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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05049694
Other study ID # posterior permanent crown rest
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
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Completed NCT04756557 - Caries-preventing Effect of a Hydroxyapatite-toothpaste in Adults N/A
Enrolling by invitation NCT03433157 - Assessment of Stainless Stain Crowns Placed Using the Hall Technique and Traditional Technique N/A