Clinical trial NCT05707780: Clinical Evaluation of Resin Matrix Ceramic Posterior Crowns
Official title: Clinical Evaluation of Resin Matrix Ceramic and Zirconia Posterior Crowns
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Materials
Keywords: crowns
monolithic zirconia
resin matrix ceramic
clinical evaluation
survival
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: BEGO GmbH
First posted: 2023-02-01
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Survival and success rates
timeFrame: 3 years
Secondary 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: 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: 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: Patient satisfaction at 3 years
timeFrame: 3 years
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Faculty of Odontology
Study officials:
affiliation: UNIVERSITY COMPLUTENSE OF MADRID
name: MARIA JESUS SUAREZ, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UNIVERSITY COMPLUTENSE OF MADRID
name: JESUS PELAEZ, PhD
role: PRINCIPAL_INVESTIGATOR
References: