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A 5-year clinical study on the performance of 8 mm zirconia one-piece implants restored with three restoration materials differing in the elastic modulus

Organizational Data

DRKS-ID:
DRKS00011146
Recruitment Status:
Recruiting complete, study continuing
Date of registration in DRKS:
2016-11-15
Last update in DRKS:
2023-12-06
Registration type:
Prospective

Acronym/abbreviation of the study

ZrO2 8 mm

URL of the study

No Entry

Brief summary in lay language

Dental implants are a predictable treatment option for the replacement of single or multiple missing teeth. Titanium is considered as gold standard and the material of choice for dental implants due to its characteristics. Zirconia implants are an alternative to titanium implants. Furthermore zirconia implants overcome the esthetic problems associated with the dark grey color of titanium implants. In addition the demand for metal-free restorations from the patient's side is generally increasing. The first aim of this study is to investigate the ceramic implant. Furthermore, one out of three different materials will be randomly chosen for the final reconstruction. The second aim of the study is to compare these three different materials of the crown.

Brief summary in scientific language

Dental implants are a predictable treatment option for the replacement of single or multiple missing teeth. Titanium is considered as gold standard and the material of choice for dental implants due to its osseointegrative potential. Zirconia implants are an alternative to titanium implants as zirconia is chemically inert and therefore highly biocompatible. Furthermore zirconia implants overcome the esthetic problems associated with the dark grey color of titanium implants. In addition the demand for metal-free restorations from the patient's side is generally increasing. For titanium implants there is strong evidence that short implants (<10 mm) - which offer the benefit of less invasive surgery - are equally successful as longer implants. For zirconia implants with a length of 8 mm 1-year clinical data are encouraging. Veneered zirconia crowns on zirconia implants showed an increased chipping rate of the veneering ceramic. To avoid that failure monolithic zirconia without any veneering may be used. Furthermore, polymer infiltrated ceramic or polymer material, both with low elastic moduli may be used.

Health condition or problem studied

ICD10:
K08.1 - Loss of teeth due to accident, extraction or local periodontal disease
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Zirconia implants (ceramic.implant, VITA). Prosthetic reconstruction: monolithic zirconia (VITA YZ)
Arm 2:
Zirconia implants (ceramic.implant, VITA). Prosthetic reconstruction: monolithic polymer infiltrated ceramic (VITA Enamic)
Arm 3:
Zirconia implants (ceramic.implant, VITA). Prosthetic reconstruction: monolithic polymer (VITA CAD-Temp)

Endpoints

Primary outcome:
Mean marginal bone level after 5 years, measured by standardized digital periapical radiographs.
Secondary outcome:
Implant survival and biological complications (mucositis, periimplantits) as well as survival rate and technical complications of the three reconstruction materials, assessed after 1, 3 and 5 years

Study Design

Purpose:
Treatment
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study continuing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Switzerland
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Zentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin Zürich

Recruitment period and number of participants

Planned study start date:
2016-11-21
Actual study start date:
2016-11-22
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
45
Final Sample Size:
47

Inclusion Criteria

Sex:
All
Minimum Age:
20 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
•Male and female patients at least 20 years old, in need of an implant supported single tooth restoration •No general medical condition which represents a contraindication to implant treatment •One missing tooth in the mandible or maxilla in position of premolars or molars •At least 10 mm of vertical bone height in the mandible allowing for the placement of a 8 mm implant (2 mm safety distance to inferior alveolar nerve) •At least 7 mm of vertical bone height in the maxilla allowing for a 1 mm internal sinus elevation procedure (Osteotome technique). •Signed informed consent form

Exclusion Criteria

•Smoking of more than 15 cigarettes a day (clinical studies show an increased failure rate of implants in heavy smokers) •Poor oral hygiene after hygienic phase (Plaque Index over 30%) •Active periodontal disease •Women who are pregnant or breast feeding at the date of inclusion •Known or suspected non-compliance, drug or alcohol abuse •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant

Addresses

Primary Sponsor

Zentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin, Universität Zürich
Prof. Ronald Jung
Plattenstrasse 11
8032 Zürich
Switzerland
Telephone:
+41 44 634 04 04
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Zentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin, Universität Zürich
Prof. Ronald Jung
Plattenstrasse 11
8032 Zürich
Switzerland
Telephone:
+41 44 634 04 04
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Zentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin, Universität Zürich
Prof. Ronald Jung
Plattenstrasse 11
8032 Zürich
Switzerland
Telephone:
+41 44 634 04 04
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Zentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin, Universität Zürich
Prof. Ronald Jung
Plattenstrasse 11
8032 Zürich
Switzerland
Telephone:
+41 44 634 04 04
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Commercial (pharmaceutical industry, medical engineering industry, etc.)

VITA Zahnfabrik
79713 Bad Säckingen
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Kantonale Ethikkommission Zürich
Stampfenbachstrasse 121
8090 Zürich
Switzerland
Telephone:
(+41)43-2597970
Fax:
No Entry
Contact per E-Mail
URL:
http://www.zh.ch/kek

Vote of leading Ethics Committee

Date of ethics committee application:
2016-06-13
Ethics committee number:
2016-00955
Vote of the Ethics Committee:
Approved
Date of the vote:
2016-09-28

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry