Evaluation Between Zirconia and Stainless Steel Crowns

Study Overview
=================
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%).

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

Conditions
-----------------
Tooth Diseases

Intervention / Treatment
-----------------
* Device: Stainless Steel Crown (Group A)
* Device: NuSmile Zirconia Crowns (Group B)


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 8 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stainless Steel Crowns (Group A)<br>Groups that received Stainless Steel Crowns | Device: Stainless Steel Crown (Group A)<br>* Full coverage restoration for multi-surface carious teeth<br>* Other names: Stainless Steel Crown;|
| Experimental: Zirconia crowns (Group B)<br>Groups that received Zirconia crowns | Device: NuSmile Zirconia Crowns (Group B)<br>* Full coverage restoration for multi-surface carious teeth<br>* Other names: Zirconia crowns;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stainless Steel Crowns, Zirconia Crowns, Aesthetic restorations