Clinical Comparison Between Stainless-steel Crown, Zirconia Crown and Bioflx Crown in Primary Molars

November 30, 2024 updated by: Delta University for Science and Technology

Clinical Comparison Between Stainless-steel Crown, Zirconia Crown and Bioflx Crown in Primary Molars: Randomized Control Trial

The purpose of this clinical trial was to compare clinically three different crowns for primary molars; stainless steel crown, zirconia crown and Bioflx crown.

the main questions it aims to answer are: is Bioflex crown is an alternative to stainless steel crown and zirconia crown? Seventy-five patients their age range between 3 and 8 years participated in this study. The participants are divided into three groups representing group A for stainless steel crown (n=25), group B for zirconia crown (n=25) and group C for Bioflx crown (n=25). Plaque index, crown retentivity and gingival index will be evaluated at evaluated at baseline, 6 and 12 months.

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.

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.
75

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 Locations

  • Egypt
    • El Dakhleia
      • Gamasa, El Dakhleia, Egypt, 11152
        • Delta University for Science and Technology

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:

  • Patient within the age group of 3-8 years old.
  • Healthy children free of any systemic disease.
  • Pulpotomized or pulpectomized (endodontically treated) lower second primary molars.
  • Patients who have the behavioral rating of definitely positive or positive according to the frankl behaviour.

Exclusion Criteria:

  • • Patient younger than 3 years old or older than 8 years old.

    • non-Healthy children or have any systemic disease.
    • primary molars with no pulpal treatment
    • Patients who have the behavioral rating of definitely negative or negative according to the frankl behaviour.

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: Single

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.
Active Comparator: stainless steel crown
Participants in this arm will receive stainless steel crowns for primary teeth.
Device: stainless steel crown
Participants in this arm received a stainless steel crown for primary teeth restoration. The crowns were selected based on the clinical assessment of the patient's dental need.
Device: Zirconia crown
Participants in this arm received a zirconia crown for primary teeth restoration. The crowns were selected to provide a more aesthetic and durable option compared to stainless steel.
Device: Bioflx crown
Participants in this arm received a Bioflx crown, which is a flexible, biocompatible material often used for pediatric crowns.
Experimental: zirconia crown
Participants in this arm will receive zirconia crowns for primary teeth.
Device: stainless steel crown
Participants in this arm received a stainless steel crown for primary teeth restoration. The crowns were selected based on the clinical assessment of the patient's dental need.
Device: Zirconia crown
Participants in this arm received a zirconia crown for primary teeth restoration. The crowns were selected to provide a more aesthetic and durable option compared to stainless steel.
Device: Bioflx crown
Participants in this arm received a Bioflx crown, which is a flexible, biocompatible material often used for pediatric crowns.
Experimental: Bioflx crown
Participants in this arm will receive Bioflex crowns for primary teeth.
Device: stainless steel crown
Participants in this arm received a stainless steel crown for primary teeth restoration. The crowns were selected based on the clinical assessment of the patient's dental need.
Device: Zirconia crown
Participants in this arm received a zirconia crown for primary teeth restoration. The crowns were selected to provide a more aesthetic and durable option compared to stainless steel.
Device: Bioflx crown
Participants in this arm received a Bioflx crown, which is a flexible, biocompatible material often used for pediatric crowns.

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
Plaque accumulation
Time Frame: 6 months and 12 months
Measured using the Löe and Silness index, where each of the four surfaces of the crown (buccal, lingual, mesial, and distal) was scored from 0 to 3 (0 = no plaque, 3 = abundance of soft matter). The scores from the four areas were added and divided by four to obtain the plaque index
6 months and 12 months

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
crown retention
Time Frame: 6 months and 12 months
Assessed using the USPHS criteria, where "Alpha" indicated the crown was continuous with the existing anatomic form, "Bravo" indicated a missing part of the crown but not enough to expose the underlying dentin/base, and "Charlie" indicated sufficient loss of crown substance to expose the underlying dentin/base or complete loss of the crown
6 months and 12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gingival health
Time Frame: 6 months and 12 months
Evaluated using the bleeding index according to Löe and Silness (1963), with scores of 0 (no inflammation), 1 (mild inflammation), 2 (moderate inflammation), and 3 (severe inflammation).
6 months and 12 months

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.
Delta University for Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
September 1, 2023

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.
September 1, 2024

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.
September 30, 2024

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).
November 23, 2024

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.
November 23, 2024

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.
November 26, 2024

Study Record Updates

Last Update Posted (Estimated)

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.
December 4, 2024

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.
November 30, 2024

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.
November 1, 2024

More Information

Terms related to this study

Keywords

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.
  • DU0240721024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We are currently reviewing the potential for sharing individual participant data (IPD) following the completion of the study. Factors such as data privacy, participant consent, and regulatory guidelines are being considered. A final decision on data sharing will be made at the conclusion of the study, and the IPD sharing plan will be updated accordingly

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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