Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Zirconia Based Fixed Dental Prostheses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02220764
Recruitment Status : Completed
First Posted : August 20, 2014
Results First Posted : March 24, 2015
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
Technische Universität Dresden

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Zirconia Based Fixed Dental Prostheses
Interventions Device: Teeth abutment
Device: Implant abutments
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tooth-supported Implant-supported
Hide Arm/Group Description

Long-span tooth-supported zirconia based fixed dental prostheses

Teeth abutment

Long-span implant-supported zirconia based fixed dental prostheses

Implant abutments

Period Title: Overall Study
Started 24 8
Completed 20 7
Not Completed 4 1
Reason Not Completed
Lost to Follow-up             3             1
Death             1             0
Arm/Group Title Tooth-supported Implant-supported Total
Hide Arm/Group Description

Long-span tooth-supported zirconia based fixed dental prostheses

Teeth abutment

Long-span implant-supported zirconia based fixed dental prostheses

Implant abutments

Total of all reporting groups
Overall Number of Baseline Participants 24 8 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 8 participants 32 participants
56.2  (9.01) 53.9  (10.9) 54.9  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 8 participants 32 participants
Female
11
  45.8%
4
  50.0%
15
  46.9%
Male
13
  54.2%
4
  50.0%
17
  53.1%
1.Primary Outcome
Title Number of Fixed Dental Prostheses (FDPs) With Failure
Hide Description "Failure" was recorded if there was a need to remove the Fixed Dental Prosthesis over the observation period.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tooth-supported Implant-supported
Hide Arm/Group Description:

Long-span tooth-supported zirconia based fixed dental prostheses

Teeth abutment

Long-span implant-supported zirconia based fixed dental prostheses

Implant abutments

Overall Number of Participants Analyzed 20 7
Measure Type: Number
Unit of Measure: FDPs with failure
0 1
2.Secondary Outcome
Title Number of Fixed Dental Prostheses (FDPs) With Chip/s
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tooth-supported Implant-supported
Hide Arm/Group Description:

Long-span tooth-supported zirconia based fixed dental prostheses

Teeth abutment

Long-span implant-supported zirconia based fixed dental prostheses

Implant abutments

Overall Number of Participants Analyzed 20 7
Measure Type: Number
Unit of Measure: FDPs with chip/s
3 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tooth-supported, Implant-supported
Comments Null hypothesis: The chipping rates between tooth- and implant- supoorted FDPs are equally distributed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
3.Other Pre-specified Outcome
Title Number of of Fixed Dental Prostheses (FDPs) With Rough Surface
Hide Description Measurement of the restorations with rough surface 6,12,18,24,30 and 36 months after placement of the restorations.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tooth-supported Implant-supported
Hide Arm/Group Description:

Long-span tooth-supported zirconia based fixed dental prostheses

Teeth abutment

Long-span implant-supported zirconia based fixed dental prostheses

Implant abutments

Overall Number of Participants Analyzed 20 7
Measure Type: Number
Unit of Measure: FDPs with rough surface
13 7
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tooth-supported Implant-supported
Hide Arm/Group Description

Long-span tooth-supported zirconia based fixed dental prostheses

Teeth abutment

Long-span implant-supported zirconia based fixed dental prostheses

Implant abutments

All-Cause Mortality
Tooth-supported Implant-supported
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tooth-supported Implant-supported
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tooth-supported Implant-supported
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/8 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Konstantinidis Ioannis
Organization: Zahnärztliche Prothetik
Phone: +49 351 458 4231
Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT02220764     History of Changes
Other Study ID Numbers: W-008
First Submitted: July 16, 2014
First Posted: August 20, 2014
Results First Submitted: March 4, 2015
Results First Posted: March 24, 2015
Last Update Posted: March 24, 2015