PMCF Study of CeraRoot Ceramic Implants One-piece: 3 Years Follow up
Post Market Clinical Follow up Study of CeraRoot Ceramic Implants One-piece: 3 Years Follow up
Post Market Clinical Follow up Study of CeraRoot Ceramic Implants One-piece: 3 Years Follow up
Sponsor study identifier
observational
98
1 country
1
Study Start
August 27, 2020
Actual (reported)Primary Completion
December 4, 2023
Actual (reported)Study Completion
December 31, 2023
Actual (reported)The main objective is to evaluate the success / failure rate of CeraRoot ceramic implants (one piece) during three year follow up.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 27, 2020
Actual (reported)September 13, 2020
Actual (reported)October 22, 2020
Actual (reported)December 4, 2023
Actual (reported)December 31, 2023
Actual (reported)December 6, 2024
Actual (reported)Number of Implants That Survived
Implant without pain, without mobility and in function.
Baseline to 3 years
Number of Implants With Surgical Complications (SC)
Baseline to 7 days
Number of Implants With Before Loading Implants Complications (BLIC)
7 days post operative to delivery of prosthesis
Number of Implants With After Loading Implants Complications (ALIC)
From delivery of prosthesis to two years later.
Number of Units With Prosthetic Complications (PC)
Baseline to 3 years
Patients that needed a tooth replacement that fulfilled the eligibility criteria.
CeraRoot CLINIC
Les Franqueses del Vallès, Barcelona, 08520, Spain
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.
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.
JOSEP OLIVA-OCHOA, MSC
CeraRoot SL
98 participants (actual enrollment reported by the registry).
First Submitted
September 13, 2020
First Posted
October 22, 2020
Study Start
August 27, 2020
Actual (reported)Hard and Soft Tissue Maintenance Around Implants With a Sloped Configuration
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
Primary Completion
December 4, 2023
Actual (reported)Study Completion
December 31, 2023
Actual (reported)Last Updated
December 6, 2024
Results First Posted
December 6, 2024
Record last verified: 2024-10
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Source: ClinicalTrials.gov.
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