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

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Smokers.
The patient is taking medications or having treatments which have an effect on healing in general (e.g. steroids, large doses of anti-inflammatory drugs).
Untreated periodontal conditions

Primary Outcome Measures

Name	Time	Method
Number of Implants That Survived	Baseline to 3 years	Implant without pain, without mobility and in function.

Secondary Outcome Measures

Name	Time	Method
Number of Implants With Surgical Complications (SC)	Baseline to 7 days	Any complications, as bleeding, infection, no primary stability, early loss.... that may appear will be collected
Number of Implants With Before Loading Implants Complications (BLIC)	7 days post operative to delivery of prosthesis	Any complications before the prosthesis is delivered (implant mobility, implant infection, implant loss...) will be collected
Number of Implants With After Loading Implants Complications (ALIC)	From delivery of prosthesis to two years later.	Any complications after the prosthesis is delivered (implant loss, bone loss, implant mobility...) that may appear will be recorded.
Number of Units With Prosthetic Complications (PC)	Baseline to 3 years	Any difficulty during the confection of the crown, complications as decementation, chipping, etc... will be registered.