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The Influence of Porcelain Fused to Metal ( PFM) and Zirconia Crowns on Periodontal Health

Primary Purpose

Periodontitis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Zirconia crown
Porcelain metal crown
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

inclusion criteria:

  1. Patient age 18 - 85 years old
  2. In need for one or more fixed partial prosthetic crown or bridge

exclusion criteria:

  1. Smokers
  2. Active periodontal disease
  3. history of compromising systemic disease
  4. Allergy to materials used in the study
  5. current drug abuse
  6. Pregnant or intend to become pregnant
  7. severe salivary gland dysfunction
  8. Severe medical complications ( organ transplants, cancer, immunocompromised, or undergoing long-term antibiotic or steroid therapy )

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Z Crown

    PFM Crown

    Arm Description

    A Zirconia crown will be provided to patients.

    A Porcelain metal crown will provided to patients.

    Outcomes

    Primary Outcome Measures

    PgE2 ( Prostaglandin E2)
    Gingival cervicular fluid samples will be attempt be planning Periotrom paper in the mesial and distal aspect of the experimental teeth. This samples will be assayed for PgE2 ( Prostaglandin E2) using Elyza kit. The concentration of PGE2 in gingival crevicular fluid will be examined around each tooth receiving a crown.

    Secondary Outcome Measures

    PIaque index
    The clinical examination will include measurement of PIaque index( soft tissue deposite around teeth)
    GIingival index
    The clinical examination will include measurement of the GIingival index (gingival inflamation around teeth)
    Pocket depth
    The clinical examination will include measurement of Pocket depth around teeth
    Clinical attachment level
    The clinical examination will include measurement of the Clinical attachment level around teeth
    bone level
    Periapical radiography will be obtain using customized film holding with Vinylpolysiloxan bite registration. Measurements of alveolar bone level will be performed on the digital images by a single examiner, using custom-made software.

    Full Information

    First Posted
    May 14, 2015
    Last Updated
    May 31, 2015
    Sponsor
    Rambam Health Care Campus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02461823
    Brief Title
    The Influence of Porcelain Fused to Metal ( PFM) and Zirconia Crowns on Periodontal Health
    Official Title
    The Influence of Porcelain Fused to Metal ( PFM) and Zirconia Crowns on Periodontal Health
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    June 2016 (Anticipated)
    Study Completion Date
    August 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rambam Health Care Campus

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Investigate the influence of the crown tye Porcelain fused to metal or Zirconia on periodontal health.
    Detailed Description
    Porcelain fused to metal (PFM) has been used in dentistry for the last five decades. Zirconia (zirconium oxide, ZrO2) is the white crystalline powder oxide of the naturally occurring metal zirconium. Research of the medical utilization of zirconia dates back to the late 1960s. However, its utilization in dentistry did not start until the 1990s, when zirconia began to be used as a form of endodontic posts and implant abutments. The current literature contains studies that investigated the influence of zirconia implants and abutments on periodontal tissue, but to the investigators' knowledge, no work has been yet published which compares the influences of crown types on hard and soft tissues. This prospective study will be conducted in the Department of Periodontology and in the Department of Maxillofacial Rehabilitation at Rambam Health Care Campus.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Z Crown
    Arm Type
    Experimental
    Arm Description
    A Zirconia crown will be provided to patients.
    Arm Title
    PFM Crown
    Arm Type
    Active Comparator
    Arm Description
    A Porcelain metal crown will provided to patients.
    Intervention Type
    Device
    Intervention Name(s)
    Zirconia crown
    Intervention Description
    patients will receive a Zirconia crown, the Zirconia crown will cover the natural crown.
    Intervention Type
    Device
    Intervention Name(s)
    Porcelain metal crown
    Intervention Description
    patients will receive a porcelain fused to metal crown, the Porcelain metal crown will cover the natural crown.
    Primary Outcome Measure Information:
    Title
    PgE2 ( Prostaglandin E2)
    Description
    Gingival cervicular fluid samples will be attempt be planning Periotrom paper in the mesial and distal aspect of the experimental teeth. This samples will be assayed for PgE2 ( Prostaglandin E2) using Elyza kit. The concentration of PGE2 in gingival crevicular fluid will be examined around each tooth receiving a crown.
    Time Frame
    4 months
    Secondary Outcome Measure Information:
    Title
    PIaque index
    Description
    The clinical examination will include measurement of PIaque index( soft tissue deposite around teeth)
    Time Frame
    4 months
    Title
    GIingival index
    Description
    The clinical examination will include measurement of the GIingival index (gingival inflamation around teeth)
    Time Frame
    4 months
    Title
    Pocket depth
    Description
    The clinical examination will include measurement of Pocket depth around teeth
    Time Frame
    4 months
    Title
    Clinical attachment level
    Description
    The clinical examination will include measurement of the Clinical attachment level around teeth
    Time Frame
    4 months
    Title
    bone level
    Description
    Periapical radiography will be obtain using customized film holding with Vinylpolysiloxan bite registration. Measurements of alveolar bone level will be performed on the digital images by a single examiner, using custom-made software.
    Time Frame
    4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    inclusion criteria: Patient age 18 - 85 years old In need for one or more fixed partial prosthetic crown or bridge exclusion criteria: Smokers Active periodontal disease history of compromising systemic disease Allergy to materials used in the study current drug abuse Pregnant or intend to become pregnant severe salivary gland dysfunction Severe medical complications ( organ transplants, cancer, immunocompromised, or undergoing long-term antibiotic or steroid therapy )
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dr Ilan Hirsh, DMD
    Phone
    +972508800822
    Email
    i_hirsh@rambam.health.gov.il
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dr Zvi Gutmacher, DMD
    Phone
    +97248542983
    Email
    dr_zviu3@013net.net
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dr Ilan Hirsh, DMD
    Organizational Affiliation
    Rambam Health Care Campus , Department of Periodiontology, Haifa, Israel 31096
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Influence of Porcelain Fused to Metal ( PFM) and Zirconia Crowns on Periodontal Health

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