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Trial record 26 of 119 for:    ZIRCONIUM

T-116_Procera-Bridge Zirconia - A Clinical Study

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ClinicalTrials.gov Identifier: NCT02186808
Recruitment Status : Completed
First Posted : July 10, 2014
Results First Posted : April 25, 2016
Last Update Posted : October 27, 2016
Sponsor:
Information provided by (Responsible Party):
Nobel Biocare

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Partial Edentulism
Intervention Device: Procera® Bridge Zirconia
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Procera® Bridge Zirconia
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 80
Completed 67
Not Completed 13
Arm/Group Title Procera® Bridge Zirconia
Hide Arm/Group Description

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 Number of Baseline Participants 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants
<=18 years
0
   0.0%
Between 18 and 65 years
71
  88.8%
>=65 years
9
  11.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants
Female
48
  60.0%
Male
32
  40.0%
1.Primary Outcome
Title Success Rate of Bridge Procera Bridge Zirconia
Hide Description The CDA index (1) is Romeo or Sierra at delivery and remains so up to 1 year post loading.
Time Frame prosthesis delivery, 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Procera® Bridge Zirconia
Hide Arm/Group Description:

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 Number of Participants Analyzed 78
Overall Number of Units Analyzed
Type of Units Analyzed: Bridges
82
Measure Type: Number
Unit of Measure: percentage of successful implants
100
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Procera® Bridge Zirconia
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Success Rate of Bridge Procera Bridge Zirconia
Hide Description The CDA index (1) is Romeo or Sierra at delivery and remains so 5 year post loading.
Time Frame prosthesis delivery, 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
5 year data. Not all initially treated patients could be followed over the 5 years.
Arm/Group Title Procera® Bridge Zirconia
Hide Arm/Group Description:

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 Number of Participants Analyzed 67
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Bridges analyzed
69
Measure Type: Number
Unit of Measure: percentage of successful implants
95.8
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Procera® Bridge Zirconia
Hide Arm/Group Description

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.

All-Cause Mortality
Procera® Bridge Zirconia
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Procera® Bridge Zirconia
Affected / at Risk (%) # Events
Total   3/80 (3.75%)    
Cardiac disorders   
Cardiac arrhytmia  [1]  1/80 (1.25%)  1
Heart disease  [1]  1/80 (1.25%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer  [1]  1/80 (1.25%)  1
Indicates events were collected by systematic assessment
[1]
Deceased, no evidence for a device related complication is reported.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Procera® Bridge Zirconia
Affected / at Risk (%) # Events
Total   38/80 (47.50%)    
Surgical and medical procedures   
Porcelain fractures   22/80 (27.50%)  27
occlusal adjustments   14/80 (17.50%)  15
Periodontal problems   10/80 (12.50%)  10
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Head of Clinical Trial Management
Organization: Nobel Biocare
Phone: +41 43 211 42 00
EMail: isabelle.arrighi@nobelbiocare.com
Publications:
Association, C.D., Quality Evaluation for Dental Care. Guidelines for the Assessment of Clinical Quality and Professional Performance. Los Angeles: CDA, 1977.
Layout table for additonal information
Responsible Party: Nobel Biocare
ClinicalTrials.gov Identifier: NCT02186808     History of Changes
Other Study ID Numbers: T-116
First Submitted: June 27, 2014
First Posted: July 10, 2014
Results First Submitted: March 23, 2016
Results First Posted: April 25, 2016
Last Update Posted: October 27, 2016