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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
King Abdulaziz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Diseases focused on measuring Stainless Steel Crowns, Zirconia Crowns, Aesthetic restorations

Eligibility Criteria

4 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    January 22, 2017
    Last Updated
    February 24, 2017
    Sponsor
    King Abdulaziz University
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    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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