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Removable Partial Denture Abutments Restored With Monolithic Zirconia Crowns

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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

  Show Detailed Description

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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

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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
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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
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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:

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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

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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