Intraosseous Antibiotics for Peri-Implantitis
(IOAOI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the safety and effectiveness of delivering antibiotics directly into the bone for individuals with infections around their osseointegration implants. Osseointegration connects a prosthetic limb directly to the bone. The study includes two groups: one group will be observed, while the other will receive bone-delivered antibiotics if surgery becomes necessary. Suitable participants have undergone osseointegration after amputation and now face potential infection at the surgical site.
As an unphased trial, this study provides a unique opportunity to contribute to innovative treatment approaches for infection management.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that intraosseous antibiotic delivery is safe for osseointegration patients?
Research has shown that using antibiotics directly in the bone during dental procedures can help prevent infections. Understanding the safety of this method for patients is crucial. One study found that dental implants treated with clindamycin, an antibiotic, were more likely to fail compared to those treated with amoxicillin. This suggests that the choice of antibiotic can impact treatment success.
Another review indicated that administering antibiotics before a dental procedure can help implants last longer. Specifically, taking a single dose of antibiotics before the procedure reduced the chance of implant failure. However, routinely giving antibiotics to all patients receiving dental implants does not always prevent failures or infections in healthy individuals.
In summary, while antibiotics can help prevent infections, their use should be carefully considered to avoid unnecessary risks. Patients should consult their healthcare provider to understand the safest options.12345Why are researchers excited about this trial?
Researchers are excited about the intraosseous antibiotic delivery technique for peri-implantitis because it offers a targeted approach by delivering antibiotics directly into the bone, right where the infection is happening. Unlike traditional treatments that often rely on oral antibiotics or surgical debridement, this method aims to enhance the effectiveness of the medication by concentrating it at the infection site, potentially reducing the need for more invasive procedures. This focused delivery could lead to faster healing and less systemic exposure to antibiotics, which is a significant advantage over current methods.
What evidence suggests that intraosseous antibiotic delivery is effective for peri-implantitis?
Research has shown that antibiotics during dental implant procedures can reduce the risk of implant failure. One study found that antibiotics significantly lowered this risk. Another review demonstrated that taking antibiotics before the procedure resulted in fewer failures compared to not using them. While antibiotics aren't always necessary for routine dental implants, they are recommended when there's a risk of infection, such as inflammation around an implant. In this trial, one group will receive intraosseous antibiotics for osseointegration, applying antibiotics directly to the bone to manage infections during implant surgeries. Another group will be observational, consisting of patients who do not require surgery for infection.12367
Who Is on the Research Team?
Joseph R Hsu, MD
Principal Investigator
Wake Forest University Health Sciences
Are You a Good Fit for This Trial?
This trial is for people who have had an implant placed in their bone (osseointegration) and may be at risk of infection around the implant. Specific inclusion or exclusion criteria are not listed, so eligibility will depend on further screening by the study team.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Observational
Participants are monitored for infection characteristics without intervention
Interventional
Participants requiring surgery receive intraosseous antibiotics to assess safety and feasibility
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Intraosseous Antibiotic Delivery
Trial Overview
The study is testing how safe and effective it is to deliver antibiotics directly into the bone (intraosseous delivery) to prevent or treat infections around implants.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patients that require surgery for infection
Patients that do not require surgery for infection
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
United States Department of Defense
Collaborator
Citations
Comparing the Impact of Pre-Operative Antibiotics on ... - PMC
Implants in the clindamycin group demonstrated a significantly higher risk of failure (HR: 3.70, p < 0.001) compared to the amoxicillin group.
A Systematic Review of Antibiotic Use in Dental Implant ...
If no antibiotics were administered, the risk of post-periodontal surgery infections varies from 1% to 4.4% for periodontal surgery and 4.5% ...
Efficacy and safety of using antibiotics to prevent post- ...
The guidelines do not support the use of antibiotics for routine dental implant placement but recommend the use of Amoxicillin 3 g (or ...
4.
pocketdentistry.com
pocketdentistry.com/do-antibiotics-decrease-implant-failure-and-postoperative-infections-a-systematic-review-and-meta-analysis/Do antibiotics decrease implant failure and postoperative ...
Antibiotic use significantly lowered the implant failure rate ( P = 0.003), with an odds ratio of 0.331, implying that antibiotic treatment ...
5.
athenaeumpub.com
athenaeumpub.com/antibiotics-prescription-impact-on-late-dental-implants-survival/Impact on Late Dental Implants Survival
A significant difference in implant failure was found when comparing preoperative antibiotic coverage at any dose (4.6% failures) and no ...
6.
glidewelldental.com
glidewelldental.com/education/integrate-magazine/volume-1-issue-1/prophylactic-antibiotic-use-in-implant-dentistryProphylactic Antibiotic Use in Implant Dentistry (1 CEU)
After an implant failure and removal, studies have shown that the success rate of the implant replacement drops to 71% and drops further to only ...
Antibiotic prophylaxis in dental implant surgery
The findings show that routine antibiotic prophylaxis does not significantly reduce implant failure or postoperative infections in healthy ...
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