Prosthetic Outcomes and Clinical Performance of Implant Supported Zirconia Crowns

May 11, 2024 updated by: Susan Hattar, University of Jordan

Prosthetic Outcomes and Clinical Performance of Two Types of Monolithic Zirconia-based Screw-retained Crowns. A Randomized Clinical Trial

To compare biological, technical, radiographic, and patient-reported outcomes of two types of monolithic zirconia crowns screw-retained to implant.

To assess whether the new form of multilayered zirconia crowns will show similar survival and success rate to conventional monolithic Zirconia screw-retained to implants in molar and premolar regions.

First Null Hypothesis: Multilayered monolithic zirconia crowns would have similar survival, success rate compared to conventional monolithic zirconia implant supported crowns.

Second Null hypothesis: There would be no difference in clinical and patients related outcomes between multilayered and conventional monolithic zirconia implant supported crowns.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Study design:

A short-randomized controlled trial study, the (PICO) study design: population will be patients from Jordan University Hospital with implants planned for single screw-retained zirconia crowns in the posterior site (premolar or molar), intervention will be the multilayer monolithic screw-retained zirconia crowns over implants, the comparator is the conventional monolithic zirconia crowns over implants, and the main outcomes will be the prosthetic/technical outcomes, survival and success rates in addition to radiographic, patient-reported outcomes, and biological parameters.

Methodology The patients who fulfilled the inclusion/exclusion criteria and entered the study will have a fully digital workflow starting from data acquisition using an intraoral scanner (3Shape TRIOS® 5) , Ti-base abutment design and CAD/CAM milling of the two types of monolithic zirconia blanks (IPS e.max® ZirCAD Prime and IPS e.max® ZirCAD LT).

The fabricated zirconia crowns in both groups will have the same treatment and will be cemented to the Ti-base abutment according to the (APC) concept; alumina airborne-particle abrasion 50-μm at 1 bar for 15-20 seconds, intaglio surface primed using MDP for 60 seconds and air blown for 5 seconds, and finally cemented to the abutment by phosphate monomer resin cement PANAVIA™ V5(Blatz-Alvarez-Compendium-APC-2016, n.d.).

On the other hand, the Ti-base abutment: height will be standardized at 4mm, and the base abutment surface will have blasting with alumina particles of 50 μm at 2-bar pressure for 15-20 seconds at a 10-mm step-over distance at an angle of 45 degrees.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Jordan
      • Amman, Jordan, 11181
        • The university ofJordan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Partially edentulous area with suitable restorative space more than 5.5 mm
  • At least 18 years of age
  • Opposing natural teeth or fixed restorations supported by teeth or implants.
  • Generally good health (ASA I, ASA II)
  • Participant complies with good oral hygiene practices (BOP and PI less than 20%)
  • Healthy integrated implant/s without signs of periimplantitis in the posterior site planned for single tooth replacement (in premolar or molar areas)
  • Patients received bone-level implants, RC Straumann Implants.

Exclusion Criteria:

  • Inability to provide consent.
  • Temporomandibular disorders
  • Smoking of more than 10 cigarettes per day
  • Untreated caries or periodontal disease of remaining dentition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Graded monolithic Zirconia Crowns
3Y-TZP/5Y-TZP zirconia crown
Other: Graded Zirconia Crown
monolithic implant supported crown
Active Comparator: Conventional monolithic Zirconia Crowns
3Y-TZP zirconia crowns
Other: Conventional Zirconia Crown
monolithic implant supported crown

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical & Biological Outcomes
Time Frame: Baseline, 6 months, 12 months
The abutments and restoration will be evaluated clinically by two blinded investigators, according to the modified United States Public Health Service (USPHS) criteria USPHS criteria involve four Scales: Alpha, Bravo, Charlie, Delta The criteria of evaluation include: Restoration fracture, Abutment Fracture, Loosening of the restoration, Screw-access hole restoration, Occlusal Wear, Anatomical Form, Color match, Proximal contact, Occlusal Contact, Marginal Fit, Periodontal parameters.
Baseline, 6 months, 12 months
Survival and Success rate
Time Frame: 6 months, 12 months

All patients will be evaluated for success and survival of restorations at 6 months and 1 year after placement of the restorations (Follow-ups).

The success rate is defined as the number of restorations that did not change over time. The survival rate is defined as the number of restorations that did not require replacement.
6 months, 12 months
Patient reported outcomes
Time Frame: 6 months, 12 months
Patient satisfaction in terms of the shape and shade of the crown, their ability to chew (function) and floss (proximal contact) and their overall satisfaction with the restoration provided will be assessed by a questionnaire based on a five-grade ordinal category scale (extremely satisfied, satisfied, neutral, dissatisfied and extremely dissatisfied). Each patient was asked to fill out the questionnaire themselves to ensure as little bias as possible.
6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jordan

Investigators

  • Principal Investigator: Susan Hattar, Professor, University of Jordan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

January 21, 2024

First Submitted That Met QC Criteria

May 11, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 11, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Susan Hattar

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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