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Clinical Performance of 3-Unit FPDs

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. Identifier: NCT00223431
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : September 22, 2005
Ivoclar Vivadent AG
Information provided by:
The University of Texas Health Science Center at San Antonio

Brief Summary:

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 or disease Intervention/treatment Phase
Partial Edentulism Device: all-ceramic fixed partial denture Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Performance of Three-Unit Fixed Partial Dentures (FPDs) Made From a Hot-Pressed Ceramic (Five-Year Study)
Study Start Date : February 1998
Study Completion Date : May 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dentures

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

Secondary Outcome Measures :
  1. wear of opposing enamel

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00223431

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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 AG
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Principal Investigator: Kenneth J Anusavice, PhD, DMD University of Florida
Publications of Results:
Layout table for additonal information Identifier: NCT00223431    
Other Study ID Numbers: 114-1998
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 22, 2005
Last Verified: September 2005