Success of Zirconia and Stainless Steel Crowns for Permanent Molars
Primary Purpose
Caries Active, Dentin, Carious
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
zirconia crowns
stainless steel crowns
Sponsored by
About this trial
This is an interventional treatment trial for Caries Active focused on measuring zirconia crowns, stainless steel crowns, dental caries
Eligibility Criteria
Inclusion Criteria:
- Patients and parent of the patients who accept to participate and sign the informed consent
- Patients who have at least two permanent molars with caries that require crown restoration
- Patients that have good cooperation to the procedure
Exclusion Criteria:
- Patients and parent of the patients who don't accept to participate and sign the informed consent
- Teeth that doesn't have opposing permanent molars
- Patients who have bruxism or deep-bite
- Patient who are allergic to nickel
Sites / Locations
- Hacettepe University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
zirconia crowns
stainless steel crowns
Arm Description
esthetic crowns for capping permanent molars with caries
stainless steel crowns for capping permanent molars with caries
Outcomes
Primary Outcome Measures
Number of zirconia and stainless steel crowns that showed successful retention over two years
Long-term clinical success of zirconia and stainless steel crowns placed on permanent molars
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05049694
Brief Title
Success of Zirconia and Stainless Steel Crowns for Permanent Molars
Official Title
Clinical and Radiographic Performance of Preformed Zirconia Crowns and Stainless-Steel Crowns in Permanent First Molars: 18-Month Results of a Prospective, Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate and compare the clinical and radiographic performance of zirconia and stainless steel crowns on permanent molar
Detailed Description
Zirconia and stainless steel crowns will be placed on at least two permanent molars, in a split mouth design. 100 patients will be included in the study. The teeth will be randomized into two groups according to the crown type.
Group 1: Zirconia crown 2: Stainless steel crown. Plaque index, gingival index, crown retention, presence of restoration failure, gingival margin extension and pulpal health of the teeth will be clinically evaluated at baseline and 1., 6., 12., 18., 24. months. The restorations will be evaluated radiographically at 6., 12. and 18. months. Intra-oral photos will be taken directly after treatment and at control appointments.
The data will be analysed statistically using Fisher's Exact Test and pearson's chi-square test; and Log-rank and the Kaplan-Meier will be used to estimate survival percentages.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries Active, Dentin, Carious
Keywords
zirconia crowns, stainless steel crowns, dental caries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
zirconia crowns
Arm Type
Experimental
Arm Description
esthetic crowns for capping permanent molars with caries
Arm Title
stainless steel crowns
Arm Type
Experimental
Arm Description
stainless steel crowns for capping permanent molars with caries
Intervention Type
Device
Intervention Name(s)
zirconia crowns
Intervention Description
esthetic crowns for capping permanent molars with caries
Intervention Type
Device
Intervention Name(s)
stainless steel crowns
Intervention Description
stainless steel crowns for capping permanent molars with caries
Primary Outcome Measure Information:
Title
Number of zirconia and stainless steel crowns that showed successful retention over two years
Description
Long-term clinical success of zirconia and stainless steel crowns placed on permanent molars
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients and parent of the patients who accept to participate and sign the informed consent
Patients who have at least two permanent molars with caries that require crown restoration
Patients that have good cooperation to the procedure
Exclusion Criteria:
Patients and parent of the patients who don't accept to participate and sign the informed consent
Teeth that doesn't have opposing permanent molars
Patients who have bruxism or deep-bite
Patient who are allergic to nickel
Facility Information:
Facility Name
Hacettepe University
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
12. IPD Sharing Statement
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Success of Zirconia and Stainless Steel Crowns for Permanent Molars
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