Ceramic Dental Implants for Tooth Loss
(240101 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares two types of ceramic dental implants to determine which lasts longer and has fewer complications. It examines one-piece and two-piece designs for individuals missing teeth or with unsalvageable teeth. The trial targets those with metal allergies who require an alternative to metal implants. Participants should have missing teeth and metal allergies but should not have issues like poor oral hygiene or conditions that make surgery risky. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking dental solution.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on anticoagulant medication, it might be a concern, so it's best to discuss this with the trial team.
What prior data suggests that these dental implant techniques are safe?
Research has shown that ceramic dental implants, such as the one-piece and two-piece CeraRoot implants, are generally safe for people. Studies have found that one-piece implants have a very low breakage rate of about 0.2% among all zirconia implant types, indicating their strength and favorable patient outcomes.
For the two-piece CeraRoot TL implants, less research is available, but FDA approval suggests they are safe and effective. However, fewer studies exist on the two-piece design compared to the one-piece implants.
Overall, both types of implants have demonstrated safety, though more information is available for one-piece implants. This suggests they are generally well-tolerated with few reported issues.12345Why are researchers excited about this trial?
Researchers are excited about ceramic dental implants because they offer a metal-free alternative to traditional titanium implants. Unlike the standard metal implants, ceramic implants are made from zirconia, which is biocompatible and can potentially reduce the risk of allergic reactions and inflammation. The study compares two-piece and one-piece ceramic implants, and each has its unique benefits: the two-piece design allows for more flexibility during placement, while the one-piece design can provide a more streamlined and potentially stronger integration with the jawbone. These features could lead to better long-term outcomes and improved patient satisfaction.
What evidence suggests that this trial's treatments could be effective for dental implants?
This trial will compare two types of ceramic dental implants: one-piece and two-piece. Studies have shown that one-piece ceramic dental implants have long-lasting durability. In one study, all one-piece zirconia implants remained in place after the study period. Another study found that 89.6% of these implants were successful over eight years. For two-piece ceramic implants, research indicates that 73% lasted at least five years. Both types of ceramic implants are reliable, but one-piece implants generally last longer.678910
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
Treatment
Participants receive CeraRoot ceramic dental implants, either one-piece or two-piece
Follow-up
Participants are monitored for complications such as implantitis, mucositis, pain, implant fracture, prosthetic fracture, and bone loss
What Are the Treatments Tested in This Trial?
Interventions
- Ceramic Dental Implants
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Two-piece CeraRoot TL dental implants
One-piece CeraRoot dental implants
Find a Clinic Near You
Who Is Running the Clinical Trial?
CeraRoot SL
Lead Sponsor
Citations
Evaluation of one-piece zirconia dental implants: An 8-year ...
The overall survival rate of 67 zirconia implants in 39 patients was 100%. The overall success rate was 89.6%.
One-piece versus two-piece ceramic dental implants
Moreover, recent studies indicate clearly that one-piece as well as two-piece ceramic implants show excellent clinical results. However, two- ...
Nº1 in Clinical Studies - For Professionals - CeraRoot
Conclusion: From this long-term investigation, it can be concluded that CeraRoot ceramic implants showed a 15-year long-term clinical performance with a ...
4.
journalimplantdent.springeropen.com
journalimplantdent.springeropen.com/articles/10.1186/s40729-025-00621-xProspective clinical study to evaluate the success and survival ...
The implant survival rate at 12 months was 60.9%. Nine implants were lost: two due to lack of osseointegration at re-entry, four due to mobility after loading, ...
Clinical outcomes of zirconia implants: a systematic review ...
The clinical outcomes observed for zirconia dental implants are very promising, although these have not yet been extensively studied as titanium alloy implants.
K181953 Trade/Device Nam - accessdata.fda.gov
SDS 1.2 Dental implants meet all requirements of the applicable standards listed in the table below. Page 12. 510(k) Summary. 510(k) Summary.
One-piece versus two-piece ceramic dental implants - PMC
This article will compare the benefits and drawbacks of one-piece versus two-piece ceramic implants based on clinical- (design, different sizes, surgical ...
Download
One piece zirconia implants for the replacement of single units: A case series · PDF_Logo ; JOMI(1), Five-year Success Rate of 831 Consecutively Placed Zirconia ...
Ceramic Implants FAQs – Metal-Free Dental Implants
SDS's zirconia implant 2019 annual assessment revealed a fracture rate of 0.2% across all zirconia implant types, both one and 2-piece implants, which is ...
ceramic implants - Zirconia Vs. Titanium
The main advantage of a one-piece zirconia implant is that it has no prosthetic connections, where bacteria can grow, and therefore have better gum health.
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