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

Active, not recruiting

• Conditions: Prosthesis Survival
• Interventions: Other: 1 zirconia FDP; Other: 2 zirconia FDPs

• Registration Number: NCT04374201
• Lead Sponsor: Federico II University

Brief Summary

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

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 Timeline

• Study Start: 2004-11-01
• Primary Completion: 2019-12-31
• Study First Submitted: 2020-04-24
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-01
• Last Update Submitted: 2020-05-01
• Study First Posted: 2020-05-05
• Last Update Posted: 2020-05-05
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 37

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1 zirconia FDP	1 zirconia FDP	26 patients received 1 zirconia FDP
2 zirconia FDPs	2 zirconia FDPs	11 patients received 2 zirconia fixed dental prostheses

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Technical and aesthetic outcomes	14 years	The United States Public Health Service criteria were used in order to examine technical and esthetic outcomes.