Success of Zirconia and Stainless Steel Crowns for Permanent Molars

Dentin, Carious Clinical Trial

Official title:

Clinical and Radiographic Performance of Preformed Zirconia Crowns and Stainless-Steel Crowns in Permanent First Molars: 18-Month Results of a Prospective, Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05049694
• Other study ID #: posterior permanent crown rest
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: August 1, 2022

Study information

• Verified date: April 2023
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate and compare the clinical and radiographic performance of zirconia and stainless steel crowns on permanent molar

Description:

Zirconia and stainless steel crowns will be placed on at least two permanent molars, in a split mouth design. 100 patients will be included in the study. The teeth will be randomized into two groups according to the crown type. Group 1: Zirconia crown 2: Stainless steel crown. Plaque index, gingival index, crown retention, presence of restoration failure, gingival margin extension and pulpal health of the teeth will be clinically evaluated at baseline and 1., 6., 12., 18., 24. months. The restorations will be evaluated radiographically at 6., 12. and 18. months. Intra-oral photos will be taken directly after treatment and at control appointments. The data will be analysed statistically using Fisher's Exact Test and pearson's chi-square test; and Log-rank and the Kaplan-Meier will be used to estimate survival percentages.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 13 Years

Eligibility

Inclusion Criteria:

• Patients and parent of the patients who accept to participate and sign the informed consent
• Patients who have at least two permanent molars with caries that require crown restoration
• Patients that have good cooperation to the procedure

Exclusion Criteria:

• Patients and parent of the patients who don't accept to participate and sign the informed consent
• Teeth that doesn't have opposing permanent molars
• Patients who have bruxism or deep-bite
• Patient who are allergic to nickel

Related Conditions & MeSH terms

• Dental Caries
• Dentin, Carious

Intervention

Device:
• zirconia crowns
esthetic crowns for capping permanent molars with caries
• stainless steel crowns
stainless steel crowns for capping permanent molars with caries

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of zirconia and stainless steel crowns that showed successful retention over two years	Long-term clinical success of zirconia and stainless steel crowns placed on permanent molars	2 years