Outcome Evaluation of Ceramic Crowns Using Two Different Dental Cements

NCT00591942 | Completed Results

• 1 other identifier: 200408065
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of Post-operative Pain (Yes/no)

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

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

Study Arms (2)

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.

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.

Device: Full ceramic crowns or 3-unit fixed partial dentures.

Interventions

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.

MultiLink dental cement; VivaGlass dental cement

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Clark Stanford: lead

Study Sites (1)

The University of Iowa College of Dentistry

Iowa City, Iowa, 52242-1010, United States

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Results Point of Contact

• Title: Dr. Clark Stanford
• Organization: University of Iowa

Clark-Stanford@uiowa.edu

319-335-7381

Study Officials

• Clark Stanford, DDS, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subject unaware of the dental cement used on which crown or retainer
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Dean for Research & Professor

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

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 11, 2008
• Study Start: November 1, 2004
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: March 8, 2018
• Results First Posted: March 8, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)