown varying success with antibiotic prophylaxis in surgical settings, but this specific approach to third molar surgery is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Minimum age of 20 years * American Society of Anesthesiologists (ASA) physical status of 1 * Planned extraction of bilateral mandibular third molar with the necessity of bone removal based on panoramic radiography in an inpatient setting under IV sedation * Agreement to follow the study protocol Exclusion Criteria: * Pregnancy or suspicion of pregnancy * Allergy and/or contraindication to ampicillin * History of a known SSI risk factors, such as diabetes, steroid or immunosuppressant use, and endocarditis * Receiving any antibiotic therapy * Active infection of the third molars with pus, edema, and trismus
Where this trial is running
Uji
- Uji Takeda Hospital — Uji, Japan (RECRUITING)
Study contacts
- Study coordinator: Keita Kano, PhD
- Email: k-kano@takedahp.or.jp
- Phone: +81774252500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Surgical Site Infection