Clinical trial NCT04879498: Clinical Evaluation of Monolithic Zirconia FPDs
Official title: Clinical Evaluation of Monolithic Zirconia and Metal-ceramic Posterior Fixed Partial Dentures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Materials
Keywords: fixed partial dentures
clinical evaluation
monolithic zirconia
veneered zirconia
survival
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: Ivoclar Vivadent AG
First posted: 2021-05-10
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of restorations at baseline
timeFrame: Baseline
measure: Quality of restorations at 1 year
timeFrame: 1 year
measure: Quality of restorations at 2 years
timeFrame: 2 years
measure: Quality of restorations at 3 years
timeFrame: 3 years
measure: Plaque Index (PI) at baseline
timeFrame: Baseline
measure: Plaque Index (PI) at 1 year
timeFrame: 1 year
measure: Plaque Index (PI) at 2 years
timeFrame: 2 years
measure: Plaque Index (PI) at 3 years
timeFrame: 3 years
measure: Gingival Index (GI) at baseline
timeFrame: Baseline
measure: Gingival Index (GI) at 1 year
timeFrame: 1 year
measure: Gingival Index (GI) at 2 years
timeFrame: 2 years
measure: Gingival Index (GI) at 3 years
timeFrame: 3 years
measure: Margin stability at baseline
timeFrame: Baseline
measure: Margin stability at 1 year
timeFrame: 1 year
measure: Margin stability at 2 years
timeFrame: 2 years
measure: Margin stability at 3 years
timeFrame: 3 years
measure: Probing depth at baseline
timeFrame: Baseline
measure: Probing depth at 1 year
timeFrame: 1 year
measure: Probing depth at 2 years
timeFrame: 2 years
measure: Probing depth at 3 years
timeFrame: 3 years
measure: Patient satisfaction at 3 years
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
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