PMCF Study of CeraRoot Ceramic Implants One-piece: 1year, 5 Years Follow up

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

Detailed Description
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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 5 year period is needed to achieve relevant data.

Official Title
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Post Market Clinical Follow up Study of CeraRoot Ceramic Implants One-piece: One Year and Five Years Follow up

Conditions
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Tooth Loss, Ceramic Implant

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients that have received the studied ceramic implant after 27 August 2020. Patients of CeraRoot Clinic (Barcelona) Age >18 Single or multiple missing or hopeless teeth 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survival | Implant without pain, without mobility and in function. | Baseline to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical complications (SC) | Any complications, as bleeding, infection, no primary stability, early loss.... that may appear will be collected | Baseline to 7 days | 
| Before loading implants Complications (BLIC) | Any complications before the prosthesis is delivered (implant mobility, implant infection, implant loss...) will be collected | 7 days post operative to delivery of prosthesis | 
| After loading implants Complications (ALIC) | Any complications after the prosthesis is delivered (implant loss, bone loss, implant mobility...) that may appear will be recorded. | Baseline to 5 years | 
| Prosthetic Complications (PC) | Any difficulty during the confection of the crown, complications as decementation, chipping, etc... will be registered. | Baseline to 5 years | 
| Implant Success | Implant survival in addition to not having bone loss around it. | Baseline to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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zirconia implant, zirconium oxide implant, dental implant, ceramic implant, CeraRoot, one-piece, monotype