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

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

Study Overview

• Status: Unknown
• Conditions: Periodontitis
• Intervention / Treatment: Device: Zirconia crown; Device: Porcelain metal crown

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 )

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PIaque index	The clinical examination will include measurement of PIaque index( soft tissue deposite around teeth)	4 months
GIingival index	The clinical examination will include measurement of the GIingival index (gingival inflamation around teeth)	4 months
Pocket depth	The clinical examination will include measurement of Pocket depth around teeth	4 months
Clinical attachment level	The clinical examination will include measurement of the Clinical attachment level around teeth	4 months
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.	4 months

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Investigators: Principal Investigator: Dr Ilan Hirsh, DMD, Rambam Health Care Campus , Department of Periodiontology, Haifa, Israel 31096

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: May 14, 2015
• First Submitted That Met QC Criteria: May 31, 2015
• First Posted (Estimate): June 3, 2015

Study Record Updates

• Last Update Posted (Estimate): June 3, 2015
• Last Update Submitted That Met QC Criteria: May 31, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: 078 -15-RMB CTIL