Status:
COMPLETED
Antibiotic Efficacy in Third Molar Surgery
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Oral and Maxillofacial Surgery Foundation, Rosemont ,Illinois
Conditions:
Alveolar Osteitis
Dry Socket
Eligibility:
All Genders
13+ years
Phase:
PHASE3
Brief 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 inflammat...
Detailed Description
The management of impacted M3s is a high volume procedure. In the United States, the cost of M3 removal has been estimated to be over 2 billion dollars, not including costs for consults, x-rays, medic...
Eligibility Criteria
Inclusion
- Demographics: While all ages are eligible for study enrollment, as a practical matter, most patients having M3s removed are usually \> 13-14 years of age.
- Gender: Males and females will be offered to participate in this study.
- Race: All races and ethnicities are eligible for study enrollment.
- Clinical status: at least one impacted mandibular third molar ( M3 ) must be scheduled for extraction.
- Anesthesia: Patient request that the procedure be executed using intravenous sedation or general anesthesia. Intravenous sedation will be accomplished with use of an IV placed in the antecubital fossa of each patient
- Health status: Healthy patients or patients with mild systemic disease, i.e. ASA status \< 3, are eligible for study enrollment.
Exclusion
- Pre-existing infection: Infection is characterised as having an area with frank purulence and/or cellulitis characterized by erythema, induration and inability to open the mouth wide enough to provide access to the airway.
- Pre-existing Systemic Illness: as evidenced by severe dry mouth, patients who have undergone radiotherapy for oral cancer, patients that are immunocompromised, patients that require antibiotic prophylaxis for endocarditis, as well as, patients who are taking antimicrobials for other systemic diseases, i.e., uncontrolled diabetes., ASA status \> 2.
- Allergic Reactions to Medications: Patients who are allergic to Penicillin and Clindamycin will be excluded from the study.
- Anesthesia: Patient request that the operation be performed with local anesthesia without intravenous sedation or general anesthesia.
- Pregnancy: Pregnancy is a relative contraindication for study enrollment. If after consultation with the obstetrician, there is no contraindication to removing the impacted teeth with sedation or contraindication to receiving the test medications (penicillin or clindamycin) and the patient wants to pursue treatment, she would be considered eligible for study enrollment.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2006
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00118820
Start Date
March 1 2004
End Date
June 1 2006
Last Update
July 16 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Outpatient Clinic for Oral and Maxillofacial Surgery, Wang Pavilion, ACC230
Boston, Massachusetts, United States, 02114