Clinical Evaluation of Resin Matrix Ceramic Posterior Crowns

Clinical Evaluation of Resin Matrix Ceramic and Zirconia Posterior Crowns

The objectives of the present prospective randomized clinical study are to evaluate and to compare the survival and success rates, possible biological and technical complications, and the clinical performance of metal-ceramic, monolithic zirconia and resin-matrix posterior crowns.

The null hypothesis is that no differences would be found between the parameters studied for each type of restoration.

Study Overview

• Status: Recruiting
• Conditions: Dental Materials
• Intervention / Treatment: Procedure: Monolithic zirconia; Procedure: Metal-ceramic; Procedure: Resin-matrix

Detailed Description

A total of 60 patients, in whom the placement of a crown in the posterior region of the maxilla or mandible was indicated, will be included in the study. The patients will be recruited from the Master of Buccofacial Prostheses and Occlusion (School of Dentistry; University Complutense of Madrid). Prior to treatment, patients will be informed regarding the aims of the study, the clinical procedure, the materials used, the risks and benefits of ceramic restorations and the alternatives to the proposed treatment. All the patients will be provided with a written informed consent for the inclusion in this study, Ninety posterior crowns will be produced and assigned in parallel and randomly to either resin-matrix ceramic, zirconia or metal-ceramic restorations. Three experienced prosthodontists will treat the patients. Abutment preparation will be performed in a standardized manner: circumferentially chamfer (1 mm in width), axial reduction of 1 mm, and an occlusal reduction of 1.5 to 2 mm. The tapering angle between the axial walls will be approximately 10- to 12- degrees. Full-arch digital impressions will be taken using an Intraoral Scanner. The restorations will be cemented with a resin cement. The restorations will be examined at one week (baseline), 1, 2, and 3 years, by two researchers who were not involved in the restorative treatment

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

Contacts and Locations

• Study Contact: Name: MARIA JESUS SUAREZ, PhD; Phone Number: 0034 913942029; Email: mjsuarez@ucm.es
• Study Contact Backup: Name: JESUS PELAEZ, PhD; Phone Number: 0034 913942029; Email: jpelaezr@ucm.es

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Recruiting
    • Faculty of Odontology
    • Contact: MARIA JESUS SUAREZ, PhD; Phone Number: 0034 913942029; Email: mjsuarez@ucm.es
    • Contact: JESUS PELAEZ, PhD; Phone Number: 0034 913942029; Email: jpelaezr@ucm.es
    • Sub-Investigator: BENJAMIN SERRANO, PhD
    • Sub-Investigator: ESTHER GONZALO, PhD
    • Sub-Investigator: CARLOS LOPEZ-SUAREZ, PhD
    • Sub-Investigator: VERONICA RODRIGUEZ, PhD
    • Sub-Investigator: CELIA TOBAR, PhD
    • Sub-Investigator: JORGE ARELLANO, Bachelor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• One posterior tooth (molar or premolar) to be crowned,
• Vital abutments or abutments with sufficient endodontic treatment
• Abutment not crowned previously
• Periodontally healthy abutments with no signs of bone resorption or periapical disease --
• Adequate occlusogingival height
• Stable occlusion, and the presence of natural dentition in the antagonist arch.

Exclusion Criteria:

• Patients who present reduced crown length (less than 3 mm occlusogingival height
• Poor oral hygiene, high caries activity, active periodontal disease or bruxism.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Resin-matrix ceramic; To assess the survival and clinical performance of resin-matrix posterior crows in a complete digital flow	Procedure: Resin-matrix; posterior crowns; Other Names: VarseoSmile crown
ACTIVE_COMPARATOR: Monolithic zirconia; To assess the survival and clinical performance of monolithic zirconia posterior crows in a complete digital flow	Procedure: Monolithic zirconia; posterior crowns
ACTIVE_COMPARATOR: Metal-ceramic; To assess the survival and clinical performance of metal-ceramic posterior crows in a complete digital flow	Procedure: Metal-ceramic; posterior crowns

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival and success rates	Survival and success rates with Kaplan Meier method	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of restorations at baseline	The restorations will be assessed using the California Dental Association's assessment system, for the surface and color, anatomic form, and margin integrity.	Baseline
Quality of restorations at 1 year	The restorations will be assessed using the California Dental Association's assessment system, for the surface and color, anatomic form, and margin integrity.	1 year
Quality of restorations at 2 years	The restorations will be assessed using the California Dental Association's assessment system, for the surface and color, anatomic form, and margin integrity.	2 years
Quality of restorations at 3 years	The restorations will be assessed using the California Dental Association's assessment system, for the surface and color, anatomic form, and margin integrity.	3 years
Plaque Index (PI) at baseline	Plaque Index (PI) of the abutment and control tooth will be assessed. A score of 0 to 3 will be assigned. Higher score will mean a worse outcome	Baseline
Plaque Index (PI) at 1 year	Plaque Index (PI) of the abutment and control tooth will be assessed. A score of 0 to 3 will be assigned. Higher score will mean a worse outcome	1 year
Plaque Index (PI) at 2 years	Plaque Index (PI) of the abutment and control tooth will be assessed. A score of 0 to 3 will be assigned. Higher score will mean a worse outcome	2 years
Plaque Index (PI) at 3 years	Plaque Index (PI) of the abutment and control tooth will be assessed. A score of 0 to 3 will be assigned. Higher score will mean a worse outcome	3 years
Gingival Index (GI) at baseline	Gingival Index (GI) of the abutment and control tooth will be assessed. A score of 0 to 3 will be assigned. Higher score will mean a worse outcome	Baseline
Gingival Index (GI) at 1 year	Gingival Index (GI) of the abutment and control tooth will be assessed. A score of 0 to 3 will be assigned. Higher score will mean a worse outcome	1 year
Gingival Index (GI) at 2 years	Gingival Index (GI) of the abutment and control tooth will be assessed. A score of 0 to 3 will be assigned. Higher score will mean a worse outcome	2 years
Gingival Index (GI) at 3 years	Gingival Index (GI) of the abutment and control tooth will be assessed. A score of 0 to 3 will be assigned. Higher score will mean a worse outcome	3 years
Probing depth at baseline	Probing depth of the abutment and control tooth. A score of 0 to 4 will be assigned. Higher score will mean a worse outcome	Baseline
Probing depth at 1 year	Probing depth of the abutment and control tooth. A score of 0 to 4 will be assigned. Higher score will mean a worse outcome	1 year
Probing depth at 2 years	Probing depth of the abutment and control tooth. A score of 0 to 4 will be assigned. Higher score will mean a worse outcome	2 years
Probing depth at 3 years	Probing depth of the abutment and control tooth. A score of 0 to 4 will be assigned. Higher score will mean a worse outcome	3 years
Margin stability at baseline	To assess the gingival margin stability of the abutment and control tooth throughout the evaluation period (subgingival, isogingival or supragingival)	Baseline
Margin stability at 1 year	To assess the gingival margin stability of the abutment and control tooth throughout the evaluation period (subgingival, isogingival or supragingival)	1 year
Margin stability at 2 years	To assess the gingival margin stability of the abutment and control tooth throughout the evaluation period (subgingival, isogingival or supragingival)	2 years
Margin stability at 3 years	To assess the gingival margin stability of the abutment and control tooth throughout the evaluation period (subgingival, isogingival or supragingival)	3 years
Patient satisfaction at 3 years	Subjective patient satisfaction using Visual analogue scale (VAS) ranged from 0 (worst possile result) to 10 (best possible result)	3 years

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Collaborators: BEGO GmbH
• Investigators: Principal Investigator: MARIA JESUS SUAREZ, PhD, University Complutense of Madrid; Principal Investigator: JESUS PELAEZ, PhD, University Complutense of Madrid

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 25, 2023
• Primary Completion (ANTICIPATED): July 1, 2023
• Study Completion (ANTICIPATED): October 30, 2026

Study Registration Dates

• First Submitted: January 22, 2023
• First Submitted That Met QC Criteria: January 22, 2023
• First Posted (ACTUAL): February 1, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 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; crowns; clinical evaluation; monolithic zirconia; resin matrix ceramic
• Other Study ID Numbers: UCM; 4195120 (OTHER_GRANT: BEGO GmbH)

Drug and device information, study documents

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