Clinical Evaluation of Monolithic Zirconia FPDs

Universidad Complutense de Madrid

Status: Completed

Conditions: Dental Materials

Treatments: Drug: Monolithic zirconia; Other: Metal-ceramic; Other: Veneered zirconia

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04879498

15/236-E (Other Identifier)

4155858 Ivoclar Vivadent AG

Details and patient eligibility

About

The objectives of the present study are to compare the survival rates and possible biological and technical complications of metal-ceramic, veneered and monolithic zirconia posterior three-unit fixed partial dentures. The null hypothesis is that no differences would be found between the parameters studied for each type of restoration.

Full description

Ninety patients requiring at least one 3-unit Fixed partial denture (FPD) in the posterior region of the maxilla or mandible were included in this study. All subjects were recruited from the Master in Buccofacial Prostheses and Occlusion (Faculty of Odontology, University Complutense of Madrid, Spain). Before treatment, patients were informed of the study objectives, clinical procedures, materials used, advantages and possible risks of the ceramic material, and other therapeutic alternatives. Prior to the study, participants were asked to provide written informed consent. Ninety posterior FPDs were produced and allocated in parallel and randomly to either monolithic zirconia, veneered zirconia or MC restorations. The clinical procedures were performed by two experienced clinicians. All participants received oral hygiene instructions and a professional tooth cleaning prior to prosthetic treatment. The abutment teeth were prepared with a 0.8- to 1-mm-wide circumferential chamfer, an axial reduction of 1 mm and an occlusal reduction of 1.5- to 2.0-mm. A 10- to 15- degree angle of convergence was achieved for the axial walls. Tooth preparations were scanned with an intraoral scanner and the FPDs were designed using specific software. The restorations were then cemented using a resin self-adhesive cement. After cementation, occlusal contacts were evaluated, and the adjusted surfaces were polished using a porcelain polishing kit. The 90 FPDs were examined at 1week (baseline),1, 2 and 2 years by 2 researchers who were not involved in the restorative treatment.

Enrollment: 90 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• One posterior tooth (molar or premolar) to be replaced
• Vital abutments or abutments with an adequate endodontic treatment
• Abutment not crowned previously
• Periodontally healthy abutments with no signs of bone resorption or periapical disease
• Adequate occlusogingival height for an appropiate connector area of at least 9 mm2
• Stable occlusion and the presence of natural dentition in the antagonist arch.

Exclusion criteria

• Patients who require a Fixed Dental Prosthesis of more than three units
• Patients who present reduced crown length (less than 3 mm occlusogingival heigth)
• Poor oral hygiene, high caries activity, or active periodontal disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

Monolithic zirconia

Experimental group

Description:

Monolithic zirconia posterior 3-unit fixed partial dentures

Treatment:

Drug: Monolithic zirconia

Veneered zirconia

Active Comparator group

Description:

Veneered zirconia posterior 3-unit fixed partial dentures

Treatment:

Other: Veneered zirconia

Metal-ceramic

Active Comparator group

Description:

Metal-ceramic posterior 3-unit fixed partial dentures

Treatment:

Other: Metal-ceramic