PMCF Study of CeraRoot Ceramic Implants One-piece: 1year, 5 Years Follow up

Tooth Loss Clinical Trial

Official title:

Post Market Clinical Follow up Study of CeraRoot Ceramic Implants One-piece: One Year and Five Years Follow up

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04598776
• Other study ID #: 200806
• Status: Recruiting
• Start date: August 27, 2020
• Est. completion date: August 27, 2026

Study information

• Verified date: April 2022
• Source: CeraRoot SL
• Contact: JOSE OLIVA, MSc
• Phone: (+34) 935 950 247
• Email: josep.oliva[@]cerarootclinic.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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 5 year period is needed to achieve relevant data.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 27, 2026
• Est. primary completion date: August 27, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Ceramic Implant
• Tooth Loss

Locations

Country	Name	City	State
Spain	CeraRoot CLINIC	Les Franqueses del Vallès	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
CeraRoot SL

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant survival	Implant without pain, without mobility and in function.	Baseline to 5 years
Secondary	Surgical complications (SC)	Any complications, as bleeding, infection, no primary stability, early loss.... that may appear will be collected	Baseline to 7 days
Secondary	Before loading implants Complications (BLIC)	Any complications before the prosthesis is delivered (implant mobility, implant infection, implant loss...) will be collected	7 days post operative to delivery of prosthesis
Secondary	After loading implants Complications (ALIC)	Any complications after the prosthesis is delivered (implant loss, bone loss, implant mobility...) that may appear will be recorded.	Baseline to 5 years
Secondary	Prosthetic Complications (PC)	Any difficulty during the confection of the crown, complications as decementation, chipping, etc... will be registered.	Baseline to 5 years
Secondary	Implant Success	Implant survival in addition to not having bone loss around it.	Baseline to 5 years