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Evaluation Between Zirconia and Stainless Steel Crowns

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03067337
Enrollment
120
Registered
2017-03-01
Start date
2015-08-30
Completion date
2016-12-30
Last updated
2017-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth Diseases

Keywords

Stainless Steel Crowns, Zirconia Crowns, Aesthetic restorations

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%).

Interventions

DEVICEStainless Steel Crown (Group A)

Full coverage restoration for multi-surface carious teeth

DEVICENuSmile Zirconia Crowns (Group B)

Full coverage restoration for multi-surface carious teeth

Sponsors

King Abdulaziz University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Gingival health3-month follow-upThis 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 index3-month follow-upThis 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 failure3-month follow-upThis was clinically evaluated with visual assessment of the restoration, according to the US Public Health Service USPHS, Alpha criteria rating system \[Ryge, 1980\].

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026