Clinical Efficacy of Preformed Pediatric Zirconia and Metal Crown

April 24, 2026 updated by: Haner Direskeneli, Marmara University

Evaluation of Clinical Efficacy of Preformed Pediatric Zirconia Crown and Preformed Pediatric Metal Crown: A Randomized Clinical Study

The study was planned to evaluate and compare the clinical success of prefabricated stainless steel crowns and zirconia crowns used in the primary molars.

The study will be carried out in healthy children aged 6-9 years with caries on more than one surface of the primary molars.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this study, zirconia crowns will be compared with prefabricated stainless steel crowns in a randomized controlled manner. The study will be conducted in split-mouth to eliminate the effect of potential confounders. The obtained data will be analyzed using appropriate statistical methods.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Ecem Akbeyaz Şivet, DDS

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy children aged 6-9 years with caries on primary molars
  • Children without systemic disease or developmental dental anomalies that may affect caries susceptibility.
  • Children whose cooperation is 'positive' or 'absolutely positive' according to the Frankl behavioral scale (Frankl et al., 1962).
  • Those with deep dentin caries that do not extend to the pulp in the teeth to be treated
  • The molars will be treated with a crown indication.
  • Presence of symmetry of the primary molar to be treated in the opposite arch.
  • The molar to be treated is in occlusion with the antagonist.
  • Presence of caries on at least two surfaces of the molars to be treated.
  • Absence of spontaneous pain, abscess, mobility, interradicular lesion in the tooth to be treated
  • Patients whose parents and themselves agree to participate in the treatment

Exclusion Criteria:

  • Children whose treatment cannot be continued on the dental chair due to cooperation
  • Molars that will soon be exfoliated, 1/2 of the root has been resorbed
  • The presence of bruxism
  • The presence of erosion or attrition-related wear on the opposing molar
  • The patient does not come to the control appointment or does not want to continue to the research
  • Have allergy to local anesthetic, nickel or chromium
  • Complications during treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Prefabricated pediatric zirconia crown group
Zirconia crowns (ZK; EZ Crowns, Spring Oral Health Technologies, Inc:, Loomis, Calif., USA).
Procedure: Prefabricated pediatric zirconia crown group
Zirconia crown application: After preparing the molars, the crown was cemented by passive seating with modified glass ionomer cement (GC FujiCEM Evolve, GC America, Alsip, USA).
Active Comparator: Prefabricated stainless steel crown group
Stainless Steel Crown (SSC, Kids Crown, Shinghung, Seoul, Korea)
Procedure: Prefabricated stainless steel crown group
Stainless steel crown application: After preparing the molars, the crown was filled with type-1 glass ionomer cement (Aqua Meron, Voco, Cuxhaven, Germany) and cemented.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Comparison of clinical success
Time Frame: 24 month

According to the criteria reported by Santamaria et al. (2004), clinical success will be categorized as successful, major failure, and minor failure.

Successful:

  • No clinical signs or symptoms of pulp pathology
  • Tooth has exfoliated (without any minor/major failures)
  • No deformations in the crown/restoration
  • No pathology observed in radiographs

Minor failure:

  • Reversible pulpitis (No need for root canal treatment or extraction)
  • Crown/restoration loss that can be restored
  • Presence of deformations/fractures/perforations in the crown/restoration
  • Permanent crown remaining submerged
  • Presence of new caries at the margins

Major failure:

  • Irreversible pulpitis
  • Crown/restoration loss that cannot be restored
  • Inter-radicular radiolucency
  • Internal root resorption
24 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parental satisfaction
Time Frame: 24 month

To assess parental satisfaction regarding the applied restorations, scoring of crowns' appearance, color, shape, size, and general appearance will be requested using a Likert-type scale (Suguna & Gurunathan, 2021). Score 5 indicates the highest level of satisfaction, while score 1 represents the lowest level of satisfaction.

  1. Not at all satisfied
  2. Not satisfied
  3. Neither satisfied nor dissatisfied (Neutral)
  4. Satisfied
  5. Very satisfied
24 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 23, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 18, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 20, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17.05.23marmara

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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