A Clinical Trial of the Impact of Speed and Conventional Sintering on Ultra-thin, Highly Translucent, Multilayered Zirconia Laminate Restorations

March 1, 2023 updated by: Hams Hamed Abdelrahman

Effect of Speed Sintering on Translucency and Microstructure of High Versus Low Translucent Zirconia Veneers: a Randomized Clinical Trial

A Minimally invasive esthetic restorative approach with the advancement of highly translucent multilayered monolithic zirconia ceramic can provide minimal thickness that affords high strength and esthetics without the need for layering porcelain. The effect of sintering conditions on yttria-partially stabilized zirconia is essential for the long-term success of such restorations.

The study aims to evaluate the clinical performance of speed and conventional sintering on ultra-thin, highly translucent, multilayered zirconia laminate restorations with minimum invasive tooth preparation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

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

  • Egypt
    • Azarita
      • Alexandria, Azarita, Egypt, 00203
        • Recruiting
        • Outpatient clinics of Faculty of Dentistry, Alexandria University, Egypt
        • Contact:
          • Faculty of Dentistry
          • Phone Number: (203) 4868308
        • Principal Investigator:
          • Mahinour A El Moniem, Msc

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 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients able to understand and sign the informed consent form.
  • physically and psychologically able to undergo conventional restorative procedures.
  • Good oral hygiene with no signs of periapical pathology or periodontal disease. (periodontal screening index 0-1).
  • Slight malposition.
  • Teeth with spacing.
  • Teeth with discoloration.
  • Patient having natural teeth as opposing dentition

Exclusion Criteria:

  • Insufficient surface enamel (60%).
  • Abutments with subgingival restorations or root caries.
  • Parafunctional habits.
  • Lack of opposite occluding dentition in the area intended for restoration.
  • mandibular prognathism and maxillary retrognathism

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
Active Comparator: Conventional sintering
Other: Laminate veneers with conventional sintering
Zirconia specimens will be sintered using conventional sintering cycle in a conventional furnace according to the manufacturer instructions.
Experimental: Speed sintering
Other: Laminate veneers with speed sintering
Zirconia specimens will be sintered using speed sintering cycle in a conventional furnace according to the manufacturer instructions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in clinical performance
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months

Patients will be recalled every 3 months for one year follow up. The clinical evaluation and color measurement will be based on the modified California Dental Association (CDA)/Ryge criteria of evaluation as shown

Examiners will evaluate the zirconia Veneers for the following:

  1. Color match.
  2. Zirconia surface.
  3. Marginal discoloration.
  4. Marginal integrity.
  5. Clinical evaluation of the completed restorations will be performed using a double-blind assessment method
Baseline, 3 months, 6 months, 9 months, 12 months

Collaborators and Investigators

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

Sponsor

Hams Hamed Abdelrahman

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 (Actual)

February 1, 2023

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

February 21, 2023

First Submitted That Met QC Criteria

March 1, 2023

First Posted (Actual)

March 2, 2023

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • TP_22

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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