Clinical trial NCT04598776: PMCF Study of CeraRoot Ceramic Implants One-piece: 3 Years Follow up
Official title: Post Market Clinical Follow up Study of CeraRoot Ceramic Implants One-piece: 3 Years Follow up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tooth Loss
Ceramic Implant
Keywords: zirconia implant
zirconium oxide implant
dental implant
ceramic implant
CeraRoot
one-piece
monotype
Lead sponsor: CeraRoot SL
Sponsor class: INDUSTRY
First posted: 2020-10-22
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that needed a tooth replacement that fulfilled the eligibility criteria.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Implants That Survived
timeFrame: Baseline to 3 years
Secondary outcomes:
measure: Number of Implants With Surgical Complications (SC)
timeFrame: Baseline to 7 days
measure: Number of Implants With Before Loading Implants Complications (BLIC)
timeFrame: 7 days post operative to delivery of prosthesis
measure: Number of Implants With After Loading Implants Complications (ALIC)
timeFrame: From delivery of prosthesis to two years later.
measure: Number of Units With Prosthetic Complications (PC)
timeFrame: Baseline to 3 years
Other outcomes:
Locations:
city: Les Franqueses del Vallès
country: Spain
facility: CeraRoot CLINIC
state: Barcelona
Study officials:
affiliation: CeraRoot SL
name: JOSEP OLIVA-OCHOA, MSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.