Custom-made Zirconia Crowns Versus Prefabricated Zirconia Crowns in Young Permanent Molars

July 9, 2026 updated by: Jordan University of Science and Technology

Custom-made Zirconia Crowns Versus Prefabricated Zirconia Crowns in Young Permanent Molars: A Randomised Controlled Trial

This study aims to compare the clinical performance of Prefabricated Zirconia Crowns (PZCs) with that of Custom-made Zirconia Crowns (CZCs) using enhanced clinical protocols.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

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

Young permanent molars presenting with gross caries, pulpal treatment or developmental defects often require full coverage restorations. Recently, the Prefabricated Zirconia Crowns (PZCs) have been introduced as a biocompatible and an aesthetically pleasant option with promising outcomes. However, it comes in specific sizes, limited shades and a significant tooth preparation is often required. Custom-made zirconia crowns (CZCs), fabricated using CAD/CAM technology may; offer a favorable aesthetic alternative by ensuring a controlled tooth reduction, precise fit, better aesthetics, and improved retention. Nevertheless, the current evidence concerning its use in young permanent molars remains limited. This study will be a randomised clinical trial that aims to compare the clinical performance of (PZCs) with that of (CZCs) for the restoration of badly carious/destructed young permanent molars in children aged 7-13. Patients will be randomised into two treatment groups using an online block randomisation technique (block size of 6) and sealed-envelope techniques. Clinical parameters: retention, fracture, gingival health and marginal integrity will be evaluated at 3-month, 6-month, and 12-month intervals. In addition, treatment duration, intraoperative patient comfort and immediate postoperative patient satisfaction will be evaluated and compared. The findings of this study are expected to provide evidence on the suitability of CZC for young permanent molars in children. The Null hypothesis is that there is no difference between the two types of crowns in terms of clinical performance and child acceptance.

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 (Estimated)

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.
50

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

  • Jordan
      • Irbid, Jordan
        • Jordan University of 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:

  • Medically fit or with mild systemic illness (ASA I or II).
  • Children who assent to take part in the study with a valid parental consent
  • Children who have at least one first permanent molar requiring a full-coverage restoration (indications for placing a crown include: badly destructed/carious molars, or teeth affected by molar-incisor hypomineralisation (MIH))
  • Maxillary or mandibular fully erupted first permanent molars, regardless of the stage of root development.
  • A cooperative child that accepts dental treatment (Frankle Behaviour Rating Scale #3 or 4).
  • Capable of attending all follow-up sessions.

Exclusion Criteria:

  • Patients outside the required age range
  • Parents/child not willing to participate.
  • Medically compromised patients
  • Partially erupted permanent first molars.
  • Patients with severe malocclusion that prohibits the provision of crowns
  • First permanent molars are not indicated for full coverage restorations.
  • First permanent molars are indicated for extraction.
  • Patients with bruxism or parafunctional habits.
  • Uncooperative children (Frankle Behaviour Rating Scale #1 or 2)

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.
Experimental: Prefabricated Zirconia Crowns
Tooth preparation and cementation of a suitable size of prefabricated Zirconia crown.
Procedure: Prefabricated Zirconia Crown
Tooth preparation as per the manufacturer's instructions and cementation of a suitable size of prefabricated Zirconia crown using self-adhesive resin cement.
Experimental: Custom-made Zirconia Crowns
Tooth preparation, followed by oral scanning and production and cementation of a zirconia crown using CAD-CAM technology.
Procedure: Custom-made Zirconia Crowns
Tooth preparation (1-1.5 mm occlusal, 0.5 to 1.25 mm circumferential, with a shoulder-edge supra-gingival margin), followed by scanning with an intra-oral scanner, then temporisation. A zirconia crown will be produced using CAD-CAM technology and cemented with a self-adhesive resin cement on a different visit.

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
Rate of Crown retention
Time Frame: 3,6 and 12 months
Visual-tactile evaluation of the crown retention over time (crown present, loose or lost).
3,6 and 12 months
Rate of chipping and fracture of the crown
Time Frame: 3,6 and 12 months
Clinical evaluation for the presence/absence of crown chipping or fracture
3,6 and 12 months
Gingival health
Time Frame: 3,6 and 12 months
Clinical evaluation of the gingival inflammation ( the gingival index (GI) by Löe & Silness 1963 )
3,6 and 12 months
Clinical crown margin extension
Time Frame: 3,6 and 12 months
Visual-tactile evaluation for crown margin extension (supra/ equi/sub-- gingival)
3,6 and 12 months
Radiographic crown margin adaptation
Time Frame: 6 and 12 months
Evaluation of crown margin adaptation (Geduk et al., 2023)
6 and 12 months
Clinical crown margin adaptation
Time Frame: 3,6 and 12 months
Clinical evaluation of crown margin using an explorer (Geduk et al., 2023)
3,6 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
Time taken for intervention
Time Frame: Perioperative/Periprocedural: from the beginning of tooth preparation and until the crown is cemented.
Total time taken to perform the intervention for each crown (crown preparation, try-in and cementation) in minutes.
Perioperative/Periprocedural: from the beginning of tooth preparation and until the crown is cemented.
Patient satisfaction
Time Frame: immediately following intervention.
Self-reported child acceptance using a 5-points visual analogue scale
immediately following intervention.
Patient's comfort
Time Frame: peri-operatively
will be evaluated by an observer (research assistant who will be trained, and calibrated) and recorded using the Sound, Eyes, and motor scale (SEM); Based on the intensity of the child's discomfort, each parameter is scored into one of four categories (comfort (score 0), mild discomfort (score 1), moderately painful (score 2), and painful (score 3)). The total score can range from 0 to 9, with 9 indicating the highest level of discomfort.
peri-operatively

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.
Jordan University of Science and Technology

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.
August 1, 2025

Primary Completion (Estimated)

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.
December 31, 2027

Study Completion (Estimated)

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 31, 2027

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).
March 25, 2026

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.
July 9, 2026

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.
July 15, 2026

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.
July 15, 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.
July 9, 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.
July 1, 2026

More Information

Terms related to this study

Keywords

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.
  • 245-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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