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

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ClinicalTrials.gov Identifier: NCT02861729
Recruitment Status : Completed
First Posted : August 10, 2016
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Hanaa Sayed abdo Hassan Nassar, Cairo University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Partial Coverage Restoration Other: Vita Suprinity Other: IPS e.max Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: split-mouth design
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Outcomes of Zirconia-reinforced Lithium Silicate Partial Coverage Crowns Compared to Lithium Disilicate Partial Coverage Crowns: A Randomized Controlled Clinical Trial
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : June 18, 2018
Actual Study Completion Date : July 18, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861729


Locations
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Egypt
Faculty of Oral and Dental Medicine- Cairo University
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: Hesham Katamish, PHD Cairo University

Publications:

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Responsible Party: Hanaa Sayed abdo Hassan Nassar, PHD student, Cairo University
ClinicalTrials.gov Identifier: NCT02861729     History of Changes
Other Study ID Numbers: CEBD-CU-2016-08-177
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hanaa Sayed abdo Hassan Nassar, Cairo University:
Partial coverage restoration
Crown
Posterior teeth
All ceramic
Zirconia reinforced lithium silicate
Lithium disilicate
CAD/CAM

Additional relevant MeSH terms:
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Lithium Carbonate
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs