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Trial record 6 of 119 for:    ZIRCONIUM

Evaluation Between Zirconia and Stainless Steel Crowns

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ClinicalTrials.gov Identifier: NCT03067337
Recruitment Status : Completed
First Posted : March 1, 2017
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Bashaer S. Abdulhadi, King Abdulaziz University

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%).


Condition or disease Intervention/treatment Phase
Tooth Diseases Device: Stainless Steel Crown (Group A) Device: NuSmile Zirconia Crowns (Group B) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation Between Zirconia Crowns and Stainless Steel Crowns in Primary Molars Teeth
Actual Study Start Date : August 30, 2015
Actual Primary Completion Date : August 30, 2016
Actual Study Completion Date : December 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Disorders
Drug Information available for: Zirconium

Arm Intervention/treatment
Experimental: Stainless Steel Crowns (Group A)
Groups that received Stainless Steel Crowns
Device: Stainless Steel Crown (Group A)
Full coverage restoration for multi-surface carious teeth
Other Name: Stainless Steel Crown

Experimental: Zirconia crowns (Group B)
Groups that received Zirconia crowns
Device: NuSmile Zirconia Crowns (Group B)
Full coverage restoration for multi-surface carious teeth
Other Name: Zirconia crowns




Primary Outcome Measures :
  1. Gingival health [ Time Frame: 3-month follow-up ]
    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].

  2. Plaque index [ Time Frame: 3-month follow-up ]
    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].

  3. Restoration failure [ Time Frame: 3-month follow-up ]
    This was clinically evaluated with visual assessment of the restoration, according to the US Public Health Service "USPHS", Alpha criteria rating system [Ryge, 1980].



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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Responsible Party: Bashaer S. Abdulhadi, PhD Student, King Abdulaziz University
ClinicalTrials.gov Identifier: NCT03067337     History of Changes
Other Study ID Numbers: Zirconia and SSC
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Bashaer S. Abdulhadi, King Abdulaziz University:
Stainless Steel Crowns
Zirconia Crowns
Aesthetic restorations
Additional relevant MeSH terms:
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Tooth Diseases
Stomatognathic Diseases