Ceramic and Dental Enamel WearNCT00889239
Clinical Performance and Wear Mechanism of Hot-Pressed Ceramic Crowns
A study testing lithia-disilicate-based crown in people with Ceramic and Dental Enamel Wear, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Ceramic and Dental Enamel Wear
- What is being tested?
- lithia-disilicate-based crown
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- May 2004to Apr 2015
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Ceramic and Dental Enamel Wear
- Being tested
- lithia-disilicate-based crown
- Keywords
- ceramic, wear rate, opposing enamel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lithia-disilicate-based crownOther
Also called ceramic crown
all-ceramic crown
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | ceramic crown Receives: Other: lithia-disilicate-based crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance
Measured: 5 years
Secondary outcomes (1)
wear rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (estimated)
- Study startMay 2004
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ceramic and Dental Enamel WearStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Thailand Research Fund
- Responsible party
- Principal investigator, Kallaya Suputtamongkol, Mahidol University
- Investigators
- Kallaya Suputtamongkol, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889239
- Sponsor's protocol ID
- MRG 4780066
- Status last verified
- May 2015
- First submitted
- 25 Apr 2009
- Last updated
- 15 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance and Wear Mechanism of Hot-Pressed Ceramic Crowns
- ClinicalTrials.gov ID
- NCT00889239
- Acronym / sponsor ID
- MRG 4780066
- Conditions
- Ceramic and Dental Enamel Wear
- Keywords
- ceramic, wear rate, opposing enamel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Thailand Research Fund
- Study start
- May 2004
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 28 Apr 2009 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: lithia-disilicate-based crownceramic crown |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Periodontal status: Pocket depth greater than 4 mm
- Occlusion:
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 |
|---|---|---|
| lithia-disilicate-based crownAlso: ceramic crownall-ceramic crown | Other | A |
Primary outcome
Clinical performance
Time frame: 5 years
1 secondary outcome
wear rate
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2015.
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.
Kallaya Suputtamongkol principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lithia-disilicate-based crown in people with Ceramic and Dental Enamel Wear, run by Mahidol University at 1 site in Thailand.
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 4 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: finished, as of the sponsor's last update on 15 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical performance (time frame: 5 years). 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 15 May 2015.