Evaluation Between Zirconia and Stainless Steel Crowns

NCT03067337 | Completed FDA Device

• 1 other identifier: Zirconia and SSC
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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%).

Conditions

Tooth Diseases

Keywords

Stainless Steel Crowns; Zirconia Crowns; Aesthetic restorations

Outcome Measures

Primary Outcomes (3)

• 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 \[Löe, 1967\].

  3-month follow-up

• 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 \[Löe,1967\].

  3-month follow-up

• Restoration failure

  This was clinically evaluated with visual assessment of the restoration, according to the US Public Health Service "USPHS", Alpha criteria rating system \[Ryge, 1980\].

  3-month follow-up

Study Arms (2)

Stainless Steel Crowns (Group A)

EXPERIMENTAL

Groups that received Stainless Steel Crowns

Device: Stainless Steel Crown (Group A)

Zirconia crowns (Group B)

EXPERIMENTAL

Groups that received Zirconia crowns

Device: NuSmile Zirconia Crowns (Group B)

Interventions

Stainless Steel Crown (Group A) DEVICE

Full coverage restoration for multi-surface carious teeth

Also known as: Stainless Steel Crown

Stainless Steel Crowns (Group A)

NuSmile Zirconia Crowns (Group B) DEVICE

Full coverage restoration for multi-surface carious teeth

Also known as: Zirconia crowns

Zirconia crowns (Group B)

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• King Abdulaziz University: lead

MeSH Terms

Conditions

Tooth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: January 22, 2017
• First Posted: March 1, 2017
• Study Start: August 30, 2015
• Primary Completion: August 30, 2016
• Study Completion: December 30, 2016
• Last Updated: March 1, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share