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NCT00223431 · ClinicalTrials.gov registry record · Phase 2

Clinical Performance of 3-Unit FPDs

A Phase 2 study, sponsored by The University of Texas Health Science Center at San Antonio.

Completed
Registry status
Phase 2
Development phase
30
Enrollment target

NCT00223431 is a Phase 2 study that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 30 participants.

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The verdict

NCT00223431, a Phase 2 study, has completed, sponsored by The University of Texas Health Science Center at San Antonio.

COMPLETED
Registry status
Phase 2
Development phase
30 participants
Enrollment target

Study 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.

Interventions

  • DEVICE all-ceramic fixed partial denture

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 1998-02
Est. Completion 2004-05
Phase Phase 2

What the Registry Record Tells You About NCT00223431

The ClinicalTrials.gov registry entry for NCT00223431 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center at San Antonio, which has 378 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which all-ceramic fixed partial denture is the first listed.

NCT00223431 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00223431 about?

NCT00223431 is a clinical study titled "Clinical Performance of 3-Unit FPDs". 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...

What is the current status of trial NCT00223431?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 1998-02. Estimated completion is 2004-05.

What interventions are being tested in trial NCT00223431?

The interventions under investigation include: all-ceramic fixed partial denture (DEVICE).

Who is sponsoring clinical trial NCT00223431?

This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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