NCT04598776

PMCF Study of CeraRoot Ceramic Implants One-piece: 3 Years Follow up

Post Market Clinical Follow up Study of CeraRoot Ceramic Implants One-piece: 3 Years Follow up

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 98 (actual)
• Sponsor: CeraRoot SL · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The main objective is to evaluate the success / failure rate of CeraRoot ceramic implants (one piece) during three year follow up.

Detailed description

Traditionally the material of choice for dental implants has been titanium. The success of such material has been unquestionable for the last decades. However a number of issues arise lately regarding the biocompatibility or cytotoxicity or allergies regarding the degradation or oxidation particles within the bone or gum. Esthetics has been a concern as well specially in patients with thin biotype where the metal may produce a grayish look of the mucosa. For this reason the dental community and patients have raised much interest in ceramic dental implants as a tooth colored and metal free alternative for dental implants. Since 2006 CeraRoot ceramic implants have been available in the market. The reason for designing this PMCF is to evaluate the long term success of CeraRoot ceramic implants To achieve those objectives an observational study of patients that have received such implant is designed, using marginal bone loss as a primary response variable. It is estimated that a sample size 200 patients over the 3 year period is needed to achieve relevant data.

Conditions

• Tooth Loss
• Ceramic Implant

Timeline

• Start date: 2020-08-27
• Primary completion: 2023-12-04
• Completion: 2023-12-31
• First posted: 2020-10-22
• Last updated: 2024-12-06
• Results posted: 2024-12-06

Locations

1 site across 1 country: Spain