Success of Zirconia and Stainless Steel Crowns for Permanent Molars

Sponsor

Hacettepe University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05049694

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Caries Active Dentin, Carious	Device: zirconia crowns Device: stainless steel crowns	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Clinical and Radiographic Performance of Zirconia and Stainless Steel Crowns for Permanent Molars

Actual Study Start Date :

Aug 1, 2019

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: zirconia crowns esthetic crowns for capping permanent molars with caries	Device: zirconia crowns esthetic crowns for capping permanent molars with caries
Experimental: stainless steel crowns stainless steel crowns for capping permanent molars with caries	Device: stainless steel crowns stainless steel crowns for capping permanent molars with caries

Arm

Intervention/Treatment

Experimental: zirconia crowns

esthetic crowns for capping permanent molars with caries

Device: zirconia crowns

esthetic crowns for capping permanent molars with caries

Experimental: stainless steel crowns

stainless steel crowns for capping permanent molars with caries

Device: stainless steel crowns

stainless steel crowns for capping permanent molars with caries

Outcome Measures

Primary Outcome Measures

Number of zirconia and stainless steel crowns that showed successful retention over two years [2 years]
Long-term clinical success of zirconia and stainless steel crowns placed on permanent molars

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 13 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hacettepe University	Ankara		Turkey	06100

Sponsors and Collaborators

Hacettepe University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zafer Cavit Cehreli, DDS, PhD, Prof.Dr., Hacettepe University

ClinicalTrials.gov Identifier:

NCT05049694

Other Study ID Numbers:

posterior permanent crown rest

First Posted:

Sep 20, 2021

Last Update Posted:

Sep 24, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Zafer Cavit Cehreli, DDS, PhD, Prof.Dr., Hacettepe University

zirconia crowns

stainless steel crowns

dental caries

Additional relevant MeSH terms:

Dental Caries

Study Results

No Results Posted as of Sep 24, 2021