Clinical Evaluation of Monolithic Zirconia FPDs

Clinical Evaluation of Monolithic Zirconia and Metal-ceramic Posterior Fixed Partial Dentures

The objectives of the present study are to compare the survival rates and possible biological and technical complications of metal-ceramic, veneered and monolithic zirconia posterior three-unit fixed partial dentures. The null hypothesis is that no differences would be found between the parameters studied for each type of restoration.

Study Overview

• Status: Completed
• Conditions: Dental Materials
• Intervention / Treatment: Drug: Monolithic zirconia; Other: Veneered zirconia; Other: Metal-ceramic

Detailed Description

Ninety patients requiring at least one 3-unit Fixed partial denture (FPD) in the posterior region of the maxilla or mandible were included in this study. All subjects were recruited from the Master in Buccofacial Prostheses and Occlusion (Faculty of Odontology, University Complutense of Madrid, Spain). Before treatment, patients were informed of the study objectives, clinical procedures, materials used, advantages and possible risks of the ceramic material, and other therapeutic alternatives. Prior to the study, participants were asked to provide written informed consent. Ninety posterior FPDs were produced and allocated in parallel and randomly to either monolithic zirconia, veneered zirconia or MC restorations. The clinical procedures were performed by two experienced clinicians. All participants received oral hygiene instructions and a professional tooth cleaning prior to prosthetic treatment. The abutment teeth were prepared with a 0.8- to 1-mm-wide circumferential chamfer, an axial reduction of 1 mm and an occlusal reduction of 1.5- to 2.0-mm. A 10- to 15- degree angle of convergence was achieved for the axial walls. Tooth preparations were scanned with an intraoral scanner and the FPDs were designed using specific software. The restorations were then cemented using a resin self-adhesive cement. After cementation, occlusal contacts were evaluated, and the adjusted surfaces were polished using a porcelain polishing kit. The 90 FPDs were examined at 1week (baseline),1, 2 and 2 years by 2 researchers who were not involved in the restorative treatment.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• One posterior tooth (molar or premolar) to be replaced
• Vital abutments or abutments with an adequate endodontic treatment
• Abutment not crowned previously
• Periodontally healthy abutments with no signs of bone resorption or periapical disease
• Adequate occlusogingival height for an appropiate connector area of at least 9 mm2
• Stable occlusion and the presence of natural dentition in the antagonist arch.

Exclusion Criteria:

• Patients who require a Fixed Dental Prosthesis of more than three units
• Patients who present reduced crown length (less than 3 mm occlusogingival heigth)
• Poor oral hygiene, high caries activity, or active periodontal disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Monolithic zirconia; Monolithic zirconia posterior 3-unit fixed partial dentures	Drug: Monolithic zirconia; To assess the clinical performance and survival of posterior monolithic zirconia fixed partial dentures; Other Names: Zenostar T; Wieland Dental
Active Comparator: Veneered zirconia; Veneered zirconia posterior 3-unit fixed partial dentures	Other: Veneered zirconia; To assess the clinical performance and survival of posterior veneered zirconia fixed partial dentures; Other Names: IPS e.max ZirCAD
Active Comparator: Metal-ceramic; Metal-ceramic posterior 3-unit fixed partial dentures	Other: Metal-ceramic; To assess the clinical performance and survival of posterior metal-ceramic fixed partial dentures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque Index (PI) at 1 year	Plaque Index (PI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.	1 year
Plaque Index (PI) at 2 years	Plaque Index (PI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.	2 years
Plaque Index (PI) at 3 years	Plaque Index (PI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.	3 years
Gingival Index (GI) at baseline	Gingival Index (GI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.	Baseline
Gingival Index (GI) at 1 year	Gingival Index (GI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.	1 year
Gingival Index (GI) at 2 years	Gingival Index (GI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.	2 years
Gingival Index (GI) at 3 years	Gingival Index (GI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.	3 years
Margin stability at baseline	To assess the gingival margin stability throughout the evaluation period (subgingival, isogingival or supragingival)	Baseline
Margin stability at 1 year	To assess the gingival margin stability throughout the evaluation period (subgingival, isogingival or supragingival)	1 year
Margin stability at 2 years	To assess the gingival margin stability throughout the evaluation period (subgingival, isogingival or supragingival)	2 years
Margin stability at 3 years	To assess the gingival margin stability throughout the evaluation period (subgingival, isogingival or supragingival)	3 years
Probing depth at baseline	Probing depth of the abutment and control teeth. A score of 0 to 4 was assigned. Higher score means a worse outcome	Baseline
Probing depth at 1 year	Probing depth of the abutment and control teeth. A score of 0 to 4 was assigned. Higher score means a worse outcome	1 year
Probing depth at 2 years	Probing depth of the abutment and control teeth. A score of 0 to 4 was assigned. Higher score means a worse outcome	2 years
Probing depth at 3 years	Probing depth of the abutment and control teeth. A score of 0 to 4 was assigned. Higher score means a worse outcome	3 years
Patient satisfaction at 3 years	Subjective patient satisfaction using Visual analogue scale (VAS) ranged from 0 (worst possible result) to10 (best possible result). The items analyzed were: esthetics, function, comfort, overall satisfaction	3 years
Quality of restorations at baseline	The quality of the surface and color, anatomical form and marginal integrity was assessed using the California Dental Association's assessment system. Each CDA criterion was ranked on a scale of 1 to 4, where 4 = excellent, 3 = good, 2 = unacceptable (repair), and 1 = unacceptable (replacement).	Baseline
Quality of restorations at 1 year	The quality of the surface and color, anatomical form and marginal integrity was assessed using the California Dental Association's assessment system. Each CDA criterion was ranked on a scale of 1 to 4, where 4 = excellent, 3 = good, 2 = unacceptable (repair), and 1 = unacceptable (replacement).	1 year
Quality of restorations at 2 years	The quality of the surface and color, anatomical form and marginal integrity was assessed using the California Dental Association's assessment system. Each CDA criterion was ranked on a scale of 1 to 4, where 4 = excellent, 3 = good, 2 = unacceptable (repair), and 1 = unacceptable (replacement).ty was assessed	2 years
Quality of restorations at 3 years	The quality of the surface and color, anatomical form and marginal integrity was assessed using the California Dental Association's assessment system. Each CDA criterion was ranked on a scale of 1 to 4, where 4 = excellent, 3 = good, 2 = unacceptable (repair), and 1 = unacceptable (replacement).	3 years
Plaque Index (PI) at baseline	Plaque Index (PI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.	Baseline

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Collaborators: Ivoclar Vivadent AG

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2016
• Primary Completion (Actual): March 30, 2019
• Study Completion (Actual): December 12, 2022

Study Registration Dates

• First Submitted: April 15, 2021
• First Submitted That Met QC Criteria: May 7, 2021
• First Posted (Actual): May 10, 2021

Study Record Updates

• Last Update Posted (Actual): January 25, 2023
• Last Update Submitted That Met QC Criteria: January 22, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: survival; clinical evaluation; monolithic zirconia; fixed partial dentures; veneered zirconia
• Other Study ID Numbers: 4155858 Ivoclar Vivadent AG; 15/236-E (Other Identifier: Ethical Committee of Clinical Research. Hospital S. Carlos.)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No