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Trial record 42 of 119 for:    ZIRCONIUM

The Clinical Performance of Inlay Zirconia Bridges

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ClinicalTrials.gov Identifier: NCT02995876
Recruitment Status : Completed
First Posted : December 19, 2016
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Damascus University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Dental Crowns Procedure: Glaze layer Procedure: E-max Press layer Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Clinical Performance of Inlay Zirconia Bridges Using Three Different Designs
Actual Study Start Date : June 2016
Actual Primary Completion Date : January 15, 2018
Actual Study Completion Date : August 15, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Zirconium

Arm Intervention/treatment
No Intervention: Zirconia and E-max Press
The first design is going to be fabricated with CAD/CAM Zirconia and the occlusal surface from E-max Press.
Experimental: Zirconia and E-max Press and Glaze
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 a glaze layer to improve adhesion.
Procedure: Glaze layer
A coating of a glaze layer will be used at the inner surface of the bridge to improve adhesion

Experimental: Zirconia and E-max Press twice
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 an E-max Press layer to improve adhesion.
Procedure: E-max Press layer
A coating of E-max Press layer will be used at the inner surface of the bridge to improve adhesion




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Good oral hygiene
  2. Low susceptibility to caries
  3. Parallel alignment of abutment teeth
  4. Immobility of the abutment teeth
  5. Minimum height of abutment teeth ≥ 5 mm (connector thickness)
  6. 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.

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): NCT02995876


Locations
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Syrian Arab Republic
Department of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria
Damascus, Syrian Arab Republic, DM20AM18
Sponsors and Collaborators
Damascus University
Investigators
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Principal Investigator: Mansour Abo Alkasab, DDS MSc PhD student in Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria
Study Director: Jihad Abo Nassar, DDS MSc PhD Associate Professor of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria

Publications of Results:
Other Publications:

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Responsible Party: Damascus University
ClinicalTrials.gov Identifier: NCT02995876     History of Changes
Other Study ID Numbers: UDDS-FixPro-02-2016
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No