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Outcome Evaluation of Ceramic Crowns Using Two Different Dental Cements

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00591942
Enrollment
36
Registered
2008-01-11
Start date
2004-11-30
Completion date
2009-12-31
Last updated
2018-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Crowns, Dental Three-unit Bridges, Sensitivity to Dental Cements

Keywords

dental cement, ceramic crowns, three-unit bridges, sensitivity

Brief 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.

Detailed description

Background and Significance: The development of porcelain crowns for the predictable restoration of teeth has been brought about by the development of bonding techniques to enamel and dentin with the use of multi-step total etch adhesive systems along with the evolution in small particle hybrid resin composites as adhesive luting agents. One of the most common post-operative concerns of patients following delivery of full coverage crowns and bridges is sensitivity to thermal conditions in the mouth (cold water, ice cream, etc.) (Goodacre, Bernal et al. 2003). In order to understand the biological basis for these materials it is important to understand the anatomy and neurophysiology of dentin. The following is adapted from a paper provided by Dr. Charles Cox (Professor, University of Alabama School of Dentistry) concerning dentin structure and mechanisms for reduction of dentin hypersensitivity . Dentin is a vital tissue, harder than bone but weaker than enamel with a physiological elasticity preventing tooth fracture. Dentin is approx. 74% mineral; the organic phase being approx. 26% type-1 collagen with small amounts of proteins and water. The collagen matrix is secreted as a biologically plastic material, which hardens by a variety of mechanisms. Normal dentin is composed of millions of tubules or canals, running from the pulpal wall to the Dentin-Enamel Junction (DEJ). The dimensions of these tubules or canals varies depending on the position within the dentin structure. For instance, tubule diameter at the DEJ is 0.06 µm, and 3.0 µm at the pulpal wall (approx. 60,000 tubules / mm2). Most tubules are filled with fluid, an odontoblast cell process, collagen, and occasional non-myelinated pulpal nerves coursing approx. 150 µm towards the DEJ (Ten Cate 1998). In normal (non-anesthetized) patients, Gysi (1900) reported that fluid distortion on the cavity floor caused sharp pain. Brännström et al. (1966, 1969, 1976, 1979, 1980, 1996) demonstrated dentin hypersensitivity (sharp pain) is the result of rapid fluid movement in the tubule complex, aggravated by aggressive air-drying. Physiological testing in various animal studies (Heyeraas 1985, Narhi 1983, 1985) confirmed the fluid pulsing or hydrodynamic mechanism (Brännström 1966) as the prime cause of sudden dentin pain. Physiologically, any rapid bi-directional fluid flow is the result of a sudden shift in tubule fluid from stimuli (i.e. cold or rapid airflow; Brännström 1996). Management of dentin hypersensitivity is only one part of a successful dental complete coverage restoration (dental crown or bridge). In evaluating the clinical service-life of porcelain crowns there are three aspects of the bonding environment that needs to be considered. These consist of the tooth preparation, the adhesive and the tooth or crown preparation and the fit of the porcelain restoration to the tooth preparation. All ceramic restorations need enamel and dentin reduction of at least 1.5 mm along with a smooth shoulder and avoidance of sharp edges to avoid crack formation on the intaglio surface, proper esthetics, physiological contours and strength of the final restoration.(Goodacre, Campagni et al. 2001) Dental preparation for full coverage restorations (1.5 to 2 mm clearance which often means 1.5 - 2 mm loss of tooth structure) are inherently non-conservative and with a reduced amount of remaining tooth structure there is an elevated risk of post-operative sensitivity. In today's society, having a dental restoration that provides minimal post-operative sensitivity is only part of the demand from patients. There is an increasing expectation for esthetic, life-like restorations that simulate if not replicate the natural tooth. This is complicated especially in patients with heavy occlusion or are missing teeth. The development of CAD/CAM milling technologies has laid the groundwork for use of high strength heat-pressed zirconia \[tetragonal zirconia polycrystals (TZP) a yttrium partially stabilized polycrystal structure\] as a supporting framework for supporting an esthetic, life-like Lucite-base veneering ceramic material to provide an all ceramic form of full coverage dental restorations for individual teeth or replacement of a single missing tooth with a 3-united fixed partial denture (dental bridge). The use of press porcelain crown technology has allowed the improvement of fit of refractory die porcelain crown fabrication relative to conventional Pt foil techniques and may lead to greater predictability and reduced microleakage (with enhanced service life of the dental restoration). The potential for an enhanced service life may depend on a combination of silination with a bifunctional bis-GMA primer and dual cured composite resin luting agent which may seal microcracks within the intaglio surface of the porcelain and a sufficient bond to tooth structure for a reasonable service life.

Interventions

DEVICEFull ceramic crowns or 3-unit fixed partial dentures.

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.

Sponsors

Clark Stanford
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Masking description

Subject unaware of the dental cement used on which crown or retainer

Intervention model description

2 crowns per subject or one dental bridge with two retainer crowns for a total of 72 Teeth.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Post-operative Pain (Yes/no)Outcome is measured: 24 hrs., 7 days, and 6, 12, 18 and 24 months following seating of the restorationsScores reported are subjects reporting any pain (yes/no)

Countries

United States

Participant flow

Recruitment details

Subjects needing a dental crown or dental bridge

Participants by arm

ArmCount
Group 1
Note only one group is listed since EACH subject received TWO crowns. AS cross-over design, ONE crown had the VivaGlass cement and the second crown (in the same subject) had the Multi-link cement.
36
Total36

Baseline characteristics

CharacteristicGroup 1
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
36 Participants
Age, Continuous56 years
STANDARD_DEVIATION 10
Region of Enrollment
United States
36 participants
Sex: Female, Male
Female
24 Participants
Sex: Female, Male
Male
12 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 360 / 36
other
Total, other adverse events
1 / 360 / 36
serious
Total, serious adverse events
0 / 360 / 36

Outcome results

Primary

Incidence of Post-operative Pain (Yes/no)

Scores reported are subjects reporting any pain (yes/no)

Time frame: Outcome is measured: 24 hrs., 7 days, and 6, 12, 18 and 24 months following seating of the restorations

ArmMeasureGroupValue (NUMBER)
Ivoclar Vivaglass CEM IC CementIncidence of Post-operative Pain (Yes/no)7 days3 participants
Ivoclar Vivaglass CEM IC CementIncidence of Post-operative Pain (Yes/no)12 months2 participants
Ivoclar Vivaglass CEM IC CementIncidence of Post-operative Pain (Yes/no)24 hours1 participants
Ivoclar Vivaglass CEM IC CementIncidence of Post-operative Pain (Yes/no)18 months3 participants
Ivoclar Vivaglass CEM IC CementIncidence of Post-operative Pain (Yes/no)6 month4 participants
Ivoclar Vivaglass CEM IC CementIncidence of Post-operative Pain (Yes/no)24 months3 participants
Ivoclar Vivaglass CEM IC CementIncidence of Post-operative Pain (Yes/no)0 Hour1 participants
Ivoclar/Vivadent Composite Resin CementIncidence of Post-operative Pain (Yes/no)24 months3 participants
Ivoclar/Vivadent Composite Resin CementIncidence of Post-operative Pain (Yes/no)0 Hour0 participants
Ivoclar/Vivadent Composite Resin CementIncidence of Post-operative Pain (Yes/no)24 hours2 participants
Ivoclar/Vivadent Composite Resin CementIncidence of Post-operative Pain (Yes/no)7 days5 participants
Ivoclar/Vivadent Composite Resin CementIncidence of Post-operative Pain (Yes/no)6 month3 participants
Ivoclar/Vivadent Composite Resin CementIncidence of Post-operative Pain (Yes/no)12 months3 participants
Ivoclar/Vivadent Composite Resin CementIncidence of Post-operative Pain (Yes/no)18 months3 participants
p-value: 0.5637Chi-squared

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026