Trial Outcomes & Findings for Removable Partial Denture Abutments Restored With Monolithic Zirconia Crowns (NCT NCT03283709)

NCT ID: NCT03283709

Last Updated: 2020-03-13

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 1 participants
• Primary outcome timeframe: 60 months
• Results posted on: 2020-03-13

Participant Flow

Participant milestones

Measure	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 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 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
Overall Study STARTED	0	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	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 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 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
Overall Study trial terminated	0	1

Baseline Characteristics

Removable Partial Denture Abutments Restored With Monolithic Zirconia Crowns

Baseline characteristics by cohort

Measure	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 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 n=1 Participants 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 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	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	—	1 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 60 months

Population: The single enrolled participant did not complete the intervention; thus, no data were generated.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 60 months

Population: The single enrolled participant did not complete the intervention; thus, no data were generated.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 60 months

Population: The single enrolled participant did not complete the intervention; thus, no data were generated.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 60 months

Population: The single enrolled participant did not complete the intervention; thus, no data were generated.

Loss of any nonabutment tooth in either arch for any reason

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 60 months

Population: The single enrolled participant did not complete the intervention; thus, no data were generated.

Dental caries involving any tooth in either arch

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 60 months

Population: The single enrolled participant did not complete the intervention; thus, no data were generated.

Change in clinical attachment level involving any tooth in either arch compared to baseline presentation.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 60 months

Population: The single enrolled participant did not complete the intervention; thus, no data were generated.

Increase or decrease in mobility involving any tooth in either arch compared to baseline presentation.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 60 months

Population: The single enrolled participant did not complete the intervention; thus, no data were generated.

Onset of fremitus involving any tooth in either arch relative to baseline presentation.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 60 months

Population: The single enrolled participant did not complete the intervention; thus, no data were generated.

Change in furcation classification involving any molar in either arch relative to baseline presentation..

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 60 months

Population: The single enrolled participant did not complete the intervention; thus, no data were generated.

Change in overall score for bleeding index compared to baseline presentation.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 60 months

Population: The single enrolled participant did not complete the intervention; thus, no data were generated.

Change in overall score for plaque index compared to baseline presentation.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 60 months

Population: The single enrolled participant did not complete the intervention; thus, no data were generated.

Loss of vitality of any abutment tooth, crowned or otherwise

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 60 months

Population: The single enrolled participant did not complete the intervention; thus, no data were generated.

Change in patient satisfaction and quality of life, measured using the OHIP-14 questionnaire

Outcome measures

Outcome data not reported

Adverse Events

Full-contour Monolithic Zirconia Crowns

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Conventional Abutment Crowns

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Hiroko Nagaoka

University of Kentucky

Phone: 859-257-2101

Email: h.nagaoka@uky.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place