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Completed

NCT Number: NCT02995876

The Clinical Performance of Inlay Zirconia Bridges

When missing tooth structure or teeth are replaced, minimal biologic risk should be involved to re-establish function and esthetics. The increased use of the adhesive technique and preservation of dental tissues have greatly impacted conservative tooth preparation design. The development use of zirconia technology and all-ceramic systems has opened the potential for fabrication inlays zirconia bridges with durability and good aesthetics.

The purpose of this study is to clinically evaluate the placement of inlay bridge made of a Y-TZP framework veneered with a pressed ceramic and bonded with a completely adhesive approach in the replacement of a single missing tooth.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria

Damascus, DM20AM18, Syria

About this study

This study evaluates the use of inlay bridge made of Zirconia and all ceramic systems with three designs in the replacement process of one single tooth (i.e. a missing premolar or molar.) The first design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from e-max press.

The second design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from e-max press and the internal surface coated with glaze layer to improve the adhesion.

The third design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from e-max press and the internal surface coated with a layer of e-max ceramic press to improve the adhesion.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Good oral hygiene
  • Low susceptibility to caries
  • Parallel alignment of abutment teeth
  • Immobility of the abutment teeth
  • Minimum height of abutment teeth ≥ 5 mm (connector thickness)
  • Maximum mesio-distal extension of the inter-dental gap of 9 mm (width of premolar) or 12 mm (width of molar)

Exclusion criteria

  • Severe para-functional habits.
  • Short clinical crowns (<5 mm)
  • Extensive defects of the clinical crown,
  • Loosening of teeth because of factors related to the periodontal tissues.

Treatment and study plan

Glaze layer

Procedure

A coating of a glaze layer will be used at the inner surface of the bridge to improve adhesion

E-max Press layer

Procedure

A coating of E-max Press layer will be used at the inner surface of the bridge to improve adhesion

Primary outcomes

  1. Change in marginal fit

    Time frame: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application

    To examine if there is a gap between inlay margins and tooth cavity margins .It will be measured by a probe.

  2. Change in Material Integrity

    Time frame: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application

    To examine macroscopically the presence of cracks or fractures in the veneering ceramic (retainers or pontics) or any fractures at the connectors.

  3. Change in the Retention Status

    Time frame: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application

    The resistance of a prosthesis to displacement will be measured.

Secondary outcomes

  1. Change in Marginal Color Matching

    Time frame: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application

    Examination will be done macroscopically to detect the presence of any difference in color between the margins of the tooth and inlays

Other outcomes

  1. Change in Sensitivity

    Time frame: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application

    The presence of any spontaneous or stimulated pain will be assumed.

  2. Change in Patients' Satisfaction

    Time frame: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application

    A questionnaire will be used to detect the level of satisfaction regarding function and shade

  3. Change in Shade

    Time frame: Immediately within five minutes following cementation (T1), 3 months (T2), 6 months (T3), 12 months (T4) following application

    The shade is going to be determined using Vita(R) shade guide.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

The Clinical Performance of Inlay Zirconia Bridges Using Three Different Designs

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 19, 2016
Registry last updated
Sep 11, 2018

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.

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