Evaluation Between Zirconia and Stainless Steel Crowns

Not Applicable

Completed

• Conditions: Tooth Diseases
• Interventions: Device: NuSmile Zirconia Crowns (Group B); Device: Stainless Steel Crown (Group A)

• Registration Number: NCT03067337
• Lead Sponsor: 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%).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-30
• Primary Completion: 2016-08-30
• Study Completion: 2016-12-30
• Study First Submitted: 2017-01-22
• Status Verified: 2017-02
• Study First Submitted QC: 2017-02-24
• Last Update Submitted: 2017-02-24
• Study First Posted: 2017-03-01
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zirconia crowns (Group B)	NuSmile Zirconia Crowns (Group B)	Groups that received Zirconia crowns
Stainless Steel Crowns (Group A)	Stainless Steel Crown (Group A)	Groups that received Stainless Steel Crowns

Primary Outcome Measures

Name	Time	Method
Gingival health	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 \[Löe, 1967\].
Restoration failure	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 \[Ryge, 1980\].
Plaque index	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 \[Löe,1967\].