NCT03067337

Evaluation Between Zirconia and Stainless Steel Crowns

Clinical Evaluation Between Zirconia Crowns and Stainless Steel Crowns in Primary Molars Teeth

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: King Abdulaziz University · Academic / Other
• Sex: All
• Age: 4 Years – 8 Years
• Healthy volunteers: Accepted

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%).

Conditions

• Tooth Diseases

Interventions

Type	Name	Description
DEVICE	Stainless Steel Crown (Group A)	Full coverage restoration for multi-surface carious teeth
DEVICE	NuSmile Zirconia Crowns (Group B)	Full coverage restoration for multi-surface carious teeth

Timeline

• Start date: 2015-08-30
• Primary completion: 2016-08-30
• Completion: 2016-12-30
• First posted: 2017-03-01
• Last updated: 2017-03-01

Regulatory

• FDA-regulated device study