Clinical Outcomes of Zirconia-reinforced Lithium Silicate Partial Coverage Crowns Compared to Lithium Disilicate Partial Coverage Crowns

February 4, 2019 updated by: Hanaa Sayed abdo Hassan Nassar, Cairo University

Clinical Outcomes of Zirconia-reinforced Lithium Silicate Partial Coverage Crowns Compared to Lithium Disilicate Partial Coverage Crowns: A Randomized Controlled Clinical Trial

The purpose of this randomized controlled clinical trial is to evaluate the clinical outcomes of Partial Coverage Restorations fabricated with zirconia-reinforced lithium silicate ceramic system compared to partial coverage restorations fabricated with lithium disilicate ceramic system.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is constructed to assess in patients with carious vital posterior teeth whether the use of Vita Suprinity® (VITA Zahnfabrik H. Rauter GmbH & Co.KG- Germany) Zirconia reinforced lithium silicate partial coverage restorations will result in higher survival rates and better patient related outcome scores compared to IPS-e.max® CAD (Ivoclar Vivadent AG, Schaan - Liechtenstein) lithium disilicate partial coverage restorations.

Study Type

Interventional

Enrollment (Actual)

46

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 Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of Oral and Dental Medicine- Cairo University

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:

  • Participants:
  • Good oral hygiene, papillary bleeding index (PBI) < 35%.
  • Positive patient acceptance to participate in the trial.

Teeth:

  • Carious class II or MOD lesions
  • Vital upper or lower posterior teeth with no signs of irreversible pulpitis.
  • Normal occlusion
  • Single tooth restoration (no edentulous space that requires fixed prosthesis)

Exclusion Criteria:

  • Participants
  • Pregnancy.
  • Disabilities.
  • Systemic disease or severe medical complications.
  • Bad oral hygiene
  • Heavy smoking.
  • Xerostomia.
  • Lack of compliance.
  • Evidence of severe bruxism, clenching, or temporomandibular disorders.

Teeth:

  • Deep carious defects (close to pulp, less than 1 mm distance).
  • Periapical pathology or signs of pulpal pathology.
  • Tooth hypersensitivity.
  • Rampant caries.
  • Non-vital or endodontically treated teeth.
  • Sever periodontal affection.
  • Tooth mobility

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Suprinity
Vita Suprinity® (VITA Zahnfabrik H. Rauter GmbH & Co.KG- Germany) Zirconia reinforced lithium silicate PCRs
Other: Vita Suprinity
zirconia reinforced lithium silicate partial coverage restorations
ACTIVE_COMPARATOR: e.max
IPS-e.max® CAD (Ivoclar Vivadent AG, Schaan - Liechtenstein) lithium disilicate PCRs
Other: IPS e.max
lithium disilicate partial coverage restorations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival rate
Time Frame: 12 month
Absolute failure is defined by clinical unacceptable fracture and crack development which required a replacement of the entire restoration, and/or secondary caries as well as endodontic complications
12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Restorations with Marginal gap as assessed visually by US public health service criteria
Time Frame: 12 month
restorations with visually detectable margin, catch or penetration of explorer at baseline or a change from baseline on visual analogue scale at 12 month
12 month
Restorations with Marginal discoloration as assessed visually by US public health service criteria
Time Frame: 12 month
restorations with visually detectable discoloration along margin at baseline or a change from baseline on visual analogue scale at 12 month
12 month
Restorations with color mismatch with adjacent teeth as assessed visually by US public health service criteria
Time Frame: 12 month
restorations with visually detectable color mismatch with adjacent teeth at baseline or a change from baseline on visual analogue scale at 12 month
12 month
Restorations with surface roughness as assessed tactilely by US public health service criteria
Time Frame: 12 month
restorations with tactilely detectable rough surface at baseline or a change from baseline on visual analogue scale at 12 month
12 month
Restorations developed secondary caries as assessed visually by US public health service criteria
Time Frame: 12 month
restorations with visually detectable secondary caries at baseline or a change from baseline on visual analogue scale at 12 month
12 month

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Chair: Hesham Katamish, PHD, Cairo university

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 (ACTUAL)

May 1, 2017

Primary Completion (ACTUAL)

June 18, 2018

Study Completion (ACTUAL)

July 18, 2018

Study Registration Dates

First Submitted

August 4, 2016

First Submitted That Met QC Criteria

August 5, 2016

First Posted (ESTIMATE)

August 10, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2019

Last Update Submitted That Met QC Criteria

February 4, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CEBD-CU-2016-08-177

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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