The Influence of Porcelain Fused to Metal ( PFM) and Zirconia Crowns on Periodontal Health
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
Investigate the influence of the crown tye Porcelain fused to metal or Zirconia on periodontal health.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
June 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedJune 3, 2015
May 1, 2015
1 year
May 14, 2015
May 31, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
PIaque index
4 months
GIingival index
4 months
Pocket depth
4 months
Clinical attachment level
4 months
bone level
4 months
Study Arms (2)
Z Crown
EXPERIMENTALA Zirconia crown will be provided to patients.
PFM Crown
ACTIVE COMPARATORA Porcelain metal crown will provided to patients.
Interventions
patients will receive a Zirconia crown, the Zirconia crown will cover the natural crown.
patients will receive a porcelain fused to metal crown, the Porcelain metal crown will cover the natural crown.
Eligibility Criteria
You may qualify if:
- Patient age 18 - 85 years old
- In need for one or more fixed partial prosthetic crown or bridge
You may not qualify if:
- 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 )
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr Ilan Hirsh, DMD
Rambam Health Care Campus , Department of Periodiontology, Haifa, Israel 31096
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior staff Member Department of Periodontology, Rambam Health Care Campus, Haifa
Study Record Dates
First Submitted
May 14, 2015
First Posted
June 3, 2015
Study Start
June 1, 2015
Primary Completion
June 1, 2016
Study Completion
August 1, 2016
Last Updated
June 3, 2015
Record last verified: 2015-05