CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 36 enrolled
Drug / intervention
Full ceramic crowns or 3-unit fixed partial dentures.device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00591942
NCT00591942N/ACompleted

Outcome Evaluation of All Ceramic Crowns and Fixed Partial Dentures Bonded With Two Different Dental Cements.

Clark Stanford·interventional·Posted Jan 11, 2008·Updated Mar 8, 2018

In Brief

A clinical study evaluating Full ceramic crowns or 3-unit fixed partial dentures. for Sensitivity to Dental Cements and 2 related conditions. Completed, enrolled 36 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 11, 2008
Enrollment StartNov 1, 2004
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 18.5 years ago

Interventions

Full ceramic crowns or 3-unit fixed partial dentures.device

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.