Clinical Evaluation of Resin Matrix Ceramic Posterior Crowns

Dental Materials Clinical Trial

Official title:

Clinical Evaluation of Resin Matrix Ceramic and Zirconia Posterior Crowns

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05707780
• Other study ID #: UCM
• Secondary ID: 4195120
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2023
• Est. completion date: October 30, 2026

Study information

• Verified date: January 2023
• Source: Universidad Complutense de Madrid
• Contact: MARIA JESUS SUAREZ, PhD
• Phone: 0034 913942029
• Email: mjsuarez[@]ucm.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 30, 2026
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Materials

Intervention

Procedure:
• Resin-matrix
posterior crowns
• Monolithic zirconia
posterior crowns
• Metal-ceramic
posterior crowns

Locations

Country	Name	City	State
Spain	Faculty of Odontology	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid	BEGO GmbH

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival and success rates	Survival and success rates with Kaplan Meier method	3 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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