NCT00223405

Brief Summary

  1. 1.To characterize the microstructure (fracture toughness, particle size of ceramic, and inter-particle spacing) of three ceramic materials
  2. 2.To test the hypothesis that lower fracture toughness of glass and/or crystal phase in ceramics reduce wear damage of enamel.
  3. 3.To test the hypothesis that smaller sized crystals reduce wear damage of enamel.
  4. 4.To test the hypothesis that larger inter-particle spacing reduces wear damage of enamel.
  5. 5.To test the hypothesis that equivalent wear patterns exist in all directions between enamel versus enamel and ceramic versus enamel.
  6. 6.To test the hypothesis that bite force does not correlate with wear rates.
  7. 7.To test the hypothesis that salivary flow does not correlate with wear rates.
  8. 8.To test the hypothesis that a greater amount of wear is not associated with a loss in vertical dimension of occlusion.
  9. 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. 10.To test the hypothesis that maximum wear occurs early and wear rates level off within the first two years.
  11. 11.To test the hypothesis that in vitro wear analysis does not correlate with in vivo wear measurements

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

November 22, 2016

Status Verified

April 1, 2013

Enrollment Period

5.8 years

First QC Date

September 13, 2005

Last Update Submit

November 18, 2016

Conditions

Tooth Wear

Keywords

enamel wear against ceramic crowns

Outcome Measures

Primary Outcomes (1)

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

    up to 4 years

Secondary Outcomes (2)

  • wear of ceramic in vivo

    up to 4 years

  • improved function of crown

    uo to 4 years

Study Arms (2)

metal-ceramic (D'Sign) o

Metal ceramic crown will be placed

Device: crown placement

an all-ceramic crown (IPS Empress2, Eris EXC).

All ceramic crown will be placed

Device: crown placement

Interventions

crown placementDEVICE
an all-ceramic crown (IPS Empress2, Eris EXC).metal-ceramic (D'Sign) o

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients needing a crown on a tooth that was opposed by a natural tooth. Patients seeking care in the UTHSCSA dental clinic.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

MeSH Terms

Conditions

Tooth Wear

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Josephine Esquivel-Upshaw, D.M.D.,M.S.

    The University of Texas Health Science Center at San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

April 1, 2003

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

November 22, 2016

Record last verified: 2013-04

Locations

US(1)