Outcome Evaluation of Ceramic Crowns Using Two Different Dental Cements
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.
|Sensitivity to Dental Cements Dental Crowns Dental Three-unit Bridges||Device: Full ceramic crowns or 3-unit fixed partial dentures.||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Basic Science
|Official Title:||Outcome Evaluation of All Ceramic Crowns and Fixed Partial Dentures Bonded With Two Different Dental Cements.|
- 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 ]
- 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 ]
|Study Start Date:||November 2004|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Device: Full ceramic crowns or 3-unit fixed partial dentures.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00591942
|United States, Iowa|
|The University of Iowa College of Dentistry|
|Iowa City, Iowa, United States, 52242-1010|
|Principal Investigator:||Clark Stanford, DDS, PhD||The University of Iowa|