Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00118820
Status:
COMPLETED
Last Update Posted:
2010-07-16
First Post:
2005-07-01
Brief Title:
Antibiotic Efficacy in Third Molar Surgery
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Antibiotic Efficacy in Third Molar Surgery
Status:
COMPLETED
Status Verified Date:
2010-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 M3s
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
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 M3s
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 removalThe 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 ie 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 12 - 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None