Antibiotic Efficacy in Third Molar Surgery
Public ClinicalTrials.gov record NCT00118820. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Despite over 50 years of antibiotic use and multiple clinical investigations (\>50), no definitive studies exist to confirm or refute the use of systemic antibiotics to prevent postoperative inflammatory complications after third molar (M3), aka "wisdom teeth" removal. Among patients having M3s extracted, does the administration of systemic prophylactic antibiotics when compared to placebo, decrease the rate of postoperative inflammatory complications? The first specific aim of the study is to implement a randomized, placebo-controlled clinical trial to determine if systemic prophylactic antibiotics, when compared to placebo, decrease the rate of postoperative alveolar osteitis (AO) after M3 extraction. For this proposal, postoperative AO is the primary outcome variable. The second specific aim is to implement a pilot study using a randomized, placebo-controlled clinical trial to determine if systemic prophylactic antibiotics, when compared to placebo, decrease the rate of postoperative infection after M3 extraction. For the purposes of this proposal, postoperative infection is a secondary outcome variable. Based on sample size estimates, we believe it will be necessary to implement a multi-year trial to address the second specific aim definitively. As such, we will use the experience and preliminary results derived from this clinical trial to develop and implement a future large scale clinical trial. The third specific aim is to identify risk factors associated with postoperative inflammatory complications in order to develop a model to predict if the prophylactic administration of antibiotics will prevent the postoperative inflammatory complications of alveolar osteitis and infection following the removal of M3's. The long-term goal of this project is to provide compelling clinical evidence to support recommendations regarding the use of systemic antibiotics in this setting and alter clinical practice based on the results of a well-done, definitive clinical investigation.
Study identification
- NCT ID
- NCT00118820
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 132 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 13 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 29, 2004
- Primary completion
- May 31, 2006
- Completion
- May 31, 2006
- Last update posted
- Jul 15, 2010
2004 – 2006
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Outpatient Clinic for Oral and Maxillofacial Surgery, Wang Pavilion, ACC230 | Boston | Massachusetts | 02114 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00118820, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 15, 2010 · Synced Sep 6, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00118820 live on ClinicalTrials.gov.