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

October 21, 2024 updated by: CeraRoot SL

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

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

98

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Les Franqueses del Vallès, Barcelona, Spain, 08520
        • CeraRoot CLINIC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients that needed a tooth replacement that fulfilled the eligibility criteria.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Implants That Survived
Time Frame: Baseline to 3 years
Implant without pain, without mobility and in function.
Baseline to 3 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CeraRoot SL

Investigators

  • Principal Investigator: JOSEP OLIVA-OCHOA, MSC, CeraRoot SL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2020

Primary Completion (Actual)

December 4, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

September 13, 2020

First Submitted That Met QC Criteria

October 21, 2020

First Posted (Actual)

October 22, 2020

Study Record Updates

Last Update Posted (Actual)

December 6, 2024

Last Update Submitted That Met QC Criteria

October 21, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200806

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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