Alveolar OsteitisPhase 3NCT00118820
Antibiotic Efficacy in Third Molar Surgery
A Phase 3 study of Alveolar Osteitis and Dry Socket, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Osteitis, Dry Socket, Infection
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Jun 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Outpatient Clinic for Oral and Maxillofacial Surgery, Wang Pavilion, ACC230
Boston, Massachusetts, 02114
About this study
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.
Read more
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.
Read the 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, medications, surgical center charges, or over 5 million surgical extractions and treatment of postoperative inflammatory complications (Flick. 1999). Practices associated with M3 removal can have a significant impact on large numbers of patients, providers, and payers. There is currently no consensus on the use of systemic antibiotic prophylaxis to decrease the risk of inflammatory complications following M3 removal.The most common post-operative inflammatory complications following M3 extraction are alveolar osteitis (AO) and wound infection (Larsen, 1992; Piecuch et al., 1995; Sekar et al., 2001). AO, aka "dry socket," is a wound-healing problem characterized by severe, unremitting pain. The reported frequency of AO is 6-68%. Bacterial colonization stimulates plasmin production and fibrinolysis with dissolution of the extraction site clot . More than 45% of patients who sustain AO require 4 or 5 more postoperative appointments for resolution of symptoms (Larsen, 1992; Andra et al., 1990). Given its common occurrence, identifying treatments, i.e. systemic antibiotics, to decrease the rate of AO following M3 extraction would be an important contribution to enhancing patient outcomes. The second common postoperative inflammatory condition following M3 extraction is wound infection. The reported frequency of postoperative infection ranges from 1.2 - 27%, with most studies reporting a frequency of <10%. Because wound infections are bacterial, it is hypothesized that using systemic antibiotics will reduce the rate of postoperative wound infections. There are, however, no definitive prospective studies that support or refute the necessity of systemic antibiotics in the prevention of postoperative inflammatory complications of AO or infection.
All studies published to date addressing the role of systemic antibiotics and M3 removal have one or more major methodological flaws in study design characterized as :1) no or ambiguous definition of the outcome variable, 2) inadequate sample size, 3) non-uniformity of protocol design, 4) lack of randomization techniques and 5) poor-follow-up monitoring. Clearly, there is a need for a definitive, rigorous, well-designed placebo-controlled randomized clinical trial to ascertain the efficacy of systemic antibiotics in preventing postoperative inflammatory complications after M3 removal.
.
- Conditions
- Alveolar Osteitis, Dry Socket, Infection
- Being tested
- IV Preoperative antibiotic or placebo
- Keywords
- Dry socket, Third molar, Infection, postop-infection, Antibiotic efficacy, Infection characterized by pus,erythema,edema and pain
- Medical subject headings
- Dry Socket, Infections, Edema, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV Preoperative antibiotic or placeboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of postoperative inflammatory complication: i.e., alveolar osteitis or infection
Secondary outcomes (1)
Adverse effects from treatment: i.e., antibiotic administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2005 (estimated)
- Study startMar 2004
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar OsteitisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oral and Maxillofacial Surgery Foundation, Rosemont ,Illinois
- Investigators
- Thomas B Dodson, DMD,MPH, Principal investigator, Massachusetts General HospitalLeslie R Halpern, DDS,MD,MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00118820
- Sponsor's protocol ID
- 2002-P000048/11
- Status last verified
- Jul 2010
- First submitted
- 1 Jul 2005
- Last updated
- 16 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Efficacy in Third Molar Surgery
- ClinicalTrials.gov ID
- NCT00118820
- Acronym / sponsor ID
- 2002-P000048/11
- Conditions
- Alveolar Osteitis, Dry Socket, Infection
- Keywords
- Dry socket, Third molar, Infection, postop-infection, Antibiotic efficacy, Infection characterized by pus,erythema,edema and pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Oral and Maxillofacial Surgery Foundation, Rosemont ,Illinois
- Study start
- Mar 2004
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 12 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, medications, surgical center charges, or over 5 million surgical extractions and treatment of postoperative inflammatory complications (Flick. 1999). Practices associated with M3 removal can have a significant impact on large numbers of patients, providers, and payers. There is currently no consensus on the use of systemic antibiotic prophylaxis to decrease the risk of inflammatory complications following M3 removal.The most common post-operative inflammatory complications following M3 extraction are alveolar osteitis (AO) and wound infection (Larsen, 1992; Piecuch et al., 1995; Sekar et al., 2001). AO, aka "dry socket," is a wound-healing problem characterized by severe, unremitting pain. The reported frequency of AO is 6-68%. Bacterial colonization stimulates plasmin production and fibrinolysis with dissolution of the extraction site clot . More than 45% of patients who sustain AO require 4 or 5 more postoperative appointments for resolution of symptoms (Larsen, 1992; Andra et al., 1990). Given its common occurrence, identifying treatments, i.e. systemic antibiotics, to decrease the rate of AO following M3 extraction would be an important contribution to enhancing patient outcomes. The second common postoperative inflammatory condition following M3 extraction is wound infection. The reported frequency of postoperative infection ranges from 1.2 - 27%, with most studies reporting a frequency of <10%. Because wound infections are bacterial, it is hypothesized that using systemic antibiotics will reduce the rate of postoperative wound infections. There are, however, no definitive prospective studies that support or refute the necessity of systemic antibiotics in the prevention of postoperative inflammatory complications of AO or infection.
All studies published to date addressing the role of systemic antibiotics and M3 removal have one or more major methodological flaws in study design characterized as :1) no or ambiguous definition of the outcome variable, 2) inadequate sample size, 3) non-uniformity of protocol design, 4) lack of randomization techniques and 5) poor-follow-up monitoring. Clearly, there is a need for a definitive, rigorous, well-designed placebo-controlled randomized clinical trial to ascertain the efficacy of systemic antibiotics in preventing postoperative inflammatory complications after M3 removal.
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV Preoperative antibiotic or placebo | Drug | – |
Primary outcome
Presence or absence of postoperative inflammatory complication: i.e., alveolar osteitis or infection
1 secondary outcome
Adverse effects from treatment: i.e., antibiotic administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas B Dodson, DMD,MPH principal investigator
Massachusetts General Hospital
Leslie R Halpern, DDS,MD,MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Alveolar Osteitis and Dry Socket, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of postoperative inflammatory complication: i.e., alveolar osteitis or infection. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2010.