Evaluation Between Zirconia and Stainless Steel Crowns

King Abdulaziz University

Status: Completed

Conditions: Tooth Diseases

Treatments: Device: Stainless Steel Crown (Group A); Device: NuSmile Zirconia Crowns (Group B)

Study type: Interventional

Funder types: Other

Identifiers

NCT03067337

Zirconia and SSC

Details and patient eligibility

About

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%).

Enrollment: 120 patients

Sex: All

Ages: 4 to 8 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

Stainless Steel Crowns (Group A)

Experimental group

Description:

Groups that received Stainless Steel Crowns

Treatment:

Device: Stainless Steel Crown (Group A)

Zirconia crowns (Group B)

Experimental group

Description:

Groups that received Zirconia crowns

Treatment:

Device: NuSmile Zirconia Crowns (Group B)