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

Prosthesis Survival Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04374201
• Other study ID #: 3Y-TZP Federico II
• Status: Active, not recruiting
• Start date: November 1, 2004
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2020
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 37
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 68 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prosthesis Failure
• Prosthesis Survival

Intervention

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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Technical and aesthetic outcomes	The United States Public Health Service criteria were used in order to examine technical and esthetic outcomes.	14 years