Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 4195120 | Other Grant/Funding Number | BEGO GmbH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| BEGO GmbH | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resin-matrix ceramic | Experimental | To assess the survival and clinical performance of resin-matrix posterior crows in a complete digital flow |
|
| Monolithic zirconia | Active Comparator | To assess the survival and clinical performance of monolithic zirconia posterior crows in a complete digital flow |
|
| Metal-ceramic | Active Comparator | To assess the survival and clinical performance of metal-ceramic posterior crows in a complete digital flow |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resin-matrix | Procedure | posterior crowns |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival and success rates | Survival and success rates with Kaplan Meier method | 3 years |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MARIA JESUS SUAREZ, PhD | Contact | 0034 913942029 | mjsuarez@ucm.es | |
| JESUS PELAEZ, PhD | Contact | 0034 913942029 | jpelaezr@ucm.es |
| Name | Affiliation | Role |
|---|---|---|
| MARIA JESUS SUAREZ, PhD | UNIVERSITY COMPLUTENSE OF MADRID | Principal Investigator |
| JESUS PELAEZ, PhD | UNIVERSITY COMPLUTENSE OF MADRID | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Odontology | Recruiting | Madrid | 28040 | Spain |
Not provided
| ID | Term |
|---|---|
| D016876 | Metal Ceramic Alloys |
| ID | Term |
|---|---|
| D000497 | Alloys |
| D008670 | Metals |
| D007287 | Inorganic Chemicals |
| D001697 | Biomedical and Dental Materials |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Monolithic zirconia | Procedure | posterior crowns |
|
| Metal-ceramic | Procedure | posterior crowns |
|
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 |
| D003722 |
| Dental Alloys |
| D003764 | Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |