Evaluation Between Zirconia and Stainless Steel Crowns

Tooth Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03067337
• Other study ID #: Zirconia and SSC
• Status: Completed
• Phase: N/A
• First received: January 22, 2017
• Last updated: February 24, 2017
• Start date: August 30, 2015
• Est. completion date: December 30, 2016

Study information

• Verified date: February 2017
• Source: King Abdulaziz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 30, 2016
• Est. primary completion date: August 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tooth Diseases

Intervention

Device:
• Stainless Steel Crown (Group A)
Full coverage restoration for multi-surface carious teeth
• NuSmile Zirconia Crowns (Group B)
Full coverage restoration for multi-surface carious teeth

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King Abdulaziz University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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