Tooth WearNCT00223405
Analysis of Enamel Wear Against Ceramic Restorations
An observational study of Tooth Wear, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
1. To characterize the microstructure (fracture toughness, particle size of ceramic, and inter-particle spacing) of three ceramic materials 2. To test the hypothesis that lower fracture toughness of glass and/or crystal phase in ceramics reduce wear damage of enamel. 3. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Wear
- What is being tested?
- crown placement
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Jan 2009
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients needing a crown on a tooth that was opposed by a natural tooth. Patients seeking care in the UTHSCSA dental clinic.
Who may be able to join
- Subjects needing a crown on a posterior tooth that is opposed by a natural tooth.
Who cannot join
- Subjects must be over 18 years of age with good overall health. No contraindications to dental treatment must be present.
- Subjects must have overall good dental health with no active tooth decay (caries) present and no periodontal disease. Pocket depth on all remaining teeth must not be more 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 second premolar, first molar or second molar on any arch. Abutment teeth must be restorable and have a crown root ratio of at least 1:1. Abutment teeth must have a complement of opposing non-restored or minimally restored natural teeth. Minimally restored means nothing beyond a Class II amalgam restoration. Opposing arch cannot be a full coverage restoration or a partial denture. Contralateral tooth must be preferably present.
- Subjects must exhibit good oral hygiene and compliance.
- Subjects must not have any existing condition that could limit the flow of saliva; e.g. saliva flow must be of normal quantity.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
About this study
Official title: Analysis of Clinical Wear Patterns of Tooth Enamel and Ceramic Restorations as a Function of Particle Size, Inter-Particle Spacing and Fracture Toughness of Ceramic Crystals
- To characterize the microstructure (fracture toughness, particle size of ceramic, and inter-particle spacing) of three ceramic materials
- To test the hypothesis that lower fracture toughness of glass and/or crystal phase in ceramics reduce wear damage of enamel.
- To test the hypothesis that smaller sized crystals reduce wear damage of enamel.
- To test the hypothesis that larger inter-particle spacing reduces wear damage of enamel.
- To test the hypothesis that equivalent wear patterns exist in all directions between enamel versus enamel and ceramic versus enamel.
- To test the hypothesis that bite force does not correlate with wear rates.
- To test the hypothesis that salivary flow does not correlate with wear rates.
- To test the hypothesis that a greater amount of wear is not associated with a loss in vertical dimension of occlusion.
- To test the hypothesis that a greater amount of wear does not correlate with secondary cementum deposition as part of the passive eruption process.
- To test the hypothesis that maximum wear occurs early and wear rates level off within the first two years.
- To test the hypothesis that in vitro wear analysis does not correlate with in vivo wear measurements
Read the detailed description
A total of 36 teeth (1 crown per patient) needing crowns will be selected with the following acceptance criteria:
- Subjects must be over 18 years of age with good overall health. No contraindications to dental treatment must be present.
- Subjects must have overall good dental health with no active tooth decay (caries) present and no periodontal disease. Pocket depth on all remaining teeth must not be more 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 second premolar, first molar or second molar on any arch. Abutment teeth must be restorable and have a crown root ratio of at least 1:1. Abutment teeth must have a complement of opposing non-restored or minimally restored natural teeth. Minimally restored means nothing beyond a Class II amalgam restoration. Opposing arch cannot be a full coverage restoration or a partial denture. Contralateral tooth must be preferably present.
- Subjects must exhibit good oral hygiene and compliance.
- Subjects must not have any existing condition that could limit the flow of saliva; e.g. saliva flow must be of normal quantity.
Baseline data will be collected and will consist of:
- General medical history and physical examination
- Primary casts taken with polyvinylsiloxane impression material
- Bite force measurement in Newtons using a gnathodynamometer
- Pocket depths of abutment teeth must be recorded
- Periapical radiographs of abutment teeth. Radiographs will be taken at the exact position with the use of the longitudinal radiographic analysis (LRA) technique.
- Vertical dimension measured from the nasion to the lowest point on the chin
- A saliva sample will be collected to ascertain quality (viscosity) and quantity. The parameters for analysis will be salivary pH, buffer capacity, secretion (ml/min), protein (mg/ml), phosphate (mmol/l), Ca (mval/l), Na (mval/l), K (mval/l).
A total of 36 teeth will be randomly assigned to receive either a metal-ceramic (D'Sign) or an all-ceramic crown (IPS Empress2, Eris EXC). Randomization will be done through a random number table. Teeth will be prepared by two operators: Dr. Josephine Esquivel-Upshaw and Dr. William Rose both from the General Dentistry department. Provisional restorations will be made from Integrity (Dentsply, USA) and final impressions will be made with a polyvinylsiloxane material using the two-stage technique. Master casts will be mounted in centric relation.
A single unit crown will be made from either two types of an all-ceramic material or a metal-ceramic material and cemented with a dual cure resin cement. Adjustments will be made with a high-speed handpiece and a fine diamond bur. Prior to cementation, all adjusted surfaces must be polished or glazed. Occlusal surface thickness of the crowns will be measured at baseline.
Baseline examination will be performed one week after cementation to ensure that the patient is comfortable with the crown and no further adjustments are needed. A polyvinylsiloxane impression will be made of the maxillary and mandibular arches to record the cemented crown and its antagonist arch.
The post-cementation casts will be poured with a Type IV gypsum product to enable proper scanning. A 3D Laserscanner will be used to scan in the x, y and z planes of tooth/teeth casts made from natural teeth. The vertical dimension will be recorded as well as periapical radiographs taken of the abutment teeth.
The subjects will be asked to return after six months of cementation. Polyvinylsiloxane impressions will once again be made of maxillary and mandibular arches and poured with Type IV stone. The antagonist teeth and the crown will be scanned using the 3D Laserscanner. Superimposition of baseline image and the six-month image will be performed and the amount of wear in three dimensions calculated mathematically. Vertical dimension of occlusion will also be determined by measurement of nasion to the lowest point on the chin and periapical radiographs taken of the restored teeth using the LRA technique. This procedure will be repeated every year for the next four years.
The amount of wear in microns will be determined for the x, y and z axes. Data will be subjected to a one-way ANOVA (α = 0.05 ) to determine any significant difference in wear of natural antagonist teeth and the ceramic crowns between baseline and yearly 3D images and also differences in wear between the yearly 3D images. Occlusal thickness of restorations will be determined based on the amount of wear calculated. Any presence of cracks or fractures will be recorded. Correlation of the amount of wear and any changes in vertical dimension and root cementum length will also be determined by comparison of nasion-chin height at different intervals.
- Conditions
- Tooth Wear
- Being tested
- crown placement
- Keywords
- enamel wear against ceramic 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.
crown placementDevice
| Study group | Role | What they receive |
|---|---|---|
| metal-ceramic (D'Sign) o | Metal ceramic crown will be placed Receives: Device: crown placement | |
| an all-ceramic crown (IPS Empress2, Eris EXC). | All ceramic crown will be placed Receives: Device: crown placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
wear of the opposing enamel will be measured yearly for four years
Measured: up to 4 years
Secondary outcomes (2)
wear of ceramic in vivo
Measured: up to 4 years
improved function of crown
Measured: uo to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startApr 2003
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth WearStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- 36 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ivoclar Vivadent AG, University of Florida
- Responsible party
- Sponsor
- Investigators
- Josephine Esquivel-Upshaw, D.M.D.,M.S., Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223405
- Sponsor's protocol ID
- 012-1901-369
- Other IDs
- 116163
- Status last verified
- Apr 2013
- First submitted
- 13 Sep 2005
- Last updated
- 22 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Clinical Wear Patterns of Tooth Enamel and Ceramic Restorations as a Function of Particle Size, Inter-Particle Spacing and Fracture Toughness of Ceramic Crystals
- ClinicalTrials.gov ID
- NCT00223405
- Acronym / sponsor ID
- 012-1901-369
- Conditions
- Tooth Wear
- Keywords
- enamel wear against ceramic crowns
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Ivoclar Vivadent AG, University of Florida
- Study start
- Apr 2003
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 22 Sep 2005 (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.
- To characterize the microstructure (fracture toughness, particle size of ceramic, and inter-particle spacing) of three ceramic materials
- To test the hypothesis that lower fracture toughness of glass and/or crystal phase in ceramics reduce wear damage of enamel.
- To test the hypothesis that smaller sized crystals reduce wear damage of enamel.
- To test the hypothesis that larger inter-particle spacing reduces wear damage of enamel.
- To test the hypothesis that equivalent wear patterns exist in all directions between enamel versus enamel and ceramic versus enamel.
- To test the hypothesis that bite force does not correlate with wear rates.
- To test the hypothesis that salivary flow does not correlate with wear rates.
- To test the hypothesis that a greater amount of wear is not associated with a loss in vertical dimension of occlusion.
- To test the hypothesis that a greater amount of wear does not correlate with secondary cementum deposition as part of the passive eruption process.
- To test the hypothesis that maximum wear occurs early and wear rates level off within the first two years.
- To test the hypothesis that in vitro wear analysis does not correlate with in vivo wear measurements
Detailed description
A total of 36 teeth (1 crown per patient) needing crowns will be selected with the following acceptance criteria:
- Subjects must be over 18 years of age with good overall health. No contraindications to dental treatment must be present.
- Subjects must have overall good dental health with no active tooth decay (caries) present and no periodontal disease. Pocket depth on all remaining teeth must not be more 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 second premolar, first molar or second molar on any arch. Abutment teeth must be restorable and have a crown root ratio of at least 1:1. Abutment teeth must have a complement of opposing non-restored or minimally restored natural teeth. Minimally restored means nothing beyond a Class II amalgam restoration. Opposing arch cannot be a full coverage restoration or a partial denture. Contralateral tooth must be preferably present.
- Subjects must exhibit good oral hygiene and compliance.
- Subjects must not have any existing condition that could limit the flow of saliva; e.g. saliva flow must be of normal quantity.
Baseline data will be collected and will consist of:
- General medical history and physical examination
- Primary casts taken with polyvinylsiloxane impression material
- Bite force measurement in Newtons using a gnathodynamometer
- Pocket depths of abutment teeth must be recorded
- Periapical radiographs of abutment teeth. Radiographs will be taken at the exact position with the use of the longitudinal radiographic analysis (LRA) technique.
- Vertical dimension measured from the nasion to the lowest point on the chin
- A saliva sample will be collected to ascertain quality (viscosity) and quantity. The parameters for analysis will be salivary pH, buffer capacity, secretion (ml/min), protein (mg/ml), phosphate (mmol/l), Ca (mval/l), Na (mval/l), K (mval/l).
A total of 36 teeth will be randomly assigned to receive either a metal-ceramic (D'Sign) or an all-ceramic crown (IPS Empress2, Eris EXC). Randomization will be done through a random number table. Teeth will be prepared by two operators: Dr. Josephine Esquivel-Upshaw and Dr. William Rose both from the General Dentistry department. Provisional restorations will be made from Integrity (Dentsply, USA) and final impressions will be made with a polyvinylsiloxane material using the two-stage technique. Master casts will be mounted in centric relation.
A single unit crown will be made from either two types of an all-ceramic material or a metal-ceramic material and cemented with a dual cure resin cement. Adjustments will be made with a high-speed handpiece and a fine diamond bur. Prior to cementation, all adjusted surfaces must be polished or glazed. Occlusal surface thickness of the crowns will be measured at baseline.
Baseline examination will be performed one week after cementation to ensure that the patient is comfortable with the crown and no further adjustments are needed. A polyvinylsiloxane impression will be made of the maxillary and mandibular arches to record the cemented crown and its antagonist arch.
The post-cementation casts will be poured with a Type IV gypsum product to enable proper scanning. A 3D Laserscanner will be used to scan in the x, y and z planes of tooth/teeth casts made from natural teeth. The vertical dimension will be recorded as well as periapical radiographs taken of the abutment teeth.
The subjects will be asked to return after six months of cementation. Polyvinylsiloxane impressions will once again be made of maxillary and mandibular arches and poured with Type IV stone. The antagonist teeth and the crown will be scanned using the 3D Laserscanner. Superimposition of baseline image and the six-month image will be performed and the amount of wear in three dimensions calculated mathematically. Vertical dimension of occlusion will also be determined by measurement of nasion to the lowest point on the chin and periapical radiographs taken of the restored teeth using the LRA technique. This procedure will be repeated every year for the next four years.
The amount of wear in microns will be determined for the x, y and z axes. Data will be subjected to a one-way ANOVA (α = 0.05 ) to determine any significant difference in wear of natural antagonist teeth and the ceramic crowns between baseline and yearly 3D images and also differences in wear between the yearly 3D images. Occlusal thickness of restorations will be determined based on the amount of wear calculated. Any presence of cracks or fractures will be recorded. Correlation of the amount of wear and any changes in vertical dimension and root cementum length will also be determined by comparison of nasion-chin height at different intervals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metal-ceramic (D'Sign) o | – | Device: crown placementMetal ceramic crown will be placed |
| an all-ceramic crown (IPS Empress2, Eris EXC). | – | Device: crown placementAll ceramic crown will be placed |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients needing a crown on a tooth that was opposed by a natural tooth. Patients seeking care in the UTHSCSA dental clinic.
Key inclusion criteria (1 listed)
- Subjects needing a crown on a posterior tooth that is opposed by a natural tooth.
Key exclusion criteria (6 listed)
- Subjects must be over 18 years of age with good overall health. No contraindications to dental treatment must be present.
- Subjects must have overall good dental health with no active tooth decay (caries) present and no periodontal disease. Pocket depth on all remaining teeth must not be more 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 second premolar, first molar or second molar on any arch. Abutment teeth must be restorable and have a crown root ratio of at least 1:1. Abutment teeth must have a complement of opposing non-restored or minimally restored natural teeth. Minimally restored means nothing beyond a Class II amalgam restoration. Opposing arch cannot be a full coverage restoration or a partial denture. Contralateral tooth must be preferably present.
- Subjects must exhibit good oral hygiene and compliance.
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 |
|---|---|---|
| crown placement | Device | an all-ceramic crown (IPS Empress2, Eris EXC)., metal-ceramic (D'Sign) o |
Primary outcome
wear of the opposing enamel will be measured yearly for four years
Time frame: up to 4 years
2 secondary outcomes
wear of ceramic in vivo
Time frame: up to 4 years
improved function of crown
Time frame: uo to 4 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 22 Nov 2016.
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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 Esquivel-Upshaw, D.M.D.,M.S. principal investigator
The University of Texas Health Science Center at San Antonio
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 The University of Texas Health Science Center at San Antonio 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 1 inclusion and 6 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 22 Nov 2016. 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?
wear of the opposing enamel will be measured yearly for four years (time frame: up to 4 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 22 Nov 2016.