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Analysis of Enamel Wear Against Ceramic Restorations

This study has been completed.
Sponsor:
Collaborators:
Ivoclar Vivadent
University of Florida
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00223405
First received: September 13, 2005
Last updated: April 15, 2013
Last verified: April 2013
History of Changes
  Purpose
  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

Condition Intervention Phase
Tooth Wear
 Device: crown placement
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • wear of the opposing enamel will be measured yearly for four years [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • wear of ceramic in vivo [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • improved function of crown [ Time Frame: uo to 4 years ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: April 2003
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: metal-ceramic (D'Sign) o
Metal ceramic crown will be placed
 Device: crown placement
Active Comparator: an all-ceramic crown (IPS Empress2, Eris EXC).
All ceramic crown will be placed
 Device: crown placement

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subjects needing a crown on a posterior tooth that is opposed by a natural tooth.

Exclusion 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00223405

Locations
United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Ivoclar Vivadent
University of Florida
Investigators
Principal Investigator: Josephine Esquivel-Upshaw, D.M.D.,M.S. University of Texas Health Science Center at San Antonio
  More Information

No publications provided

Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00223405     History of Changes
Obsolete Identifiers: NCT01128231
Other Study ID Numbers: 012-1901-369, 116163
Study First Received: September 13, 2005
Last Updated: April 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center at San Antonio:
enamel wear against ceramic crowns

Additional relevant MeSH terms:
Tooth Wear
Tooth Attrition
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on June 18, 2013