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

NCT04598776 | Completed Results

• 1 other identifier: 200806
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tooth Loss; Ceramic Implant

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Implants That Survived

  Implant without pain, without mobility and in function.

  Baseline to 3 years

Secondary Outcomes (4)

• 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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients that needed a tooth replacement that fulfilled the eligibility criteria.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CeraRoot SL: lead

Study Sites (1)

CeraRoot CLINIC

Les Franqueses del Vallès, Barcelona, 08520, Spain

Location

Related Publications (8)

• 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.

  PMID: 21806681 BACKGROUND

• 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.

  PMID: 22519944 BACKGROUND

• 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.

  PMID: 22335358 BACKGROUND

• 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.

  PMID: 23748325 BACKGROUND

• 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.

  PMID: 24112624 BACKGROUND

• 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.

  PMID: 27217032 BACKGROUND

• 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.

  PMID: 20369093 BACKGROUND

• 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.

  PMID: 37083912 BACKGROUND

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Results Point of Contact

• Title: Dr. Josep Oliva-Ochoa. Director of Clinical Trials
• Organization: CeraRoot CLINIC

josep.oliva@cerarootclinic.com

+34 935950247

Study Officials

• JOSEP OLIVA-OCHOA, MSC

  CeraRoot SL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2020
• First Posted: October 22, 2020
• Study Start: August 27, 2020
• Primary Completion: December 4, 2023
• Study Completion: December 31, 2023
• Last Updated: December 6, 2024
• Results First Posted: December 6, 2024

Record last verified: 2024-10

Locations

ES (1)