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Outcome Evaluation of All Ceramic Crowns and Fixed Partial Dentures Bonded With Two Different Dental Cements.
Sponsor study identifier
interventional
36
1 country
1
Study Start
November 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2009
Actual (reported)Study Completion
December 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2009
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2004
Date type not reportedThis date has not been verified as actual or estimated.
December 26, 2007
Actual (reported)January 11, 2008
Actual (reported)December 2009
Actual (reported)December 2009
Actual (reported)March 8, 2018
Actual (reported)Incidence of Post-operative Pain (Yes/no)
Scores reported are subjects reporting any pain (yes/no)
Outcome is measured: 24 hrs., 7 days, and 6, 12, 18 and 24 months following seating of the restorations
36 subjects (TOTAL) received two crowns each and another group of 11 subjects received a three-unit fixed dental bridge. Cross over design. One dental crown cemented with VivaGlass Cement/subject. 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.
36 subjects (TOTAL) received two crowns each and another group of 11 subjects received a three-unit fixed dental bridge. Cross Over design. One dental crown per subject was cemented with Multilink Dental Cement. 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.
Subjects who met the inclusion/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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The University of Iowa College of Dentistry
Iowa City, Iowa, 52242-1010, United States
Clark Stanford, DDS, PhD
University of Iowa
36 participants (actual enrollment reported by the registry).
First Submitted
December 26, 2007
First Posted
January 11, 2008
Study Start
Contact the study team to confirm eligibility.
November 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2009
Actual (reported)Study Completion
December 2009
Actual (reported)Last Updated
March 8, 2018
Results First Posted
March 8, 2018
Record last verified: 2018-02
IPD data is tied to Hippa identifiers and therefore cannot be released
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Source: ClinicalTrials.gov.
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