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

NCT ID: NCT02461823

Last Updated: 2015-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Z Crown

A Zirconia crown will be provided to patients.

Group Type EXPERIMENTAL

Zirconia crown

Intervention Type DEVICE

patients will receive a Zirconia crown, the Zirconia crown will cover the natural crown.

PFM Crown

A Porcelain metal crown will provided to patients.

Group Type ACTIVE_COMPARATOR

Porcelain metal crown

Intervention Type DEVICE

patients will receive a porcelain fused to metal crown, the Porcelain metal crown will cover the natural crown.

Interventions

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Zirconia crown

patients will receive a Zirconia crown, the Zirconia crown will cover the natural crown.

Intervention Type DEVICE

Porcelain metal crown

patients will receive a porcelain fused to metal crown, the Porcelain metal crown will cover the natural crown.

Intervention Type DEVICE

Eligibility Criteria

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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 )
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Ilan Hirsh MD

Senior staff Member Department of Periodontology, Rambam Health Care Campus, Haifa

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr Ilan Hirsh, DMD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus , Department of Periodiontology, Haifa, Israel 31096

Central Contacts

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Dr Ilan Hirsh, DMD

Role: CONTACT

+972508800822

Dr Zvi Gutmacher, DMD

Role: CONTACT

+97248542983

Other Identifiers

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078 -15-RMB CTIL

Identifier Type: -

Identifier Source: org_study_id

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