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Trial Outcomes & Findings for Zirconia Based Fixed Dental Prostheses (NCT NCT02220764)

NCT ID: NCT02220764

Last Updated: 2015-03-24

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

32 participants

Primary outcome timeframe

3 years

Results posted on

2015-03-24

Participant Flow

Participant milestones

Participant milestones
Measure
Tooth-supported
Long-span tooth-supported zirconia based fixed dental prostheses Teeth abutment
Implant-supported
Long-span implant-supported zirconia based fixed dental prostheses Implant abutments
Overall Study
STARTED
24
8
Overall Study
COMPLETED
20
7
Overall Study
NOT COMPLETED
4
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Tooth-supported
Long-span tooth-supported zirconia based fixed dental prostheses Teeth abutment
Implant-supported
Long-span implant-supported zirconia based fixed dental prostheses Implant abutments
Overall Study
Lost to Follow-up
3
1
Overall Study
Death
1
0

Baseline Characteristics

Zirconia Based Fixed Dental Prostheses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Tooth-supported
n=24 Participants
Long-span tooth-supported zirconia based fixed dental prostheses Teeth abutment
Implant-supported
n=8 Participants
Long-span implant-supported zirconia based fixed dental prostheses Implant abutments
Total
n=32 Participants
Total of all reporting groups
Age, Continuous
56.2 years
STANDARD_DEVIATION 9.01 • n=99 Participants
53.9 years
STANDARD_DEVIATION 10.9 • n=107 Participants
54.9 years
STANDARD_DEVIATION 9.4 • n=206 Participants
Sex: Female, Male
Female
11 Participants
n=99 Participants
4 Participants
n=107 Participants
15 Participants
n=206 Participants
Sex: Female, Male
Male
13 Participants
n=99 Participants
4 Participants
n=107 Participants
17 Participants
n=206 Participants

PRIMARY outcome

Timeframe: 3 years

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

Outcome measures

Outcome measures
Measure
Tooth-supported
n=20 Participants
Long-span tooth-supported zirconia based fixed dental prostheses Teeth abutment
Implant-supported
n=7 Participants
Long-span implant-supported zirconia based fixed dental prostheses Implant abutments
Number of Fixed Dental Prostheses (FDPs) With Failure
0 FDPs with failure
1 FDPs with failure

SECONDARY outcome

Timeframe: 3 years

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.

Outcome measures

Outcome measures
Measure
Tooth-supported
n=20 Participants
Long-span tooth-supported zirconia based fixed dental prostheses Teeth abutment
Implant-supported
n=7 Participants
Long-span implant-supported zirconia based fixed dental prostheses Implant abutments
Number of Fixed Dental Prostheses (FDPs) With Chip/s
3 FDPs with chip/s
5 FDPs with chip/s

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

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

Outcome measures

Outcome measures
Measure
Tooth-supported
n=20 Participants
Long-span tooth-supported zirconia based fixed dental prostheses Teeth abutment
Implant-supported
n=7 Participants
Long-span implant-supported zirconia based fixed dental prostheses Implant abutments
Number of of Fixed Dental Prostheses (FDPs) With Rough Surface
13 FDPs with rough surface
7 FDPs with rough surface

Adverse Events

Tooth-supported

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Implant-supported

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Konstantinidis Ioannis

Zahnärztliche Prothetik

Phone: +49 351 458 4231

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place