NCT05049694

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 20, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

April 7, 2023

Status Verified

April 1, 2023

Enrollment Period

2.4 years

First QC Date

September 9, 2021

Last Update Submit

April 6, 2023

Conditions

Caries ActiveDentin, Carious

Keywords

zirconia crownsstainless steel crownsdental caries

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

zirconia crowns

EXPERIMENTAL

esthetic crowns for capping permanent molars with caries

Device: zirconia crowns

stainless steel crowns

EXPERIMENTAL

stainless steel crowns for capping permanent molars with caries

Device: stainless steel crowns

Interventions

zirconia crownsDEVICE

esthetic crowns for capping permanent molars with caries

zirconia crowns
stainless steel crownsDEVICE

stainless steel crowns for capping permanent molars with caries

stainless steel crowns

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (1)

  • Geduk N, Ozdemir M, Erbas Unverdi G, Ballikaya E, Cehreli ZC. Clinical and radiographic performance of preformed zirconia crowns and stainless-steel crowns in permanent first molars: 18-month results of a prospective, randomized trial. BMC Oral Health. 2023 Nov 3;23(1):828. doi: 10.1186/s12903-023-03501-1.

    PMID: 37924021DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.Dr.

Study Record Dates

First Submitted

September 9, 2021

First Posted

September 20, 2021

Study Start

August 1, 2019

Primary Completion

January 1, 2022

Study Completion

August 1, 2022

Last Updated

April 7, 2023

Record last verified: 2023-04

Locations

TU(1)