Removable Partial Denture Abutments Restored With Monolithic Zirconia Crowns

NCT03283709 | Terminated Results FDA Device

• 1 other identifier: 17-0511-F1V
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Crowns; Denture

Outcome Measures

Primary Outcomes (3)

• Need to Replace Crown on RPD Abutment Tooth

  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

  60 months

• RPD Abutment Tooth Loss

  Loss of any RPD abutment tooth for any reason whether crowned or otherwise.

  60 months

• RPD Failure

  Any technical or biologic complication resulting in loss of service of RPD. This includes loss of RPD as well as dissatisfaction and nonacceptance

  60 months

Secondary Outcomes (10)

• Tooth Loss

  60 months

• Caries

  60 months

• Periodontal Disease

  60 months

• Periodontal Disease

  60 months

• Periodontal Disease

  60 months

Study Arms (2)

Full-contour monolithic Zirconia crowns

EXPERIMENTAL

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

Conventional abutment crowns

OTHER

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

Interventions

Full-contour monolithic zirconia abutment crowns DEVICE

Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from monolithic multi-layered zirconia

Full-contour monolithic Zirconia crowns

Conventional abutment crowns DEVICE

Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from noble or high noble metals, veneered with feldspathic porcelain

Conventional abutment crowns

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hiroko Nagaoka: lead

Study Sites (1)

University of Kentucky College of Dentistry

Lexington, Kentucky, 40536-0297, United States

Location

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Results Point of Contact

• Title: Hiroko Nagaoka
• Organization: University of Kentucky

h.nagaoka@uky.edu

859-257-2101

Study Officials

• Vaughan Hoefler, DDS, MBA

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 11, 2017
• First Posted: September 14, 2017
• Study Start: December 1, 2017
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: March 13, 2020
• Results First Posted: March 13, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)