14y Prospective Study on Posterior Zirconia-based 3-unit FDPs

Fourteen-year Evaluation of Posterior Zirconia-based Three-unit Fixed Dental Prostheses. A Prospective Clinical Study of All Ceramic Prosthesis

The main objective of the present prospective study is to evaluate the effectiveness of posterior zirconia FDPs after 14 years of function.

Study Overview

• Status: Active, not recruiting
• Conditions: Prosthesis Survival
• Intervention / Treatment: Other: 2 zirconia FDPs; Other: 1 zirconia FDP

Detailed Description

thirty-seven patients needing to replace either premolars or molars were involved and 48 3-unit zirconia-based FDPs were fabricated. Patients included in the present clinical study met specific inclusion criteria and clinical procedures were standardized.

Frameworks with a 9 mm2 cross section of the connectors and 0.6 mm minimum thickness of the retainers were made by means of Computer Aided Design/Computer Assisted Manufacturing. A resin cement was used to lute the restorations. The patients were recalled after 6 and 12 months and then yearly up to a total follow-up of 14 years. The United States Public Health Service criteria were used in order to examine technical and esthetic outcomes. Success and survival rates

• Study Type: Observational
• Enrollment (Actual): 37

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

In the present prospective clinical study, 37 patients (16 males, 21 females) needing at least 1 posterior FDP in the maxillary and/or the mandibular arches were recruited. The mean age of patients was 45.3 ± 11.6 years, with a minimum age of 21 and a maximum of 68 years. All patients were recruited at the Department of Prosthodontics of the University "Federico II" of Naples (Italy) from November 2004 to April 2005 (baseline) and provided a written informed consent

Description

Inclusion Criteria:

• good general health;
• ASA I or ASA II according to the American Society of Anesthesiologists;
• good periodontal health;
• Angle class I occlusal relationship;
• minimum of 20 teeth;
• good oral hygiene;
• no evident signs of occlusal parafunctions and/or temporo-mandibular disorders.

Moreover, the abutment teeth had to fulfill the following inclusion criteria:

• periodontal health (absence of tooth mobility, absence of furcation involvement);
• proper positioning in the dental arch (tooth axes adequate for a FDP);
• sufficient occlusal-cervical height of the clinical crown (≥4 mm) for the retention of a FDP;
• vital or endodontically treated to a clinically sound state;
• opposing natural teeth or fixed prostheses.

Exclusion Criteria:- subjects preferring implant-supported prostheses;

• high caries activity;
• occlusal-gingival height of the abutment teeth <4 mm;
• reduced interocclusal distance or supraerupted opposing teeth;
• unfavorable crown-to-root ratio;
• severe wear facets, clenching, bruxism;
• presence of removable partial dentures;
• pregnancy or lactation.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
2 zirconia FDPs; 11 patients received 2 zirconia fixed dental prostheses	Other: 2 zirconia FDPs; The United States Public Health Service criteria were used in order to examine technical and esthetic outcomes. Success and survival rates of the zirconia FDPs were calculated. The biological examination was performed analyzing both abutments and contralateral teeth.
1 zirconia FDP; 26 patients received 1 zirconia FDP	Other: 1 zirconia FDP; The United States Public Health Service criteria were used in order to examine technical and esthetic outcomes. Success and survival rates of the zirconia FDPs were calculated. The biological examination was performed analyzing both abutments and contralateral teeth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival and success rate of zirconia FDPs	The 14-year cumulative survival rate of the zirconia FDPs was calculated by means of Kaplan-Meier analysis.	14 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical and aesthetic outcomes	The United States Public Health Service criteria were used in order to examine technical and esthetic outcomes.	14 years

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2004
• Primary Completion (Actual): December 31, 2019
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: May 1, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Actual): May 5, 2020
• Last Update Submitted That Met QC Criteria: May 1, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: prosthodontics; zirconia; all ceramic prosthesis; fixed dental prosthesis; prosthetic dentistry; prospective clinical study
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Prosthesis Failure
• Other Study ID Numbers: 3Y-TZP Federico II

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No