Sensitivity to Dental CementsNCT00591942
Outcome Evaluation of Ceramic Crowns Using Two Different Dental Cements
A study testing Full ceramic crowns or 3-unit fixed partial dentures. in people with Sensitivity to Dental Cements and Dental Crowns, run by Clark Stanford at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sensitivity to Dental Cements, Dental Crowns, Dental Three-unit Bridges
- What is being tested?
- Full ceramic crowns or 3-unit fixed partial dentures.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Dec 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Iowa College of Dentistry
Iowa City, Iowa, 52242-1010
About this study
Official title: Outcome Evaluation of All Ceramic Crowns and Fixed Partial Dentures Bonded With 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.
Read the 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.
- Being tested
- Full ceramic crowns or 3-unit fixed partial dentures.
- Keywords
- dental cement, ceramic crowns, three-unit bridges, sensitivity
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| VivaGlass dental cement | Active comparator | 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. Receives: Device: Full ceramic crowns or 3-unit fixed partial dentures. |
| MultiLink dental cement | Active comparator | 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. Receives: Device: Full ceramic crowns or 3-unit fixed partial dentures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Post-operative Pain (Yes/no)
Scores reported are subjects reporting any pain (yes/no)
Measured: Outcome is measured: 24 hrs., 7 days, and 6, 12, 18 and 24 months following seating of the restorations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startNov 2004
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sensitivity to Dental CementsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 2 crowns per subject or one dental bridge with two retainer crowns for a total of 72 Teeth.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clark Stanford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Clark Stanford, University of Iowa
- Investigators
- Clark Stanford, DDS, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00591942
- Sponsor's protocol ID
- 200408065
- Status last verified
- Feb 2018
- First submitted
- 26 Dec 2007
- Last updated
- 8 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: IPD data is tied to Hippa identifiers and therefore cannot be released
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Evaluation of All Ceramic Crowns and Fixed Partial Dentures Bonded With Two Different Dental Cements.
- ClinicalTrials.gov ID
- NCT00591942
- Acronym / sponsor ID
- 200408065
- Keywords
- dental cement, ceramic crowns, three-unit bridges, sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Clark StanfordUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 11 Jan 2008 (estimated)
- Results
- Posted 8 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 crowns per subject or one dental bridge with two retainer crowns for a total of 72 Teeth.
| Arm | Type | Receives |
|---|---|---|
| VivaGlass dental cement | Active comparator | Device: Full ceramic crowns or 3-unit fixed partial dentures.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. |
| MultiLink dental cement | Active comparator | Device: Full ceramic crowns or 3-unit fixed partial dentures.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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full 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. | Device | MultiLink dental cement, VivaGlass dental cement |
Primary outcome
Incidence of Post-operative Pain (Yes/no)
Time frame: Outcome is measured: 24 hrs., 7 days, and 6, 12, 18 and 24 months following seating of the restorations
Scores reported are subjects reporting any pain (yes/no)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. IPD data is tied to Hippa identifiers and therefore cannot be released
Related trials for Sensitivity to Dental Cements
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clark Stanford, DDS, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full ceramic crowns or 3-unit fixed partial dentures. in people with Sensitivity to Dental Cements and Dental Crowns, run by Clark Stanford at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Post-operative Pain (Yes/no) (time frame: Outcome is measured: 24 hrs., 7 days, and 6, 12, 18 and 24 months following seating of the restorations). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2018.