Clinical Evaluation of Monolithic Zirconia Crowns

NCT ID: NCT04943315

Last Updated: 2023-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-06

Study Completion Date

2023-07-15

Brief Summary

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

Detailed Description

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Seventy patients requiring at least one crown 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. Seventy posterior crowns were produced and allocated in parallel and randomly to either monolithic third-generation zirconia, or metal-ceramic (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- 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 crowns 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 70 crowns were examined at 1week (baseline),1, 2 and 3 years by 2 researchers who were not involved in the restorative treatment.

Conditions

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Dental Materials

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Monolithic zirconia

To assess the clinical performance and survival of posterior monolithic zirconia crowns

Group Type EXPERIMENTAL

Monolithic zirconia

Intervention Type PROCEDURE

posterior crowns

Metal-ceramic

To assess the clinical performance and survival of posterior metal-ceramic crowns

Group Type ACTIVE_COMPARATOR

Metal-ceramic

Intervention Type PROCEDURE

posterior crowns

Interventions

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Monolithic zirconia

posterior crowns

Intervention Type PROCEDURE

Metal-ceramic

posterior crowns

Intervention Type PROCEDURE

Other Intervention Names

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Katana

Eligibility Criteria

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Inclusion Criteria

* One posterior tooth (molar or premolar) to be crowned
* Vital abutment or abutment with an adequate endodontic treatment
* Abutment not crowned previously
* Periodontally healthy abutment with no signs of bone resorption or periapical disease.
* Adequate occlusogingival height ≥ 4 mm.
* Stable occlusion and the presence of natural antagonist tooth.

Exclusion Criteria

* Patients who present reduced crown length (less than 4 mm occlusogingival height).
* Poor oral hygiene, high caries activity, or active periodontal disease
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kuraray Co. Ltd

UNKNOWN

Sponsor Role collaborator

Universidad Complutense de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria J Suarez, PhD

Role: STUDY_DIRECTOR

Universidad Complutense de Madrid

Locations

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Faculty of Odontology

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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4157246

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

University Complutense Madrid

Identifier Type: -

Identifier Source: org_study_id

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