NCT02163395

Brief Summary

  • Straumann Monotype FullCeram implants serve as a suitable alternative for implant therapy especially in the aesthetic zone
  • The survival rate of Straumann Ceramic implants should be at least 85% (max 6 implant losses out of 40 patients) after the first year

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 16, 2015

Completed
8.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2023

Completed
Last Updated

November 22, 2023

Status Verified

May 1, 2022

Enrollment Period

1.9 years

First QC Date

June 10, 2014

Results QC Date

May 18, 2015

Last Update Submit

November 21, 2023

Conditions

Tooth Loss

Keywords

Ceramic implant

Outcome Measures

Primary Outcomes (1)

  • The Implant Survival

    A surviving implant is an integrated implant in the patient's jaw bone at the time of assessment.

    Measured at 12 months +/- 4 weeks after implant placement

Secondary Outcomes (3)

  • The Implant Success

    Measured at Week 26, Month 12, Month 24 and Month 36

  • Mean Bone Level Changes (Distal and Mesial)

    Measured at Week 26, Month 12, Month 24 and Month 36

  • The Implant Survival

    Measured at Week 26, Month 24 and Month 36

Study Arms (1)

FullCeram implant

OTHER

Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment heights of 4.0 or 5.5 mm

Device: FullCeram implant

Interventions

FullCeram implantDEVICE

FullCeram implantation

Also known as: Straumann Monotype FullCeram (Zirconium dioxide)
FullCeram implant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject must have voluntary signed the informed consent and the data protection consent form before any study related action
  • Males and females with at least 18 years of age (including 18 years)
  • Implant placement planned in the maxilla or mandible
  • The missing tooth site must have a tooth with a natural root
  • Substantially healed and augmented extraction sockets (minimal 8 weeks)
  • Autogenous bone augmentation until 3 month pre-implantation were bone deficiency jeopardizing the implant position

You may not qualify if:

  • Systemic disease that would interfere with dental implant therapy
  • Any contraindications for oral surgical procedures
  • Mucosal diseases
  • History of local irradiation therapy
  • Current untreated periodontitis or gingivitis
  • Any untreated endodontic lesions
  • Probing pocket depth of \> or = 4 mm on one of the teeth immediately adjacent to the dental implant site
  • Severe bruxing or clenching habits
  • Patients with inadequate oral hygiene or unmotivated for adequate home care
  • Patients who smoke \>10 cigarettes per day or tobacco equivalents or chew tobacco
  • Subjects who have undergone administration of any investigational device within 30 days of enrolment in the study
  • Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability
  • Physical or mental handicaps that would interfere with the ability to perform adequate oral hygiene
  • Pregnant women at screening
  • Lack of primary stability of the implant (hand testing directly after surgery)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Medizinische Hochschule Hannover Klinik und Poliklinik fuer Mund-, Kiefer- und Gesichtschirurgie

Hanover, 30625, Germany

Location

Oralchirurgie T1

Munich, 80333, Germany

Location

Katharinenhospital

Stuttgart, 70174, Germany

Location

Related Publications (2)

  • Lambrecht TJ, Filipi A, Raetzer Luenzel A, Schiel HJ. Long-Term evaluation of submerged and nonsubmerged ITI solid-screw titanium implants. A 10-year life table analysis of 468 implants. Int J Oral Maxifollofac Implants; 18:826-834, 2003. Kohal R J, et al. Loaded custom-made zirconia and titanium implants show similar osseointegration: an animal experiment. J Periodontol. 75.9, 1262-68, 2004. Scarano A, et al. Bone response to zirconia ceramic implants: an experimental study in rabbits. J Oral Implantol. 8-12, 29.1, 2003. Sennerby L, at al. Bone tissue resonses to surface-modified zirconia implants: A histomorphometric and removal torque study in the rabbit. Clin. Implant. Dent.Relat Res. 7 Suppl: S13-S20, 2005. Blaschke C, and Volz U. Soft and hard tissue response to zirconium dioxide dental implants - a clinical study in man. Neuro.Endocrinol.Lett. 27.Suppl1, 2006. Olivia J, Olivia X, Olivia JD. One year follow-up of first consecutive 100 Zirconia Dental Implants in humans: A comparison of 2 different rough surfaces. Int J Oral Maxillofac Implants; 22:430-435, 2007. Herrmann JS, Buser D, Schenk RK, Schoolfield JD, Cochran DL. Biologic width around one-and two-piece titanium implants. A histometric evaluation of unloaded nonsubmerged and submerged implants in the canine mandible. Clin Oral Impl Res 12, 559-571, 2001. Todescan FF, Pustiglioni FE, Imbronito AV, Albrektson T, Gioso M. Influenze of the microgap in the peri-implant hard and soft tissues. A histomorphometric study in dogs. Int J Pral Maxillofac Implants 17:467-472, 2002. Buser D, Weber HP, Braegger U, Balsinger C. Gewebeintegration einphasiger ITI-Implantate: Drei-Jahres-Ergebnisse einer prospektiven Langzeitstudie mit Hohlzylinder- und Hohlschraubenimplantaten. Buser D, Martin W, Belser UC. Optimizing Esthetics for Implant restorations in the Anterior Maxilla: Anatomic and Surgical Considerations. Int. J Oral and Maxillofacial Implants. Supplement; 19:43-61, 2004.

    BACKGROUND

  • Bormann KH, Gellrich NC, Kniha H, Schild S, Weingart D, Gahlert M. A prospective clinical study to evaluate the performance of zirconium dioxide dental implants in single-tooth edentulous area: 3-year follow-up. BMC Oral Health. 2018 Nov 1;18(1):181. doi: 10.1186/s12903-018-0636-x.

    PMID: 30382850DERIVED

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesTooth Diseases

Results Point of Contact

Title
Intsitut Straumann AG
Organization
Clinical Research
research@straumann.com
0041619651111

Study Officials

  • Michael Gahlert, Prof Dr Dr

    Oralchirurgie T1

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2014

First Posted

June 13, 2014

Study Start

October 1, 2011

Primary Completion

September 1, 2013

Study Completion

November 21, 2023

Last Updated

November 22, 2023

Results First Posted

July 16, 2015

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(3)