Tooth WearNCT02289781
Wear of Enamel Against Polished Zirconia Crowns
An observational study of Tooth Wear, run by University of Florida at 1 site in United States.
Trial summary
A randomized, controlled clinical trial is designed to analyze the wear of enamel by opposing polished monolithic zirconia crowns and by the polished veneer surfaces of metal-ceramic crowns. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Wear
- What is being tested?
- posterior crowns
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Aug 2022
- Phase
- Observational
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients accessing care in a dental clinc needing full coverage crowns.
Who may be able to join
- Subjects must be over 21 years of age and in good overall health. No contraindications to dental treatment are present
- Subjects must be in good overall good dental health and are at a low caries risk, with no active tooth decay (caries), and no periodontal disease. Periodontal pocket depths on all remaining teeth are not greater than 4 mm
- Subjects must have no existing temporomandibular disorder, (e.g. clicking, popping, pain on opening) or parafunctional habits (e.g. bruxism, clenching)
- Subjects must need a crown on either a first or second premolar or first or second molar in any arch. Abutment teeth must be restorable and have a crown:root ratio of at least 1:1. Abutment teeth must have a full complement of opposing non-restored or minimally restored natural teeth. Minimally restored means the teeth contain no restoration greater than a Class II amalgam restoration. The opposing arch must not have a full coverage restoration or a partial denture. The contralateral tooth and its antagonist are present
- Subjects must exhibit good oral hygiene and compliance with oral hygiene instructions as determined by the amount of plaque present on tooth surfaces
- Subjects must exhibit a normal flow of saliva. Subjects with any medical pathologies that limit salivary flow volume or who require a chronic intake of medications that minimize flow of saliva will be excluded from the study
- Subjects must be willing to pay $500 for the clinic incidentals and they must be compliant with yearly appointments
Who cannot join
- anything that does not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wear of Enamel Antagonists by Polished Ceramic Surfaces
A randomized, controlled clinical trial is designed to analyze the wear of enamel by opposing polished monolithic zirconia crowns and by the polished veneer surfaces of metal-ceramic crowns. This single-blind pilot study will involve a total of 30 teeth that require full coverage crowns that oppose natural antagonist teeth.
The objectives of this research are to test the following hypotheses: (1) differences between mean wear of antagonist enamel by polished monolithic zirconia crowns and by the polished veneer surface of metal-ceramic crowns are statistically significant; (2) differences between mean wear of antagonist enamel by opposing polished monolithic zirconia crowns and enamel by opposing enamel are statistically significant; and (3) differences between mean antagonist wear of enamel by opposing polished veneer surfaces of metal-ceramic crowns and enamel by opposing enamel are statistically significant.
Read the detailed description
To participate in this study a crown will need to be place on one of the back teeth. This generally occurs when the back tooth has a big filling and there is a risk for fracture of the tooth or a root canal has been performed on the tooth. An initial x-ray of the tooth and the surrounding teeth will be done to make sure that there is enough bone supporting the tooth that will be crowned.
A receive local anesthesia will be used in the area where the crown will be made. The tooth area may need to be build-up with a filling material if there is not enough tooth structure remaining. Once this happens, then a high-speed drill will be used to a grind down of the tooth material using to a make smaller size of the original tooth. A small thread will be used to make space between the gums and tooth so an accurate replica of the tooth can be made. A temporary crown will be made to go over the prepared tooth and will cement until the final crown is ready to be cemented.
The extra procedures will be done to measure bite force to see how much force is exerted with the teeth. Other extra procedures include the six month and yearly impressions as well as scanning of your teeth to aid in the measurement of wear.
Participants will be randomly assigned (much like the flip of a coin) to receive either a crown that has metal in it or a crown that is all-ceramic. Both of these materials are considered standard of care in dental practice.
- Conditions
- Tooth Wear
- Being tested
- posterior crowns
- Medical subject headings
- Tooth Wear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
posterior crownsDevice
teeth will be prepared to receive posterior crown made of either zirconia or metal-ceramic material
| Study group | Role | What they receive |
|---|---|---|
| Zirconia posterior crowns | Monolithic zirconia crowns which are polished and non-glazed Receives: Device: posterior crowns | |
| Metal-Ceramic posterior crowns | Metal-supported glass-ceramic veneered crowns which are polished and non-glazed Receives: Device: posterior crowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline, 1 year, 2 years, and 3 years wear of Enamel Antagonist
The wear of the enamel opposing the monolithic zirconia will be measured and compared with wear with the metal-ceramic crowns by using scanning technology to scan the teeth at baseline and then at the succeeding time periods. Also, impressions of the teeth will be used on a laser scanner to measure the volume loss on the crowns and the opposing teeth.
Measured: Change from baseline, 1 year, 2 years, and 3 years
Secondary outcomes (1)
Change from baseline, 1 year, 2 years, and 3 years in the wear of Zirconia and Metal-Ceramic Crowns
The wear of the enamel opposing the monolithic zirconia will be measured and compared with wear with the metal-ceramic crowns by using scanning technology to scan the teeth at baseline and then at the succeeding time periods. Also, impressions of the teeth will be used on a laser scanner to measure the volume loss on the crowns and the opposing teeth.
Measured: Change from baseline, 1 year, 2 years, and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startApr 2013
- Primary completionAug 2022
- Study completionAug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tooth WearStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- 3M Pharmaceuticals Pty Limited
- Responsible party
- Sponsor
- Investigators
- Josephine F. Esquivel-Upshaw, D.M.D., M.S., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02289781
- Sponsor's protocol ID
- IRB201200002
- Other IDs
- 00104254
- Status last verified
- Sep 2024
- First submitted
- 7 Nov 2014
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
F Esquivel-Upshaw J, Hsu SM, Bohorquez AC, Abdulhameed N, Scheiffele GW, Kim M, Neal D, Chai J, Ren F. Novel methodology for measuring intraoral wear in enamel and dental restorative materials. Clin Exp Dent Res. 2020 Dec;6(6):677-685. doi: 10.1002/cre2.322. Epub 2020 Sep 21.
PubMed 32955159
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wear of Enamel Antagonists by Polished Ceramic Surfaces
- ClinicalTrials.gov ID
- NCT02289781
- Acronym / sponsor ID
- IRB201200002
- Conditions
- Tooth Wear
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- 3M Pharmaceuticals Pty Limited
- Study start
- Apr 2013 (actual)
- Primary completion
- Aug 2022 (actual)
- Study completion
- Aug 2022 (actual)
- First posted
- 13 Nov 2014 (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.
A randomized, controlled clinical trial is designed to analyze the wear of enamel by opposing polished monolithic zirconia crowns and by the polished veneer surfaces of metal-ceramic crowns. This single-blind pilot study will involve a total of 30 teeth that require full coverage crowns that oppose natural antagonist teeth.
The objectives of this research are to test the following hypotheses: (1) differences between mean wear of antagonist enamel by polished monolithic zirconia crowns and by the polished veneer surface of metal-ceramic crowns are statistically significant; (2) differences between mean wear of antagonist enamel by opposing polished monolithic zirconia crowns and enamel by opposing enamel are statistically significant; and (3) differences between mean antagonist wear of enamel by opposing polished veneer surfaces of metal-ceramic crowns and enamel by opposing enamel are statistically significant.
Detailed description
To participate in this study a crown will need to be place on one of the back teeth. This generally occurs when the back tooth has a big filling and there is a risk for fracture of the tooth or a root canal has been performed on the tooth. An initial x-ray of the tooth and the surrounding teeth will be done to make sure that there is enough bone supporting the tooth that will be crowned.
A receive local anesthesia will be used in the area where the crown will be made. The tooth area may need to be build-up with a filling material if there is not enough tooth structure remaining. Once this happens, then a high-speed drill will be used to a grind down of the tooth material using to a make smaller size of the original tooth. A small thread will be used to make space between the gums and tooth so an accurate replica of the tooth can be made. A temporary crown will be made to go over the prepared tooth and will cement until the final crown is ready to be cemented.
The extra procedures will be done to measure bite force to see how much force is exerted with the teeth. Other extra procedures include the six month and yearly impressions as well as scanning of your teeth to aid in the measurement of wear.
Participants will be randomly assigned (much like the flip of a coin) to receive either a crown that has metal in it or a crown that is all-ceramic. Both of these materials are considered standard of care in dental practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zirconia posterior crowns | – | Device: posterior crownsMonolithic zirconia crowns which are polished and non-glazed |
| Metal-Ceramic posterior crowns | – | Device: posterior crownsMetal-supported glass-ceramic veneered crowns which are polished and non-glazed |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients accessing care in a dental clinc needing full coverage crowns.
Key inclusion criteria (7 listed)
- Subjects must be over 21 years of age and in good overall health. No contraindications to dental treatment are present
- Subjects must be in good overall good dental health and are at a low caries risk, with no active tooth decay (caries), and no periodontal disease. Periodontal pocket depths on all remaining teeth are not greater than 4 mm
- Subjects must have no existing temporomandibular disorder, (e.g. clicking, popping, pain on opening) or parafunctional habits (e.g. bruxism, clenching)
- Subjects must need a crown on either a first or second premolar or first or second molar in any arch. Abutment teeth must be restorable and have a crown:root ratio of at least 1:1. Abutment teeth must have a full complement of opposing non-restored or minimally restored natural teeth. Minimally restored means the teeth contain no restoration greater than a Class II amalgam restoration. The opposing arch must not have a full coverage restoration or a partial denture. The contralateral tooth and its antagonist are present
- Subjects must exhibit good oral hygiene and compliance with oral hygiene instructions as determined by the amount of plaque present on tooth surfaces
Key exclusion criteria (1 listed)
- anything that does not meet inclusion criteria
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 |
|---|---|---|
| posterior crownsteeth will be prepared to receive posterior crown made of either zirconia or metal-ceramic material | Device | Metal-Ceramic posterior crowns, Zirconia posterior crowns |
Primary outcome
Change from baseline, 1 year, 2 years, and 3 years wear of Enamel Antagonist
Time frame: Change from baseline, 1 year, 2 years, and 3 years
The wear of the enamel opposing the monolithic zirconia will be measured and compared with wear with the metal-ceramic crowns by using scanning technology to scan the teeth at baseline and then at the succeeding time periods. Also, impressions of the teeth will be used on a laser scanner to measure the volume loss on the crowns and the opposing teeth.
1 secondary outcome
Change from baseline, 1 year, 2 years, and 3 years in the wear of Zirconia and Metal-Ceramic Crowns
Time frame: Change from baseline, 1 year, 2 years, and 3 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 1 Oct 2024.
- Derived from this study: PubMed 32955159F Esquivel-Upshaw J, Hsu SM, Bohorquez AC, Abdulhameed N, Scheiffele GW, Kim M, Neal D, Chai J, Ren F. Novel methodology for measuring intraoral wear in enamel and dental restorative materials. Clin Exp Dent Res. 2020 Dec;6(6):677-685. doi: 10.1002/cre2.322. Epub 2020 Sep 21.
- Individual participant dataSharing planned: No
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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.
Josephine F. Esquivel-Upshaw, D.M.D., M.S. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth Wear, run by University of Florida at 1 site in United States.
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 7 inclusion and 1 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 1 Oct 2024. 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 United States. 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?
Change from baseline, 1 year, 2 years, and 3 years wear of Enamel Antagonist (time frame: Change from baseline, 1 year, 2 years, and 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02289781, which also lists 1 linked publication.
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 1 Oct 2024.