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

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ClinicalTrials.gov Identifier: NCT02461823
Recruitment Status : Unknown
Verified May 2015 by Ilan Hirsh MD, Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : June 3, 2015
Last Update Posted : June 3, 2015
Sponsor:
Information provided by (Responsible Party):
Ilan Hirsh MD, Rambam Health Care Campus

Brief Summary:
Investigate the influence of the crown tye Porcelain fused to metal or Zirconia on periodontal health.

Condition or disease Intervention/treatment Phase
Periodontitis Device: Zirconia crown Device: Porcelain metal crown Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Influence of Porcelain Fused to Metal ( PFM) and Zirconia Crowns on Periodontal Health
Study Start Date : June 2015
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Zirconium

Arm Intervention/treatment
Experimental: Z Crown
A Zirconia crown will be provided to patients.
Device: Zirconia crown
patients will receive a Zirconia crown, the Zirconia crown will cover the natural crown.

Active Comparator: PFM Crown
A Porcelain metal crown will provided to patients.
Device: Porcelain metal crown
patients will receive a porcelain fused to metal crown, the Porcelain metal crown will cover the natural crown.




Primary Outcome Measures :
  1. PgE2 ( Prostaglandin E2) [ Time Frame: 4 months ]

    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 :
  1. PIaque index [ Time Frame: 4 months ]
    The clinical examination will include measurement of PIaque index( soft tissue deposite around teeth)

  2. GIingival index [ Time Frame: 4 months ]
    The clinical examination will include measurement of the GIingival index (gingival inflamation around teeth)

  3. Pocket depth [ Time Frame: 4 months ]
    The clinical examination will include measurement of Pocket depth around teeth

  4. Clinical attachment level [ Time Frame: 4 months ]
    The clinical examination will include measurement of the Clinical attachment level around teeth

  5. bone level [ Time Frame: 4 months ]
    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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 )

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): NCT02461823


Contacts
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Contact: Dr Ilan Hirsh, DMD +972508800822 i_hirsh@rambam.health.gov.il
Contact: Dr Zvi Gutmacher, DMD +97248542983 dr_zviu3@013net.net

Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Dr Ilan Hirsh, DMD Rambam Health Care Campus , Department of Periodiontology, Haifa, Israel 31096

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Responsible Party: Ilan Hirsh MD, Senior staff Member Department of Periodontology, Rambam Health Care Campus, Haifa, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT02461823     History of Changes
Other Study ID Numbers: 078 -15-RMB CTIL
First Posted: June 3, 2015    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases