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

NCT ID: NCT04374201

Last Updated: 2020-05-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 37 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-11-01
• Study Completion Date: 2025-12-31

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

Conditions

Prosthesis Survival

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

2 zirconia FDPs

11 patients received 2 zirconia fixed dental prostheses

2 zirconia FDPs

Intervention Type: OTHER

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

1 zirconia FDP

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• 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

• 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 68 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Fernando Zarone

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

3Y-TZP Federico II

Identifier Type: -

Identifier Source: org_study_id