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Clinical Performance of 3-Unit FPDs
This study has been completed.
Sponsors and Collaborators: The University of Texas Health Science Center at San Antonio
Ivoclar Vivadent
Information provided by: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00223431
  Purpose

Objectives: The purpose of this research was to determine the clinical success rate of a lithia-disilicate-based core ceramic (Ivoclar, Vivadent Corp.) for use in posterior fixed partial dentures (FPDs) as a function of bite force, cement type, connector height, and connector width.

Methods: Thirty ceramic FPD core frameworks were prepared using a hot-pressing technique and a lithia-disilicate-based core ceramic. The maximum clenching force was measured for each patient prior to tooth preparation. Connector heights and widths were measured for each FPD. Patients were recalled yearly after cementation for two years and evaluated using eleven clinical criteria. All FPDs were examined by two independent clinicians and rankings for each criterion were made from 1 to 4 with 4 = excellent and 1 = unacceptable.

The aims of this research were:

  1. To test the hypotheses that three-unit fixed partial dentures (FPDs) of a high-strength core ceramic will exhibit good-to-excellent clinical performance (based on 11 evaluative criteria) and that they will adequately resist fracture in posterior situations (excluding third molars) if fabricated with the minimal connector size (4 mm x 4 mm).
  2. To test the hypothesis that a reinforced glass ionomer cement (ProTec CEM, Ivoclar, Vivadent), when used to cement core ceramic crowns in posterior FPDs, will be associated with significantly less marginal quality, but similar fracture resistance of the ceramic crowns compared with the marginal quality associated with a dual cure resin cement (Variolink® II, Ivoclar Vivadent AG, Schaan, Liechtenstein).
  3. To test the hypothesis that there is no significant difference in tooth sensitivity associated with FPDs cemented with the glass ionomer cement and dual-cure resin cement.

Condition Intervention Phase
Partial Edentulism
Device: all-ceramic fixed partial denture
Phase II

MedlinePlus related topics: Dentures
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Clinical Performance of Three-Unit Fixed Partial Dentures (FPDs) Made From a Hot-Pressed Ceramic (Five-Year Study)

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • clinical performance
  • improved esthetics
  • improved occlusal function of a lithia disilicate based core ceramic. Performance was measured yearly for 4 years.

Secondary Outcome Measures:
  • wear of opposing enamel

Estimated Enrollment: 30
Study Start Date: February 1998
Estimated Study Completion Date: May 2004
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • missing posterior tooth in a quadrant (first premolars through second molars) that could be restored with a 3-unit FPD
  • periodontal pockets of less than 4 mm for each abutment with no periodontal disease
  • vital abutment teeth
  • crown root ratio of at least 1:1.

Exclusion Criteria:

  • individuals with medical contraindications to dental treatment
  • parafunctional habits
  • inability to ensure residence in the area for the next five years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00223431

Locations
United States, Florida
University of Florida College of Dentistry
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Ivoclar Vivadent
Investigators
Principal Investigator: Kenneth J Anusavice, PhD, DMD University of Florida
  More Information

Publications of Results:
Study ID Numbers: 114-1998
Study First Received: September 13, 2005
Last Updated: September 13, 2005
ClinicalTrials.gov Identifier: NCT00223431  
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on February 05, 2009