Wear of Enamel Antagonist to Two Different Types of Monolithic Zirconia Monolithic Zirconia

June 16, 2021 updated by: Sara Ismail Mohamed Hussein, Cairo University

Wear of Enamel Antagonist to Two Different Types of Monolithic Zirconia: A Randomized Clinical Trial

The aim of the present study is to evaluate the wear of enamel opposed by Newly Introduced Gradient Monolithic Zirconia compared to that of enamel opposed by Full Strength Monolithic Zirconia

Study Overview

Detailed Description

The aim of the present study is to evaluate the wear of enamel opposed by Newly Introduced Gradient Monolithic Zirconia compared to that of enamel opposed by Full Strength Monolithic Zirconia Teeth preparation and impressions, placement and permanent cementation of the final restoration using resin cement, and optical scanning of both the restoration and the opposing tooth. Follow up postoperatively after six and twelve months, and optical scanning of both the restoration and the opposing tooth.

Study Type

Interventional

Enrollment (Anticipated)

26

Phase

  • Not Applicable

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

-

All subjects are required to be:

  1. From 18-50 years old, be able to read and sign the informed consent document.
  2. Have no active periodontal or pulpal diseases, have teeth with good restorations.
  3. Psychologically and physically able to withstand conventional dental procedures.
  4. Patients planned for a single coverage restoration in the posterior area.
  5. Patients with a natural (not crowned) opposing antagonist.
  6. Able to return for follow-up examinations and evaluation.

Exclusion Criteria:

  • Patient less than 18 or more than 50 years 2. Patients with severe clenching or bruxing habits. 3. Patient with active resistant periodontal diseases 4. Patients with poor oral hygiene and uncooperative patients 5. Pregnant women 6. Patients in the growth stage with partially erupted teeth 7. Psychiatric problems or unrealistic expectations 8. Lack of opposing dentition at the area of interest. 9. Presence of dental prosthesis in the opposing arch at the area of interest.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: tested material
Newly Introduced Gradient Monolithic Zirconia (Intervention)
Fabrication of full-coverage crowns over posterior teeth using Newly Introduced Gradient Monolithic Zirconia to measure wear
Active Comparator: comparator material
Full Strength Monolithic Zirconia (Comparator)
Fabrication of full-coverage crowns over posterior teeth using Full Strength Monolithic Zirconia to measure wear

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enamel wear of teeth opposing the restorations to be tested opposing to tested restorations
Time Frame: one year
measured by Geomagic professional software
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wear of restorations to tested opposed to natural teeth
Time Frame: one year
measured by Geomagic professional software
one year

Collaborators and Investigators

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

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 (Anticipated)

September 1, 2021

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

January 28, 2021

First Submitted That Met QC Criteria

March 12, 2021

First Posted (Actual)

March 15, 2021

Study Record Updates

Last Update Posted (Actual)

June 18, 2021

Last Update Submitted That Met QC Criteria

June 16, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 171020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

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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