Clinical Performance of 3-Unit FPDs

NCT00223431 | Completed Phase 2

• 1 other identifier: 114-1998
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. 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. 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. 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.

Conditions

Partial Edentulism

Outcome Measures

Primary Outcomes (3)

• clinical performance

• improved esthetics

• improved occlusal function of a lithia disilicate based core ceramic. Performance was measured yearly for 4 years.

Secondary Outcomes (1)

• wear of opposing enamel

Interventions

all-ceramic fixed partial denture DEVICE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• individuals with medical contraindications to dental treatment
• parafunctional habits
• inability to ensure residence in the area for the next five years

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Ivoclar Vivadent AG: collaborator

Study Sites (1)

University of Florida College of Dentistry

Gainesville, Florida, 32610, United States

Location

Related Publications (2)

• Esquivel-Upshaw JF, Anusavice KJ, Young H, Jones J, Gibbs C. Clinical performance of a lithia disilicate-based core ceramic for three-unit posterior FPDs. Int J Prosthodont. 2004 Jul-Aug;17(4):469-75.

  PMID: 15382785 RESULT

• Gibbs CH, Anusavice KJ, Young HM, Jones JS, Esquivel-Upshaw JF. Maximum clenching force of patients with moderate loss of posterior tooth support: a pilot study. J Prosthet Dent. 2002 Nov;88(5):498-502. doi: 10.1067/mpr.2002.129062.

  PMID: 12473999 RESULT

Study Officials

• Kenneth J Anusavice, PhD, DMD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: February 1, 1998
• Study Completion: May 1, 2004
• Last Updated: September 22, 2005

Record last verified: 2005-09

Locations

US (1)