N/A
N=72
Outcome Evaluation of Ceramic Crowns Using Two Different Dental Cements
Sensitivity to Dental Cements · Dental Crowns · Dental Three-unit Bridges
Bottom Line
View on ClinicalTrials.gov: NCT00591942 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: Incidence of Post-operative Pain (Yes/no) — 1; 0; 1; 2 participants — p=0.5637
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Full ceramic crowns or 3-unit fixed partial dentures. (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Clark Stanford
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Post-operative Pain (Yes/no) |
1; 0; 1; 2; 3; 5 | 0.5637 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00591942). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.