Evaluation Between Zirconia and Stainless Steel Crowns
Primary Purpose
Tooth Diseases
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Stainless Steel Crown (Group A)
NuSmile Zirconia Crowns (Group B)
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Diseases focused on measuring Stainless Steel Crowns, Zirconia Crowns, Aesthetic restorations
Eligibility Criteria
Inclusion Criteria:
- Age group of 4-8 years
- Free of any systemic disease
- Cooperative patient
- At least two matched bilateral carious primary molars
- Minimal of two surfaces of caries in the targeted tooth
- Written consent obtained from the parent/guardian
Exclusion Criteria:
- Any subject that does not fall under the inclusion criteria were excluded.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Stainless Steel Crowns (Group A)
Zirconia crowns (Group B)
Arm Description
Groups that received Stainless Steel Crowns
Groups that received Zirconia crowns
Outcomes
Primary Outcome Measures
Gingival health
This parameter was evaluated using a blunt periodontal probe (Double ended probe Williams 1-2-3-5-7-8-9-10 Goldman Fox Flat) according to the Löe and Silness gingival index [Löe, 1967].
Plaque index
This parameter was evaluated using a blunt periodontal probe (Double ended probe Williams 1-2-3-5-7-8-9-10 Goldman Fox Flat) according to the Löe and Silness gingival index [Löe,1967].
Restoration failure
This was clinically evaluated with visual assessment of the restoration, according to the US Public Health Service "USPHS", Alpha criteria rating system [Ryge, 1980].
Secondary Outcome Measures
Full Information
NCT ID
NCT03067337
First Posted
January 22, 2017
Last Updated
February 24, 2017
Sponsor
King Abdulaziz University
1. Study Identification
Unique Protocol Identification Number
NCT03067337
Brief Title
Evaluation Between Zirconia and Stainless Steel Crowns
Official Title
Clinical Evaluation Between Zirconia Crowns and Stainless Steel Crowns in Primary Molars Teeth
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 30, 2015 (Actual)
Primary Completion Date
August 30, 2016 (Actual)
Study Completion Date
December 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Abdulaziz University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Introduction and Research Problem:
The aim of this project is to evaluate and compare two full coronal restorations on primary posterior molars over a period of 3, 6 and 12 months in terms of restoration failure, marginal integrity, proximal contact, secondary caries, occlusion and gingival response. The restorations types are Stainless Steel Crowns (SSC) and NuSmile Zirconia Crowns (Nu/ZR).
Materials and Methods:
Children attending the King Abdulaziz University, Faculty of Dentistry (KAUFD) clinics who need restorations will be screened for inclusion criteria till 120 teeth are recruited (60 teeth for SSC restorations and 60 for Nu/ZR restorations). Split mouth technique will be used to ensure equalizing variables for both groups, each patient will have side restored with SSC and the opposite side will be restored with Nu/ZR crowns.
Randomization will be done using Statistical Package for the Social Sciences (SPSS) software version 20.0 (Armonk, New York; International Business Machines Corporation (IBM Corp) for each age group separately with a uniform random variable generation. A simple descriptive statistics will be used for analysis and a T-Tests with Wilcoxon Signed-Rank will be used. Level of significance will be set at (α = 0.05) and level of confidence at (95%).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Diseases
Keywords
Stainless Steel Crowns, Zirconia Crowns, Aesthetic restorations
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stainless Steel Crowns (Group A)
Arm Type
Experimental
Arm Description
Groups that received Stainless Steel Crowns
Arm Title
Zirconia crowns (Group B)
Arm Type
Experimental
Arm Description
Groups that received Zirconia crowns
Intervention Type
Device
Intervention Name(s)
Stainless Steel Crown (Group A)
Other Intervention Name(s)
Stainless Steel Crown
Intervention Description
Full coverage restoration for multi-surface carious teeth
Intervention Type
Device
Intervention Name(s)
NuSmile Zirconia Crowns (Group B)
Other Intervention Name(s)
Zirconia crowns
Intervention Description
Full coverage restoration for multi-surface carious teeth
Primary Outcome Measure Information:
Title
Gingival health
Description
This parameter was evaluated using a blunt periodontal probe (Double ended probe Williams 1-2-3-5-7-8-9-10 Goldman Fox Flat) according to the Löe and Silness gingival index [Löe, 1967].
Time Frame
3-month follow-up
Title
Plaque index
Description
This parameter was evaluated using a blunt periodontal probe (Double ended probe Williams 1-2-3-5-7-8-9-10 Goldman Fox Flat) according to the Löe and Silness gingival index [Löe,1967].
Time Frame
3-month follow-up
Title
Restoration failure
Description
This was clinically evaluated with visual assessment of the restoration, according to the US Public Health Service "USPHS", Alpha criteria rating system [Ryge, 1980].
Time Frame
3-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age group of 4-8 years
Free of any systemic disease
Cooperative patient
At least two matched bilateral carious primary molars
Minimal of two surfaces of caries in the targeted tooth
Written consent obtained from the parent/guardian
Exclusion Criteria:
Any subject that does not fall under the inclusion criteria were excluded.
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation Between Zirconia and Stainless Steel Crowns
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