NCT02220764

Brief Summary

The objective of this prospective clinical study is to investigate the differences in the complication rates between tooth- and implant- supported zirconia based fixed dental prostheses (FDPs) with at least 4 units. The null-hypothesis is that there is no difference in the complication rates between implant- supported and tooth- supported zirconia FDPs.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2008

Longer than P75 for not_applicable

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

May 1, 2008

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 20, 2014

Completed
7 months until next milestone

Results Posted

Study results publicly available

March 24, 2015

Completed
Last Updated

March 24, 2015

Status Verified

March 1, 2015

Enrollment Period

5.5 years

First QC Date

July 16, 2014

Results QC Date

March 4, 2015

Last Update Submit

March 23, 2015

Conditions

Keywords

prospective studychippingsurvival ratefracture resistancezirconia

Outcome Measures

Primary Outcomes (1)

  • Number of Fixed Dental Prostheses (FDPs) With Failure

    "Failure" was recorded if there was a need to remove the Fixed Dental Prosthesis over the observation period.

    3 years

Secondary Outcomes (1)

  • Number of Fixed Dental Prostheses (FDPs) With Chip/s

    3 years

Other Outcomes (1)

  • Number of of Fixed Dental Prostheses (FDPs) With Rough Surface

    3 years

Study Arms (2)

Tooth-supported

EXPERIMENTAL

Long-span tooth-supported zirconia based fixed dental prostheses

Device: Teeth abutment

Implant-supported

ACTIVE COMPARATOR

Long-span implant-supported zirconia based fixed dental prostheses

Device: Implant abutments

Interventions

Also known as: Zenotec system
Tooth-supported
Also known as: Zenotec system, Wital (Implant system)
Implant-supported

Eligibility Criteria

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

You may qualify if:

  • Patients older than 18 years
  • Missing of at least two adjacent teeth in the maxilla or mandibular
  • Sufficient oral hygiene

You may not qualify if:

  • Addiction to alcohol or drugs
  • Severe craniomandibular disorders
  • Severe systematic diseases
  • Patients unable or unwilling to sign the informed consent form
  • Untreated periodontitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Konstantinidis IK, Jacoby S, Radel M, Boning K. Prospective evaluation of zirconia based tooth- and implant-supported fixed dental prostheses: 3-year results. J Dent. 2015 Jan;43(1):87-93. doi: 10.1016/j.jdent.2014.10.011. Epub 2014 Nov 5.

Results Point of Contact

Title
Dr. Konstantinidis Ioannis
Organization
Zahnärztliche Prothetik

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2014

First Posted

August 20, 2014

Study Start

May 1, 2008

Primary Completion

November 1, 2013

Study Completion

December 1, 2013

Last Updated

March 24, 2015

Results First Posted

March 24, 2015

Record last verified: 2015-03