AzTrials
AzTrials

Tooth LossNCT04598776

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

An observational study of Tooth Loss and Ceramic Implant, run by CeraRoot SL at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Tooth Loss, Ceramic Implant
How many people
98 participants
Where
1 siteSpain
Study dates
27 Aug 2020to 31 Dec 2023
How long will I take part?
3 Years
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients that needed a tooth replacement that fulfilled the eligibility criteria.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • CeraRoot CLINIC

    Les Franqueses del Vallès, Barcelona, 08520

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Keywords
zirconia implant, zirconium oxide implant, dental implant, ceramic implant, CeraRoot, one-piece, monotype
Medical subject headings
Tooth Loss

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Implants That Survived

    Implant without pain, without mobility and in function.

    Measured: Baseline to 3 years

Secondary outcomes (4)

  1. Number of Implants With Surgical Complications (SC)

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

    Measured: Baseline to 7 days

  2. 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

    Measured: 7 days post operative to delivery of prosthesis

  3. 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.

    Measured: From delivery of prosthesis to two years later.

  4. Number of Units With Prosthetic Complications (PC)

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

    Measured: Baseline to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2020
  2. Study start27 Aug 2020
  3. Primary completion4 Dec 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
98 participants (actual)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04598776
Sponsor's protocol ID
200806
Status last verified
Oct 2024
First submitted
13 Sep 2020
Last updated
6 Dec 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Gahlert M, Roehling S, Sprecher CM, Kniha H, Milz S, Bormann K. In vivo performance of zirconia and titanium implants: a histomorphometric study in mini pig maxillae. Clin Oral Implants Res. 2012 Mar;23(3):281-6. doi: 10.1111/j.1600-0501.2011.02157.x. Epub 2011 Aug 2.

    PubMed 21806681

  • Kohal RJ, Knauf M, Larsson B, Sahlin H, Butz F. One-piece zirconia oral implants: one-year results from a prospective cohort study. 1. Single tooth replacement. J Clin Periodontol. 2012 Jun;39(6):590-7. doi: 10.1111/j.1600-051X.2012.01876.x. Epub 2012 Apr 23.

    PubMed 22519944

  • Payer M, Arnetzl V, Kirmeier R, Koller M, Arnetzl G, Jakse N. Immediate provisional restoration of single-piece zirconia implants: a prospective case series - results after 24 months of clinical function. Clin Oral Implants Res. 2013 May;24(5):569-75. doi: 10.1111/j.1600-0501.2012.02425.x. Epub 2012 Feb 15.

    PubMed 22335358

  • Gahlert M, Burtscher D, Pfundstein G, Grunert I, Kniha H, Roehling S. Dental zirconia implants up to three years in function: a retrospective clinical study and evaluation of prosthetic restorations and failures. Int J Oral Maxillofac Implants. 2013 May-Jun;28(3):896-904. doi: 10.11607/jomi.2211.

    PubMed 23748325

  • Siddiqi A, Kieser JA, De Silva RK, Thomson WM, Duncan WJ. Soft and Hard Tissue Response to Zirconia versus Titanium One-Piece Implants Placed in Alveolar and Palatal Sites: A Randomized Control Trial. Clin Implant Dent Relat Res. 2015 Jun;17(3):483-96. doi: 10.1111/cid.12159. Epub 2013 Sep 23.

    PubMed 24112624

  • Hashim D, Cionca N, Courvoisier DS, Mombelli A. A systematic review of the clinical survival of zirconia implants. Clin Oral Investig. 2016 Sep;20(7):1403-17. doi: 10.1007/s00784-016-1853-9. Epub 2016 May 24.

    PubMed 27217032

  • Oliva J, Oliva X, Oliva JD. Five-year success rate of 831 consecutively placed Zirconia dental implants in humans: a comparison of three different rough surfaces. Int J Oral Maxillofac Implants. 2010 Mar-Apr;25(2):336-44.

    PubMed 20369093

  • Oliva J, Oliva X. 15-Year Post-Market Clinical Follow-up Study of 1,828 Ceramic (Zirconia) Implants in Humans. Int J Oral Maxillofac Implants. 2023 Mar-Apr;38(2):357-366. doi: 10.11607/jomi.10000.

    PubMed 37083912

Questions about this trial

What is this clinical trial studying?

An observational study of Tooth Loss and Ceramic Implant, run by CeraRoot SL at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Implants That Survived (time frame: Baseline to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04598776, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in