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Outcome Evaluation of Ceramic Crowns Using Two Different Dental Cements

This study is ongoing, but not recruiting participants.

Sponsored by: University of Iowa
Information provided by: University of Iowa
ClinicalTrials.gov Identifier: NCT00591942
  Purpose

The restoration of indirect partial and full coverage restorations in dentistry necessitates the use of a luting agent to act as a means of mechanical and potentially, chemical retention of the restoration. Upon the introduction of the first generation of glass Ionomer cements for use as a luting agent, an elevated short-term post operative hypersentivity was reported. In part, this adverse event was considered to be due to a desiccating effect of the cement as water is utilized in the setting reaction and thus a desiccation of the dentinal tubules was proposed as a potential mechanism leading to disruption of the neurosensory odontoblasts. Further materials development in the field of dental cement luting agents has lead to the introduction to the current market of resin formulations that have an alternative mechanism of setting. Consequently, there are anecdotal reports of a decrease in the incidence of post-operative sensitivity but no comparison with the effect of conventionally used dentin desensitizing agents as a part of the bonding process of the restoration.

The purpose of this trial is a single blinded parallel design randomized clinical trial to evaluate the perceived incidence of post-operative sensitivity when full coverage all ceramic crowns or short-span three unit fixed partial dentures (dental bridge) is fabricated in the posterior part of the mouth. The dental crowns or bridges will be bonded with conventional glass ionomer cement or a Urethane dimethacrylate / Bis-GMA composite resin dental cement. Outcome measures will be both objective clinical criteria and the use of a calibrated pain survey instrument.


Condition Intervention Phase
Sensitivity to Dental Cements
Dental Crowns
Dental Three-Unit Bridges
 Device: Full ceramic crowns or 3-unit fixed partial dentures.
 Phase III

MedlinePlus related topics:   Dentures   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Basic Science, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study
Official Title:   Outcome Evaluation of All Ceramic Crowns and Fixed Partial Dentures Bonded With Two Different Dental Cements.

Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • The perceived incidence of post-operative sensitivity using the Wong-Baker Scale when full coverage all ceramic crowns or short-span three unit fixed partial dentures (dental bridge) is fabricated in the posterior part of the mouth. [ Time Frame: Outcome is measured: 24 hrs., 7 days, and 6, 12, 18 and 24 months following seating of the restorations ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective clinical criteria using USPHS criteria for Clinical Evaluation and GI, PI and Bleeding Index (Loe and Silness, 1963 and Silness and Loe, 1964) [ Time Frame: Two years post seating of the restorations ] [ Designated as safety issue: No ]

Enrollment:   36
Study Start Date:   November 2004
Estimated Study Completion Date:   December 2009
Estimated Primary Completion Date:   December 2009 (Final data collection date for primary outcome measure)

Intervention Details:
    Device: Full ceramic crowns or 3-unit fixed partial dentures.
    Subjects who met the inlcusion/excluson criteria received two ceramic crowns or one three-unit dental bridge on posterior teeth. The crowns and dental bridge were cemented using two different dental adhesives. Follow-up to assess sensitivity of the crowns/bridges occur at 24 hrs. and 1 week post seating by telephone. Clinical visits to assess sensitivity and the integrity of the crowns/bridges occur at 6, 12, 18 and 24 months post seating of the restorations.
Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion and Exclusion Criteria:

  • Subject shall be in need of a maximum of two porcelain crowns on their posterior teeth. In the case of missing single teeth, the adjacent retainers shall be in need of complete coverage restorations and provide sufficient support for a conventional 3-unit fixed partial denture.
  • Cantilever pontics shall not be performed.
  • Prospective teeth shall be vital and not in need of root canal endodontic therapy.
  • The tooth in question shall be "responsive" to conventional Endodontic tests. These tests shall include a positive response to thermal stimulation (CO2 ice) and/or electric pulp testing (EPT).
  • The tooth in question shall be in occlusion with the opposing dentition. Subjects shall have an Angle Class I occlusion with preferably canine eccentric lateral guidance. In selected cases a mutual protected occlusion is acceptable if lateral guidance can be minimized on the restorations at risk. Subjects with intraoral ornamental metallic devices (e.g., posts, etc) shall be excluded.
  • The tooth in question shall not be a retainer for a Removable Partial Denture (i.e., a surveyed crown) although the tooth may lack a mesial or distal contact.
  • The tooth in question shall have periodontal stability (probing depths < 3mm, dental mobility < 1).
  • The tooth shall not be in need of surgical crown lengthening for reasons of restoration or periodontal status.
  • Subjects involved in other clinical trial protocols utilizing a similar protocol as proposed shall be excluded.
  • The subject shall not have any known allergies to any materials used in this protocol. Subjects who need antibiotic prophylaxis for SBE are acceptable for inclusion.
  • Subjects of child bearing age shall have a urine pregnancy test. Pregnant subjects shall be excluded.
  • Subjects shall be available for a potential recall period of five years
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00591942

Locations
United States, Iowa
The University of Iowa College of Dentistry    
      Iowa City, Iowa, United States, 52242-1010

Sponsors and Collaborators
University of Iowa

Investigators
Principal Investigator:     Clark Stanford, DDS, PhD     The University of Iowa    
  More Information

Responsible Party:   The University of Iowa ( Clark Stanford, DDS, PhD, Principal Investigator )
Study ID Numbers:   Ivoclar Vivadent Crown-Bridge
First Received:   December 26, 2007
Last Updated:   December 26, 2007
ClinicalTrials.gov Identifier:   NCT00591942
Health Authority:   United States: Institutional Review Board

Keywords provided by University of Iowa:
dental cement  
ceramic crowns  
three-unit bridges  
sensitivity  

ClinicalTrials.gov processed this record on August 29, 2008

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