Evaluation Between Zirconia and Stainless Steel Crowns

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%).

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Key information

Conditions

Tooth Diseases Stomatognathic Diseases

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stainless Steel Crown (Group A)

Device

Full coverage restoration for multi-surface carious teeth

Other names: Stainless Steel Crown

NuSmile Zirconia Crowns (Group B)

Device

Full coverage restoration for multi-surface carious teeth

Other names: Zirconia crowns

Primary outcomes

Gingival health

Time frame: 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].
Plaque index

Time frame: 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

Time frame: 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].

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Mar 1, 2017
Registry last updated: Mar 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed