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

NCT04374201 | Unknown DMC

• 1 other identifier: 3Y-TZP Federico II
• Study Type: observational
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Prosthesis Survival

Keywords

zirconia; all ceramic prosthesis; prosthodontics; fixed dental prosthesis; prosthetic dentistry; prospective clinical study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Technical and aesthetic outcomes

  14 years

Study Arms (2)

2 zirconia FDPs

11 patients received 2 zirconia fixed dental prostheses

Other: 2 zirconia FDPs

1 zirconia FDP

26 patients received 1 zirconia FDP

Other: 1 zirconia FDP

Interventions

2 zirconia FDPs 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.

2 zirconia FDPs

1 zirconia FDP 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

Eligibility Criteria

• Age: 21 Years - 68 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federico II University: lead

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: May 5, 2020
• Study Start: November 1, 2004
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2025
• Last Updated: May 5, 2020

Record last verified: 2020-05