Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 27 of 120 for:    ZIRCONIUM

Removable Partial Denture Abutments Restored With Monolithic Zirconia Crowns

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03283709
Recruitment Status : Recruiting
First Posted : September 14, 2017
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Vaughan Hoefler, University of Kentucky

Brief Summary:

The purpose of this study is to investigate the use of an all-ceramic dental crown material to restore the abutment teeth of partially-edentulous patients who need removable partial dentures (RPD). The outcomes of the treatment group (all-ceramic crowns) will be compared to a similarly-treated control group whose RPD abutment teeth are restored using conventional metal and metal-ceramic crowns. Primary outcomes of interest include crown survival, abutment tooth survival and RPD survival.The null hypothesis is that at the conclusion of the study there will be no differences in outcomes between the two groups.

All dental treatment, including dental hygiene and periodontal care, fillings, crowns and RPD fabrication will be provided by predoctoral dental students in the University of Kentucky College of Dentistry student clinics. Students treating the subjects will be supervised by licensed, technique-calibrated faculty specialists. Following the completion of dental treatment, enrolled subjects will be clinically re-evaluated by investigators at 6 months, and at annual intervals thereafter for 5 years following RPD delivery.


Condition or disease Intervention/treatment Phase
Crowns Denture Device: Full-contour monolithic zirconia abutment crowns Device: Conventional abutment crowns Not Applicable

  Hide Detailed Description

Detailed Description:

This study will investigate the use of highly esthetic, second and third generation multi-layer zirconia crown materials to restore removable partial denture abutment teeth. All performed treatment will be the standard of care and to the usual and customary standards used in United states dental clinics for crown and RPD procedures. Treatment subjects will have RPD abutment teeth restored with either Noritake Katana STML (anterior teeth) or HTML (premolars and molars) zirconia crowns, and periodically evaluated for 60 months following RPD delivery. Outcomes will be compared to a similarly treated control group restored with metal, metal-ceramic, or a combination of metal and metal-ceramic crowns.

Following informed consent, subjects will be randomly assigned using an internet program (https://www.randomizer.org/) to either a treatment (zirconia abutment tooth crown) or control (metal or metal-ceramic abutment tooth crown) group. Using information from the oral examination, articulated diagnostic casts will be evaluated , the RPD design confirmed, and the need for a crown on one or more abutment teeth verified. Enrolled subjects will be given oral hygiene instruction at the beginning of the study. They will also be instructed to brush their teeth twice daily using an OTC fluoride dentifrice of their choice. They will also be asked to use a 0.05% NaF oral rinse for 1 minute daily.

Abutment teeth must be in function with the opposing arch and vital at the beginning of the study. Vitality will be be determined using a synthesis of history, percussion, palpation and pulp testing. Pulp tests will be conducted using cold and an EPT, and the facial, lingual and occlusal (incisal) surfaces of all abutment teeth will be tested for responsiveness. If abutment tooth vitality is confirmed, teeth requiring surveyed crowns will be prepared and restored using standardized clinical and laboratory guidelines.

Abutment teeth restored with metal and zirconia crowns will be prepared and restored using the following clinical and laboratory guidelines. The margin will be a circumferential chamfer prepared to a depth of 0.5 mm with a rounded internal line angle and a 90° cavosurface exit angle. Margin height will be at or slightly coronal to the free gingival margin where possible. Axial surfaces will be prepared with a total occlusal convergence of >6° but not to exceed 20°. Incisal and facial surfaces will be reduced 0.7-1.0 mm. Functional surfaces will be reduced to 1.0 mm of opposing tooth clearance with the exception of under rest seats, where opposing tooth clearance will be 2.0 mm. At completion, the prepared tooth should have a height to base ratio of 0.4. If inadequate retention and resistance form is identified following preparation of axial walls, supplementary grooves will be added, the number and location of which are at the discretion of the investigator. Final impressions will be made using PVS in a custom tray (Extrude) and poured in type V dental stone (Jadestone). Following fabrication, the working cast will be articulated, tripoded, and the die(s) sectioned, trimmed and scanned (3Shape D2000 laboratory scanner or equivalent). The crown(s) will be waxed to full contour. Rest seats, undercuts and guide planes will then be developed in wax. Once the waxup has been surveyed and finalized, it will be secured to the scanning platform and a new scan performed with the waxup in place. The data file with the die scan will be merged with the file that contains the waxup. The merged file will then be transmitted to a designated production facility where the zirconia crown(s) will be milled. Canines will be milled using Noritake Katana STML zirconia and premolars and molars will be milled using Noritake Katana HTML zirconia. Once the crown(s) are returned and the margins, contacts, occlusion and contours clinically verified, they will be luted using a self-adhesive resin-based cement (RelyX Unicem 2).

Porcelain-fused-to-metal (PFM) crowns will be prepared and restored using a standard protocol utilizing the following guidelines. Posterior crowns will have metal occlusal surfaces with the porcelain-metal junction on the occlusal surface at half the distance between the central groove and the buccal cusp tip. Mesial, distal and lingual surfaces will be in metal, and the crown will have a disappearing metal margin on the facial surface. The facial preparation from mesiofacial to distofacial line angles will be a heavy chamfer or modified shoulder 1.0-1.2 mm in depth with a rounded internal line angle and a 90° cavosurface exit angle. Mesial, distal and lingual chamfer margins will be prepared to a horizontal depth of 0.5 mm. Facial margin height will be at or slightly apical to the free gingival margin. Mesial, distal and lingual margin height will be at or slightly coronal to the free gingival margin if possible. Functional surfaces will be prepared with opposing tooth clearance of 1.5 mm with the exception of under rest seats where opposing tooth clearance will be 2.0 mm. Nonfunctional cusp reduction will be 1.0 mm. Final impressions will be made using PVS (Extrude) in a custom tray and poured in type V dental stone (Jadestone). Following working cast fabrication it will be articulated, tripoded, and the die(s) prepared for conventional laboratory crown fabrication. Conventional (all-metal and PFM) surveyed crowns will be fabricated using noble and high-noble casting alloys and PFM crowns will use feldspathic porcelain as a veneering ceramic. Once the crown(s) are returned and the margins, contacts, occlusion and contours clinically verified, they will be luted using a self-adhesive resin-based cement (RelyX Unicem 2).

Qualifying RPD designs may be Kennedy class I-IV with up to two modification spaces, and will be designed using a standardized protocol. Maxillary major connectors may consist of a complete palatal plate, modified palatal plate, anterior-posterior palatal strap or palatal strap. Mandibular major connectors will consist of either a lingual plate or a lingual bar. Frameworks will be fabricated from nickel-chrome alloy (Ticonium), the denture bases acrylic resin (Lucitone 199), and artificial teeth will be DENTSPLY Trubyte IPN Portrait. To meet the definition of an RPD abutment tooth it must host a direct retainer consisting of an occlusal or cingulum rest, a proximal plate and a retentive clasp. Reciprocation must be provided in the form of a plate, reciprocating clasp or minor connector and rest. The plan for occlusion will be based upon the number and distribution of remaining natural teeth. If an arch opposing the RPD is edentulous and restored by a removable complete denture, then natural and artificial teeth will be arranged in bilateral balance. If anterior guidance is present on natural teeth in both arches it will be preserved so that artificial RPD teeth contact opposing teeth in maximum intercuspation only.

Clinical assessments, procedures and annual examinations will be performed in the University of Kentucky College of Dentistry second, third, and fourth floor student clinics. Clinical procedures will be performed by third and fourth year dental students, and clinical supervision for these procedures will be provided by licensed, calibrated investigators.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A prospective, randomized controlled trial comparing treatment outcomes for partial edentulism using two restorative materials. A convenience sample of study participants will be randomly assigned to either a treatment group or a control group.
Masking: None (Open Label)
Masking Description: No masking
Primary Purpose: Treatment
Official Title: Removable Partial Denture Abutments Restored With Monolithic Zirconia Crowns: A Randomized Controlled Trial
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dentures
Drug Information available for: Zirconium

Arm Intervention/treatment
Experimental: Full-contour monolithic Zirconia crowns
If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from multi-layered monolithic zirconia
Device: Full-contour monolithic zirconia abutment crowns
Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from monolithic multi-layered zirconia

Conventional abutment crowns
If participants assigned to this arm are in need of surveyed crowns on RPD abutment teeth they will be fabricated from type III gold or high-noble metal veneered with feldspathic porcelain
Device: Conventional abutment crowns
Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from noble or high noble metals, veneered with feldspathic porcelain




Primary Outcome Measures :
  1. Need to replace crown on RPD abutment tooth [ Time Frame: 60 months ]
    This is a collective measure reporting need to replace an abutment tooth crown for any reason. This includes repeated adhesive failure at crown interface due to inadequate retention/resistance form in the abutment tooth preparation, catastrophic fracture of monolithic or veneering crown ceramic necessitating crown replacement, primary or secondary caries involving crowned abutment tooth necessitating crown replacement

  2. RPD abutment tooth loss [ Time Frame: 60 months ]
    Loss of any RPD abutment tooth for any reason whether crowned or otherwise.

  3. RPD failure [ Time Frame: 60 months ]
    Any technical or biologic complication resulting in loss of service of RPD. This includes loss of RPD as well as dissatisfaction and nonacceptance


Secondary Outcome Measures :
  1. Tooth loss [ Time Frame: 60 months ]
    Loss of any nonabutment tooth in either arch for any reason

  2. Caries [ Time Frame: 60 months ]
    Dental caries involving any tooth in either arch

  3. Periodontal disease [ Time Frame: 60 months ]
    Change in clinical attachment level involving any tooth in either arch compared to baseline presentation.

  4. Periodontal disease [ Time Frame: 60 months ]
    Increase or decrease in mobility involving any tooth in either arch compared to baseline presentation.

  5. Periodontal disease [ Time Frame: 60 months ]
    Onset of fremitus involving any tooth in either arch relative to baseline presentation.

  6. Periodontal disease [ Time Frame: 60 months ]
    Change in furcation classification involving any molar in either arch relative to baseline presentation..

  7. Periodontal disease [ Time Frame: 60 months ]
    Change in overall score for bleeding index compared to baseline presentation.

  8. Periodontal disease [ Time Frame: 60 months ]
    Change in overall score for plaque index compared to baseline presentation.

  9. Abutment tooth vitality [ Time Frame: 60 months ]
    Loss of vitality of any abutment tooth, crowned or otherwise

  10. Patient satisfaction and quality of life [ Time Frame: 60 months ]
    Change in patient satisfaction and quality of life, measured using the OHIP-14 questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Partially edentulous and treatment planned for an RPD
  • Requires at least 1 surveyed crown on an abutment tooth
  • Abutment teeth and RPD in function with opposing arch
  • Abutment teeth vital at time of study enrollment
  • English literacy, cognitively capable of understanding study and consent documents
  • Cognitively and functionally capable of performing prosthesis and oral self-care

Exclusion Criteria:

  • Any chronic or degenerative condition which impairs consent capability
  • Any cognitive or motor condition which impairs ability to follow instructions or perform oral self-care
  • Healthy enough to tolerate planned dental procedures without premedication
  • Chronic infectious disease
  • COPD
  • Renal insufficiency
  • Autoimmune or chronic inflammatory disorders
  • Unstable asthma or diabetes
  • Unstable hypertension

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03283709


Contacts
Layout table for location contacts
Contact: Vaughan J Hoefler, DDS, MBA (907)978-9199 vaughan.hoefler@uky.edu
Contact: Hiroko Nagaoka, DDS, MS (859)257-2101 h.nagaoka@uky.edu

Locations
Layout table for location information
United States, Kentucky
University of Kentucky College of Dentistry Recruiting
Lexington, Kentucky, United States, 40536-0297
Contact: Vaughan J Hoefler, DDS, MBA    907-978-9199    vaughan.hoefler@uky.edu   
Contact: Hiroko Nagaoka, DDS, MS    (859)257-2101    h.nagaoka@uky.edu   
Sponsors and Collaborators
University of Kentucky

Publications:

Layout table for additonal information
Responsible Party: Vaughan Hoefler, Assistant Professor, University of Kentucky College of Dentistry Department of Oral Health Practice Division of Prosthodontics, University of Kentucky
ClinicalTrials.gov Identifier: NCT03283709     History of Changes
Other Study ID Numbers: 17-0511-F1V
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes