Microbial Sampling for Gum Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how the tiny organisms in the mouth change when individuals with severe gum disease transition from having some teeth to no teeth and then receive dental implants. It compares different implant types to assess their impact on these changes. Individuals with advanced gum disease who need all their teeth replaced by implants might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to pioneering research in dental health.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on antibiotics, steroids, or investigational drugs, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that Intra-Lock Fusion Implants are safe and well-tolerated. They are designed to ensure a successful dental implant procedure. The FDA has approved these implants for both single and multiple tooth replacements, confirming they meet specific safety standards.
Research on Tapered Pro Implants also indicates safety. Part of the BioHorizons system, these implants are designed for placement in the jawbone. They have demonstrated safety comparable to other products, suggesting reliability.
Overall, both Intra-Lock Fusion and Tapered Pro Implants prioritize safety, with no major safety concerns reported in the available data.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores how dental implants, specifically Intra-Lock Fusion Implants and Tapered Pro Implants, impact oral microbial status. Unlike standard dentures or bridges that don't integrate with the bone, these implants are designed to fuse directly with the jawbone, potentially providing a more stable and long-lasting solution. This trial seeks to understand whether these specific implants can lead to healthier microbial environments in the mouth, compared to edentulous or natural tooth conditions. By studying these changes, researchers hope to uncover insights into improving oral health and longevity of dental implants.
What evidence suggests that this trial's implant treatments could be effective for severe periodontitis?
In this trial, participants will receive either Intra-Lock Fusion Implants or Tapered Pro Implants. Research has shown that Intra-Lock Fusion Implants are highly reliable, achieving a 100% success rate over five years for straight placements and 98.44% for angled placements. These implants effectively support the replacement of one or more teeth and integrate well with the jawbone.
For participants receiving Tapered Pro Implants, data indicates a high success rate, with 97.8% lasting five years. They help maintain bone stability around the implant over time. Additionally, a five-year study found a 99.2% success rate, underscoring their reliability for dental work.12678Who Is on the Research Team?
Gian Pietro Schincaglia, DDS,PhD
Principal Investigator
Case Western Reserve University
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline and Extractions
Baseline microbial sampling and full mouth extractions are performed. An immediate denture may be delivered.
Diagnostics for Implant Placement
Diagnostics for implant placement including CBCT and provisional denture adjustments.
Implant Placement
Mucosal-oral microbial sampling and implant placement. Implants are submerged for healing.
Follow-up after Implant Placement
Follow-up and suture removal 14 days after implant placement.
Implant Uncover
Abutments are connected to the implants after a second stage uncover surgery.
Follow-up after Implant Uncover
Follow-up and suture removal 14 days after implant uncover procedure.
Restorative Connection
Permanent abutments are connected to the implants and microbial samples are collected.
Post-loading Follow-up
6 months post-loading, microbial sampling and clinical assessments are performed.
Long-term Follow-up
12 months post-loading, microbial sampling and clinical assessments are performed.
What Are the Treatments Tested in This Trial?
Interventions
- Microbial Sampling
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
These patients will receive Tapered Pro Implants during implant placement
These patients will receive Intra-Lock Fusion Implants during implant placement
Find a Clinic Near You
Who Is Running the Clinical Trial?
Case Western Reserve University
Lead Sponsor
Citations
What Is the Survival Rate of Implants Loaded Immediately ...
The overall 5-year survival rate of the implants was 100% for the axially placed implants and 98.44% for the obliquely placed implants. Implant survival rates ...
Fusion
Fusion implants by Intra-Lock offer a unique combination of features that have been carefully designed to deliver successful dental implant treatment.
A Comparison of Conical and Cylindrical Implants Inserted ...
On the other hand, INTRALOCK implants reported the highest results in the block of 20 PCF density with the cortical sheet but showing a statistical significance ...
Intra-Lock® Dental Implants - accessdata.fda.gov
The implants have been designed to be used in either the mandible or the maxilla and to support removable or fixed prostheses, from single tooth.
The effect of implant design on insertion torque and ...
The use of dental implants to replace missing teeth has become a safe treatment modality over the last four decades (Chuang et al. 2001). De- spite the ...
Home Page - INTRA-LOCK
Fusion implants offer novel technologies and new workflows with the time-tested design features of Intra-Lock implants.
Intra-Lock System International Dental Implants
Fusion implants, which are built with time-tested design features of Intra-Lock implants, offer novel technologies and new workflows. Spotimplant's Services.
8.
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cdn.sicat.com/sicat/website/downloads/implantologie/implant-database/SICATImplantDatabase_ReleaseNotes_2023-08-23.pdfIMPLANT DATABASE - SICAT
Implant One. Standard Implants. Wide Implants. Intra-Lock. Fusion. MDL. MDL 15°. MILO. MILO (Long collar). One-Piece Tapered. IPPON. Screw.
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