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Trial Outcomes & Findings for T-116_Procera-Bridge Zirconia - A Clinical Study (NCT NCT02186808)

NCT ID: NCT02186808

Last Updated: 2016-10-27

Results Overview

The CDA index (1) is Romeo or Sierra at delivery and remains so up to 1 year post loading.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

80 participants

Primary outcome timeframe

prosthesis delivery, 1 year

Results posted on

2016-10-27

Participant Flow

Participant milestones

Participant milestones
Measure
Procera® Bridge Zirconia
Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible. Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.
Overall Study
STARTED
80
Overall Study
COMPLETED
67
Overall Study
NOT COMPLETED
13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

T-116_Procera-Bridge Zirconia - A Clinical Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Procera® Bridge Zirconia
n=80 Participants
Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible. Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
71 Participants
n=5 Participants
Age, Categorical
>=65 years
9 Participants
n=5 Participants
Sex: Female, Male
Female
48 Participants
n=5 Participants
Sex: Female, Male
Male
32 Participants
n=5 Participants

PRIMARY outcome

Timeframe: prosthesis delivery, 1 year

Population: 78 patients were treated in total. 4 of the patients received two bridges (which is complaint with the protocol). Therefore there are more bridges than patients.

The CDA index (1) is Romeo or Sierra at delivery and remains so up to 1 year post loading.

Outcome measures

Outcome measures
Measure
Procera® Bridge Zirconia
n=82 bridges
Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible. Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.
Success Rate of Bridge Procera Bridge Zirconia
100 percentage of successful implants

SECONDARY outcome

Timeframe: prosthesis delivery, 5 years

Population: 5 year data. Not all initially treated patients could be followed over the 5 years.

The CDA index (1) is Romeo or Sierra at delivery and remains so 5 year post loading.

Outcome measures

Outcome measures
Measure
Procera® Bridge Zirconia
n=69 Number of Bridges analyzed
Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible. Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.
Success Rate of Bridge Procera Bridge Zirconia
95.8 percentage of successful implants

Adverse Events

Procera® Bridge Zirconia

Serious events: 3 serious events
Other events: 38 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Procera® Bridge Zirconia
n=80 participants at risk
Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible. Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.
Cardiac disorders
Cardiac arrhytmia
1.2%
1/80 • Number of events 1
Cardiac disorders
Heart disease
1.2%
1/80 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
1.2%
1/80 • Number of events 1

Other adverse events

Other adverse events
Measure
Procera® Bridge Zirconia
n=80 participants at risk
Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible. Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.
Surgical and medical procedures
Porcelain fractures
27.5%
22/80 • Number of events 27
Surgical and medical procedures
occlusal adjustments
17.5%
14/80 • Number of events 15
Surgical and medical procedures
Periodontal problems
12.5%
10/80 • Number of events 10

Additional Information

Head of Clinical Trial Management

Nobel Biocare

Phone: +41 43 211 42 00

Results disclosure agreements

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