Antibiotic Efficacy in Third Molar Surgery

NCT00118820 | Completed Phase 3

• 1 other identifier: 2002-P000048/11
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Alveolar Osteitis; Dry Socket; Infection

Keywords

Dry socket; Third molar; Infection; postop-infection; Antibiotic efficacy; Infection characterized by pus,erythema,edema and pain

Outcome Measures

Primary Outcomes (1)

• Presence or absence of postoperative inflammatory complication: i.e., alveolar osteitis or infection

Secondary Outcomes (1)

• Adverse effects from treatment: i.e., antibiotic administration

Interventions

IV Preoperative antibiotic or placebo DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Oral and Maxillofacial Surgery Foundation, Rosemont ,Illinois: collaborator

Study Sites (1)

Outpatient Clinic for Oral and Maxillofacial Surgery, Wang Pavilion, ACC230

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Dry Socket; Infections; Edema; Pain

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Study Officials

• Thomas B Dodson, DMD,MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Leslie R Halpern, DDS,MD,MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 1, 2005
• First Posted: July 12, 2005
• Study Start: March 1, 2004
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: July 16, 2010

Record last verified: 2010-07

Locations

US (1)