Clinical Evaluation of Resin Matrix Ceramic Posterior Crowns
- Conditions
- Dental Materials
- Interventions
- Procedure: Metal-ceramicProcedure: Resin-matrixProcedure: Monolithic zirconia
- Registration Number
- NCT05707780
- Lead Sponsor
- Universidad Complutense de Madrid
- Brief 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.
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- 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.
- Patients who present reduced crown length (less than 3 mm occlusogingival height
- Poor oral hygiene, high caries activity, active periodontal disease or bruxism.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Metal-ceramic Metal-ceramic To assess the survival and clinical performance of metal-ceramic posterior crows in a complete digital flow Resin-matrix ceramic Resin-matrix To assess the survival and clinical performance of resin-matrix posterior crows in a complete digital flow Monolithic zirconia Monolithic zirconia To assess the survival and clinical performance of monolithic zirconia posterior crows in a complete digital flow
- Primary Outcome Measures
Name Time Method Survival and success rates 3 years Survival and success rates with Kaplan Meier method
- Secondary Outcome Measures
Name Time Method Quality of restorations at 1 year 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.
Plaque Index (PI) at 2 years 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
Quality of restorations at 3 years 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.
Plaque Index (PI) at 1 year 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
Probing depth at 1 year 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
Margin stability at 3 years 3 years To assess the gingival margin stability of the abutment and control tooth throughout the evaluation period (subgingival, isogingival or supragingival)
Quality of restorations at baseline Baseline The restorations will be assessed using the California Dental Association's assessment system, for the surface and color, anatomic form, and margin integrity.
Plaque Index (PI) at baseline 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
Probing depth at 3 years 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
Quality of restorations at 2 years 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.
Gingival Index (GI) at 1 year 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
Gingival Index (GI) at 2 years 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
Probing depth at 2 years 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
Patient satisfaction at 3 years 3 years Subjective patient satisfaction using Visual analogue scale (VAS) ranged from 0 (worst possile result) to 10 (best possible result)
Probing depth at baseline 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
Plaque Index (PI) at 3 years 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
Gingival Index (GI) at baseline 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
Gingival Index (GI) at 3 years 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
Margin stability at baseline Baseline To assess the gingival margin stability of the abutment and control tooth throughout the evaluation period (subgingival, isogingival or supragingival)
Margin stability at 1 year 1 year To assess the gingival margin stability of the abutment and control tooth throughout the evaluation period (subgingival, isogingival or supragingival)
Margin stability at 2 years 2 years To assess the gingival margin stability of the abutment and control tooth throughout the evaluation period (subgingival, isogingival or supragingival)
Trial Locations
- Locations (1)
Faculty of Odontology
🇪🇸Madrid, Spain