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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02461823
• Other study ID #: 078 -15-RMB CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: May 14, 2015
• Last updated: May 31, 2015
• Start date: June 2015
• Est. completion date: August 2016

Study information

• Verified date: May 2015
• Source: Rambam Health Care Campus
• Contact: Dr Ilan Hirsh, DMD
• Phone: +972508800822
• Email: i_hirsh[@]rambam.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: August 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Periodontitis

Intervention

Device:
• Zirconia crown
patients will receive a Zirconia crown, the Zirconia crown will cover the natural crown.
• Porcelain metal crown
patients will receive a porcelain fused to metal crown, the Porcelain metal crown will cover the natural crown.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	PIaque index	The clinical examination will include measurement of PIaque index( soft tissue deposite around teeth)	4 months	No
Secondary	GIingival index	The clinical examination will include measurement of the GIingival index (gingival inflamation around teeth)	4 months	No
Secondary	Pocket depth	The clinical examination will include measurement of Pocket depth around teeth	4 months	No
Secondary	Clinical attachment level	The clinical examination will include measurement of the Clinical attachment level around teeth	4 months	No
Secondary	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	No