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CompletedNCT02220764Updated Mar 24, 2015Results posted

Zirconia Based Fixed Dental Prostheses

An interventional study of Teeth abutment and Implant abutments in Zirconia Based Fixed Dental Prostheses, sponsored by Technische Universität Dresden. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-24.

Sponsored by Technische Universität Dresden · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

The study aims to provide evidence regarding the clinical behaviour of long-span tooth- and implant-supported FDPs.

02

Conditions studied

  • Zirconia Based Fixed Dental Prostheses

Keywords

  • prospective study
  • chipping
  • survival rate
  • fracture resistance
  • zirconia
03

In context

Lead sponsor

Technische Universität Dresden is the lead sponsor of 237 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Addiction to alcohol or drugs
  • Severe craniomandibular disorders
  • Severe systematic diseases
  • Patients unable or unwilling to sign the informed consent form
  • Untreated periodontitis
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Tooth-supported

    Long-span tooth-supported zirconia based fixed dental prostheses

    Device: Teeth abutment

  • Active comparator
    Implant-supported

    Long-span implant-supported zirconia based fixed dental prostheses

    Device: Implant abutments

Interventions

  • DeviceTeeth abutment

    Also known as: Zenotec system

  • DeviceImplant abutments

    Also known as: Zenotec system, Wital (Implant system)

06

What researchers measure

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.

    Time frame: 3 years

Secondary outcomes

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

    Measurement of the amount of fractures of the veneering material 6,12,18,24,30 and 36 months after placement of the restorations. The percentage of chips for the implant- and tooth- supported restorations will be reported.

    Time frame: 3 years

Other outcomes

  1. Number of of Fixed Dental Prostheses (FDPs) With Rough Surface

    Measurement of the restorations with rough surface 6,12,18,24,30 and 36 months after placement of the restorations.

    Time frame: 3 years

07

Results

Posted Mar 24, 2015

Participant flow

Participant flow — Overall Study
MilestoneTooth-supportedImplant-supported
Started248
Completed207
Not completed41
Withdrew: Lost to follow-up31
Withdrew: Death10

Outcome measures

PrimaryNumber 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.

Time frame:
3 years
Reported as:
Number · FDPs with failure
Number of Fixed Dental Prostheses (FDPs) With Failure
FDPs with failureTooth-supportedImplant-supported
Number of Fixed Dental Prostheses (FDPs) With Failure01
SecondaryNumber of Fixed Dental Prostheses (FDPs) With Chip/s

Measurement of the amount of fractures of the veneering material 6,12,18,24,30 and 36 months after placement of the restorations. The percentage of chips for the implant- and tooth- supported restorations will be reported.

Time frame:
3 years
Reported as:
Number · FDPs with chip/s
Number of Fixed Dental Prostheses (FDPs) With Chip/s
FDPs with chip/sTooth-supportedImplant-supported
Number of Fixed Dental Prostheses (FDPs) With Chip/s35
Statistical analysis
  • Tooth-supported vs Implant-supported · Log Rank · p = 0.03
Other pre-specifiedNumber of of Fixed Dental Prostheses (FDPs) With Rough Surface

Measurement of the restorations with rough surface 6,12,18,24,30 and 36 months after placement of the restorations.

Time frame:
3 years
Reported as:
Number · FDPs with rough surface
Number of of Fixed Dental Prostheses (FDPs) With Rough Surface
FDPs with rough surfaceTooth-supportedImplant-supported
Number of of Fixed Dental Prostheses (FDPs) With Rough Surface137

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Tooth-supported—0/24 (0%)0/24 (0%)
Implant-supported—0/8 (0%)0/8 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Tooth-supportedImplant-supportedTotal
Mean56.2 ± 9.0153.9 ± 10.954.9 ± 9.4
Sex: Female, Male
Sex: Female, Male(Participants)Tooth-supportedImplant-supportedTotal
Female11415
Male13417
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • 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. PubMed 25446240 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02220764
Lead sponsor
Technische Universität Dresden
Responsible party
Sponsor
First posted
Aug 20, 2014
Start date
May 2008
Primary completion
Nov 2013
Completion
Dec 2013
Results posted
Mar 24, 2015
Last update
Mar 24, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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