Post Market Clinical Follow up Study of CeraRoot Ceramic Implants One-piece: 3 Years Follow up
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Tooth Loss
- Sponsor
- CeraRoot SL
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- Number of Implants That Survived
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients that have received the studied ceramic implant after 27 August
- •Patients of CeraRoot Clinic (Barcelona)
- •Single or multiple missing or hopeless teeth
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Number of Implants That Survived
Time Frame: Baseline to 3 years
Implant without pain, without mobility and in function.
Secondary Outcomes
- Number of Implants With Surgical Complications (SC)(Baseline to 7 days)
- Number of Implants With Before Loading Implants Complications (BLIC)(7 days post operative to delivery of prosthesis)
- Number of Implants With After Loading Implants Complications (ALIC)(From delivery of prosthesis to two years later.)
- Number of Units With Prosthetic Complications (PC)(Baseline to 3 years)