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
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|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|
|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|
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
- 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
- RPD abutment tooth loss [ Time Frame: 60 months ]Loss of any RPD abutment tooth for any reason whether crowned or otherwise.
- 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
- Tooth loss [ Time Frame: 60 months ]Loss of any nonabutment tooth in either arch for any reason
- Caries [ Time Frame: 60 months ]Dental caries involving any tooth in either arch
- Periodontal disease [ Time Frame: 60 months ]Change in clinical attachment level involving any tooth in either arch compared to baseline presentation.
- Periodontal disease [ Time Frame: 60 months ]Increase or decrease in mobility involving any tooth in either arch compared to baseline presentation.
- Periodontal disease [ Time Frame: 60 months ]Onset of fremitus involving any tooth in either arch relative to baseline presentation.
- Periodontal disease [ Time Frame: 60 months ]Change in furcation classification involving any molar in either arch relative to baseline presentation..
- Periodontal disease [ Time Frame: 60 months ]Change in overall score for bleeding index compared to baseline presentation.
- Periodontal disease [ Time Frame: 60 months ]Change in overall score for plaque index compared to baseline presentation.
- Abutment tooth vitality [ Time Frame: 60 months ]Loss of vitality of any abutment tooth, crowned or otherwise
- Patient satisfaction and quality of life [ Time Frame: 60 months ]Change in patient satisfaction and quality of life, measured using the OHIP-14 questionnaire
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
|Contact: Vaughan J Hoefler, DDS, MBA||(907)firstname.lastname@example.org|
|Contact: Hiroko Nagaoka, DDS, MS||(859)email@example.com|
|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 firstname.lastname@example.org|
|Contact: Hiroko Nagaoka, DDS, MS (859)257-2101 email@example.com|