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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00889239
Other study ID # MRG 4780066
Secondary ID
Status Completed
Phase N/A
First received April 25, 2009
Last updated May 14, 2015
Start date May 2004
Est. completion date April 2015

Study information

Verified date May 2015
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility 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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
lithia-disilicate-based crown
all-ceramic crown

Locations

Country Name City State
Thailand Faculty of Dentistry, Mahidol University Bangkok

Sponsors (2)

Lead Sponsor Collaborator
Mahidol University Thailand Research Fund

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical performance 5 years No
Secondary wear rate 2 years No