PeriodontitisNCT02461823
The Influence of Porcelain Fused to Metal ( PFM) and Zirconia Crowns on Periodontal Health
A study testing Zirconia crown and Porcelain metal crown in people with Periodontitis, run by Rambam Health Care Campus.
Trial summary
Investigate the influence of the crown tye Porcelain fused to metal or Zirconia on periodontal health. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Zirconia crown and Porcelain metal crown
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient age 18 - 85 years old
- In need for one or more fixed partial prosthetic crown or bridge
Who cannot join
- 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 )
Trial locations and contacts
No sites are listed yet.
About this study
Investigate the influence of the crown tye Porcelain fused to metal or Zirconia on periodontal health.
Read the 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.
- Conditions
- Periodontitis
- Being tested
- Zirconia crown, Porcelain metal crown
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zirconia crownDevice
patients will receive a Zirconia crown, the Zirconia crown will cover the natural crown.
Porcelain metal crownDevice
patients will receive a porcelain fused to metal crown, the Porcelain metal crown will cover the natural crown.
| Study group | Role | What they receive |
|---|---|---|
| Z Crown | Experimental | A Zirconia crown will be provided to patients. Receives: Device: Zirconia crown |
| PFM Crown | Active comparator | A Porcelain metal crown will provided to patients. Receives: Device: Porcelain metal crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (5)
PIaque index
The clinical examination will include measurement of PIaque index( soft tissue deposite around teeth)
Measured: 4 months
GIingival index
The clinical examination will include measurement of the GIingival index (gingival inflamation around teeth)
Measured: 4 months
Pocket depth
The clinical examination will include measurement of Pocket depth around teeth
Measured: 4 months
Clinical attachment level
The clinical examination will include measurement of the Clinical attachment level around teeth
Measured: 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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilan Hirsh MD, Rambam Health Care Campus
- Investigators
- Dr Ilan Hirsh, DMD, Principal investigator, Rambam Health Care Campus , Department of Periodiontology, Haifa, Israel 31096
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02461823
- Sponsor's protocol ID
- 078 -15-RMB CTIL
- Status last verified
- May 2015
- First submitted
- 14 May 2015
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Porcelain Fused to Metal ( PFM) and Zirconia Crowns on Periodontal Health
- ClinicalTrials.gov ID
- NCT02461823
- Acronym / sponsor ID
- 078 -15-RMB CTIL
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 3 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigate the influence of the crown tye Porcelain fused to metal or Zirconia on periodontal health.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Z Crown | Experimental | Device: Zirconia crownA Zirconia crown will be provided to patients. |
| PFM Crown | Active comparator | Device: Porcelain metal crownA Porcelain metal crown will provided to patients. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient age 18 - 85 years old
- In need for one or more fixed partial prosthetic crown or bridge
Key exclusion criteria (8 listed)
- Smokers
- Active periodontal disease
- history of compromising systemic disease
- Allergy to materials used in the study
- current drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zirconia crownpatients will receive a Zirconia crown, the Zirconia crown will cover the natural crown. | Device | Z Crown |
| Porcelain metal crownpatients will receive a porcelain fused to metal crown, the Porcelain metal crown will cover the natural crown. | Device | PFM Crown |
Primary outcome
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.
5 secondary outcomes
PIaque index
Time frame: 4 months
GIingival index
Time frame: 4 months
Pocket depth
Time frame: 4 months
Clinical attachment level
Time frame: 4 months
bone level
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Ilan Hirsh, DMD principal investigator
Rambam Health Care Campus , Department of Periodiontology, Haifa, Israel 31096
Questions about this trial
What is this clinical trial studying?
A study testing Zirconia crown and Porcelain metal crown in people with Periodontitis, run by Rambam Health Care Campus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Ilan Hirsh, DMD (+972508800822, i_hirsh@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PgE2 ( Prostaglandin E2) (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.