Clinical Evaluation of Resin Matrix Ceramic Posterior Crowns

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Clinical Evaluation of Resin Matrix Ceramic and Zirconia Posterior Crowns

Conditions
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Dental Materials

Intervention / Treatment
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* Procedure: Resin-matrix
* Procedure: Monolithic zirconia
* Procedure: Metal-ceramic


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resin-matrix ceramic<br>To assess the survival and clinical performance of resin-matrix posterior crows in a complete digital flow | Procedure: Resin-matrix<br>* posterior crowns<br>* Other names: VarseoSmile crown;|
| Active Comparator: Monolithic zirconia<br>To assess the survival and clinical performance of monolithic zirconia posterior crows in a complete digital flow | Procedure: Monolithic zirconia<br>* posterior crowns<br>|
| Active Comparator: Metal-ceramic<br>To assess the survival and clinical performance of metal-ceramic posterior crows in a complete digital flow | Procedure: Metal-ceramic<br>* posterior crowns<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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crowns, monolithic zirconia, resin matrix ceramic, clinical evaluation, survival