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NCT00118820 · ClinicalTrials.gov registry record · Phase 3
Antibiotic Efficacy in Third Molar Surgery
A Phase 3 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 132
- Enrollment target
NCT00118820: Completed Phase 3 study, sponsored by Massachusetts General Hospital.
NCT00118820 is a Phase 3 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 132 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00118820, a Phase 3 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 132 participants
- Enrollment target
Study Summary
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 inv
Interventions
- DRUG IV Preoperative antibiotic or placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2004-03 |
| Est. Completion | 2006-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00118820
The ClinicalTrials.gov registry entry for NCT00118820 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which IV Preoperative antibiotic or placebo is the first listed.
NCT00118820 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00118820 about?
NCT00118820 is a clinical study titled "Antibiotic Efficacy in Third Molar Surgery". 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 extr...
What is the current status of trial NCT00118820?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 132 participants. The study started on 2004-03. Estimated completion is 2006-06.
What interventions are being tested in trial NCT00118820?
The interventions under investigation include: IV Preoperative antibiotic or placebo (DRUG).
Who is sponsoring clinical trial NCT00118820?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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