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

NCT ID: NCT04598776

Last Updated: 2024-12-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

98 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-27

Study Completion Date

2023-12-31

Brief Summary

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The main objective is to evaluate the success / failure rate of CeraRoot ceramic implants (one piece) during three 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 3 year period is needed to achieve relevant data.

Conditions

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Tooth Loss Ceramic Implant

Keywords

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zirconia implant zirconium oxide implant dental implant ceramic implant CeraRoot one-piece monotype

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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CeraRoot SL

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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JOSEP OLIVA-OCHOA, MSC

Role: PRINCIPAL_INVESTIGATOR

CeraRoot SL

Locations

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CeraRoot CLINIC

Les Franqueses del Vallès, Barcelona, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 21806681 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22519944 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22335358 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23748325 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24112624 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27217032 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20369093 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37083912 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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200806

Identifier Type: -

Identifier Source: org_study_id