AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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

Other trials in United States

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 groups in NCT00591942
Study groupRoleWhat they receive
VivaGlass dental cementActive comparator36 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 cementActive comparator36 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.

  1. 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.

  1. First posted11 Jan 2008 (estimated)
  2. Study startNov 2004
  3. Primary completionDec 2009
  4. Study completionDec 2009

Resources

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)
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
Data monitoring committee
No
Individual data sharing
No: IPD data is tied to Hippa identifiers and therefore cannot be released

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in