Dental Restoration WearNCT00737308
Properties and Clinical Performance of Zirconia-based Dental Ceramics
A study testing ceramic crown in people with Dental Restoration Wear, run by Mahidol University at 2 sites in Thailand.
Trial summary
The objectives of this study are to determine the clinical performance of zirconia-based dental prostheses and their related properties. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Restoration Wear
- What is being tested?
- ceramic crown
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesThailand
- Study dates
- Jun 2008to 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 exam
- 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 clenching force, Abutment tooth that opposes a removable partial denture, Abutment teeth 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
2 sites in 1 country.
Thailand2 sites
Faculty of Dentistry, Mahidol University
Bangkok, 10400
Faculty of Dentistry, Mahidol University
Pyathai, Bangkok, 10400
About this study
The objectives of this study are to determine the clinical performance of zirconia-based dental prostheses and their related properties.
Read the detailed description
Zirconia has been used in dentistry since 2000 for constructing fixed partial denture. Its advantages are high fracture resistance, excellent biocompatibility, moderate opacity, etc. Because the increase in demand for more esthetic restoration, zirconia becomes more popular for use as a core material for all-ceramic systems. Its properties have been investigated extensively in many in vitro studies. However, clinical performance of zirconia-based restorations would require a period of time before the results can be assessed. Currently, there are not much results regarding clinical performance of zirconia-based prosthesis and more information are required for future research.
- Conditions
- Dental Restoration Wear
- Being tested
- ceramic crown
- Keywords
- crowns, ceramics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ceramic crownOther
Also called Zirconia
Zirconia
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | crown for clasp Receives: Other: ceramic crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
ceramic crown fracture
Measured: 2 years
Secondary outcomes (1)
masticatory function
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 posted19 Aug 2008 (estimated)
- Study startJun 2008
- 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 Dental Restoration 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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT00737308
- Sponsor's protocol ID
- MRG5180145
- Status last verified
- May 2015
- First submitted
- 17 Aug 2008
- 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
- Properties and Clinical Performance of Zirconia-based Dental Ceramics
- ClinicalTrials.gov ID
- NCT00737308
- Acronym / sponsor ID
- MRG5180145
- Conditions
- Dental Restoration Wear
- Keywords
- crowns, ceramics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Thailand Research Fund
- Study start
- Jun 2008
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 19 Aug 2008 (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 determine the clinical performance of zirconia-based dental prostheses and their related properties.
Detailed description
Zirconia has been used in dentistry since 2000 for constructing fixed partial denture. Its advantages are high fracture resistance, excellent biocompatibility, moderate opacity, etc. Because the increase in demand for more esthetic restoration, zirconia becomes more popular for use as a core material for all-ceramic systems. Its properties have been investigated extensively in many in vitro studies. However, clinical performance of zirconia-based restorations would require a period of time before the results can be assessed. Currently, there are not much results regarding clinical performance of zirconia-based prosthesis and more information are required for future research.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: ceramic crowncrown for clasp |
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 exam
- Dental history: No evidence of either moderate or severe periodontal disease
- Medical history: Good to excellent general health
Key exclusion criteria (2 listed)
- Periodontal status: Pocket depth greater than 4 mm
- Occlusion: Evidence of bruxism or excessive clenching force, Abutment tooth that opposes a removable partial denture, Abutment teeth 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
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 |
|---|---|---|
| ceramic crownAlso: ZirconiaZirconia | Other | A |
Primary outcome
ceramic crown fracture
Time frame: 2 years
1 secondary outcome
masticatory function
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.
Related trials for Dental Restoration Wear
Not yet recruiting
Evaluation of Clinical Wear and Surface Roughness of Partial Restorations Produced by Additive and Subtractive Manufacturing Methods: A Split-Mouth Randomized Controlled Clinical Trial
CAD/CAM Space Maintainer, 3D Printing
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ceramic crown in people with Dental Restoration Wear, run by Mahidol University at 2 sites 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 2 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 2 sites 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?
ceramic crown fracture (time frame: 2 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.