Clinical trial NCT04374201: 14y Prospective Study on Posterior Zirconia-based 3-unit FDPs
Official title: Fourteen-year Evaluation of Posterior Zirconia-based Three-unit Fixed Dental Prostheses. A Prospective Clinical Study of All Ceramic Prosthesis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prosthesis Survival
Keywords: zirconia
all ceramic prosthesis
prosthodontics
fixed dental prosthesis
prosthetic dentistry
prospective clinical study
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 37
Sex: ALL
Minimum age (years): 21
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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

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.

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.

Primary outcomes:
measure: Survival and success rate of zirconia FDPs
timeFrame: 14 years
Secondary outcomes:
measure: Technical and aesthetic outcomes
timeFrame: 14 years
Other outcomes:
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