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

CeraRoot SL98 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Tooth Loss Ceramic Implant

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

CeraRoot CLINIC

Les Franqueses del Vallès, Barcelona, Spain

Outcomes

Primary Outcomes

Number of Implants That Survived

Implant without pain, without mobility and in function.

Time frame: Baseline to 3 years

Secondary Outcomes

Number of Implants With Surgical Complications (SC)

Any complications, as bleeding, infection, no primary stability, early loss.... that may appear will be collected

Time frame: Baseline to 7 days

Number of Implants With Before Loading Implants Complications (BLIC)

Any complications before the prosthesis is delivered (implant mobility, implant infection, implant loss...) will be collected

Time frame: 7 days post operative to delivery of prosthesis

Number of Implants With After Loading Implants Complications (ALIC)

Any complications after the prosthesis is delivered (implant loss, bone loss, implant mobility...) that may appear will be recorded.

Time frame: From delivery of prosthesis to two years later.

Number of Units With Prosthetic Complications (PC)

Any difficulty during the confection of the crown, complications as decementation, chipping, etc... will be registered.

Time frame: Baseline to 3 years

Data from ClinicalTrials.gov

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