Skip to main content
OpenTrials
Completed

NCT Number: NCT02861729

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Oral and Dental Medicine- Cairo University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vita Suprinity

Other

zirconia reinforced lithium silicate partial coverage restorations

IPS e.max

Other

lithium disilicate partial coverage restorations

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 10, 2016
Registry last updated
Feb 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.