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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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

  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. To test the hypothesis that smaller sized crystals reduce wear damage of enamel.
  4. To test the hypothesis that larger inter-particle spacing reduces wear damage of enamel.
  5. To test the hypothesis that equivalent wear patterns exist in all directions between enamel versus enamel and ceramic versus enamel.
  6. To test the hypothesis that bite force does not correlate with wear rates.
  7. To test the hypothesis that salivary flow does not correlate with wear rates.
  8. To test the hypothesis that a greater amount of wear is not associated with a loss in vertical dimension of occlusion.
  9. To test the hypothesis that a greater amount of wear does not correlate with secondary cementum deposition as part of the passive eruption process.
  10. To test the hypothesis that maximum wear occurs early and wear rates level off within the first two years.
  11. 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:

  1. Subjects must be over 18 years of age with good overall health. No contraindications to dental treatment must be present.
  2. 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.
  3. Subjects must have no existing temporomandibular disorder, (e.g. clicking, popping, pain on opening) or parafunctional habits (e.g. bruxism, clenching)
  4. 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.
  5. Subjects must exhibit good oral hygiene and compliance.
  6. 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:

  1. General medical history and physical examination
  2. Primary casts taken with polyvinylsiloxane impression material
  3. Bite force measurement in Newtons using a gnathodynamometer
  4. Pocket depths of abutment teeth must be recorded
  5. Periapical radiographs of abutment teeth. Radiographs will be taken at the exact position with the use of the longitudinal radiographic analysis (LRA) technique.
  6. Vertical dimension measured from the nasion to the lowest point on the chin
  7. 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 groups in NCT00223405
Study groupRoleWhat they receive
metal-ceramic (D'Sign) oMetal 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.

  1. wear of the opposing enamel will be measured yearly for four years

    Measured: up to 4 years

Secondary outcomes (2)
  1. wear of ceramic in vivo

    Measured: up to 4 years

  2. 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.

  1. First posted22 Sep 2005 (estimated)
  2. Study startApr 2003
  3. Primary completionJan 2009
  4. Study completionJan 2009

Resources

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)
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

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.

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