Prophylactic Effects for Preventing Surgical Site Infection in Third Molar Surgery

NCT06368102 | Completed Phase 4

• 1 other identifier: R6-03
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the incidence of surgical site infection (SSIs) after third molar surgery for different duration of intravenous ampicillin administration.

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

• Occurrence of surgical site infection

  is evaluated based on the guidelines by the Center for Disease Control and Prevention (CDC) and Clavien-Dindo classification system: within 30 days postoperatively, drainage from a surgical wound or abscess, requiring treatment with antimicrobial agents.

  30 days

Secondary Outcomes (1)

• Occurrence of alveolar osteitis

  7 days

Study Arms (2)

1day-group

EXPERIMENTAL

Participants will receive 1g of IV ampicillin before surgery and 1 time after surgery on the day of surgery (total 2g)

Drug: Ampicillin

2day-group

EXPERIMENTAL

Participants will receive 1g of IV ampicillin before surgery and 2 times after surgery up to the next day (total 3g)

Drug: Ampicillin

Interventions

Ampicillin DRUG

Total 2g vs 3g

1day-group; 2day-group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uji Takeda Hospital: lead

Study Sites (1)

Uji Takeda Hospital

Uji, Japan

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Ampicillin

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Keita Kano, PhD

  Uji Takeda Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 16, 2024
• Study Start: May 2, 2024
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Locations

JP (1)