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Completed

NCT Number: NCT04598776

PMCF 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.

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Key information

Conditions

Tooth Loss Ceramic Implant Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CeraRoot CLINIC

Les Franqueses del Vallès, Barcelona, 08520, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of Implants That Survived

    Time frame: Baseline to 3 years

    Implant without pain, without mobility and in function.

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

CeraRoot SL

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 22, 2020
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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