- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00889239
Clinical Performance and Wear Mechanism of Hot-Pressed Ceramic Crowns
May 14, 2015 updated by: Kallaya Suputtamongkol, Mahidol University
The objectives of this study are to characterize the clinical performance and wear mechanisms of all-ceramic posterior crowns.
The wear rate of all-ceramic crowns and opposing enamel in selected patients will be quantified.
The relationship of each subject's maximum clenching force and wear rate will also be analyzed.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
High strength ceramics have been used in dentistry for constructing fixed partial denture.
Their advantages are their acceptable fracture resistance, excellent biocompatibility, moderate opacity, etc.
Because the increase in demand for more esthetic restoration, various ceramic materials have been used as a core material for several all-ceramic systems.
Their properties have been investigated extensively in many in vitro studies.
Currently, there are not much results regarding clinical performance and wear mechanism of ceramic-based prosthesis and more information are required for future research.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bangkok, Thailand, 10400
- faculty of dentistry, Mahidol university
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Occlusion: At least 20 remaining teeth for each patient, and at least one posterior endodontically treated tooth with natural opposing teeth
- Bruxism: No evidence based on an intraoral examination
- Dental history: No evidence of either moderate or severe periodontal disease
- Medical history: Good to excellent general health
Exclusion Criteria:
- Periodontal status: Pocket depth greater than 4 mm
Occlusion:
- Evidence of bruxism or excessive biting or clenching force
- Abutment tooth that opposes a removable partial denture
- Abutment tooth for fixed partial dentures
- Gingival recession of an abutment tooth more than 1 mm from the cementoenamel junction
- Tooth with first or second degree of tooth mobility
- Tooth with extensive carious lesions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
ceramic crown
|
all-ceramic crown
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical performance
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
wear rate
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kallaya Suputtamongkol, Mahidol University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2004
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
April 25, 2009
First Submitted That Met QC Criteria
April 27, 2009
First Posted (Estimate)
April 28, 2009
Study Record Updates
Last Update Posted (Estimate)
May 15, 2015
Last Update Submitted That Met QC Criteria
May 14, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MRG 4780066
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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