Zirconia CrownsNCT07704151
Custom-made Zirconia Crowns Versus Prefabricated Zirconia Crowns in Young Permanent Molars
A study testing Prefabricated Zirconia Crown and Custom-made Zirconia Crowns in people with Zirconia Crowns, run by Jordan University of Science and Technology at 1 site in Jordan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Zirconia Crowns
- What is being tested?
- Prefabricated Zirconia Crown and Custom-made Zirconia Crowns
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteJordan
- Study dates
- 1 Aug 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- First permanent molars are indicated for extraction.
- Patients with bruxism or parafunctional habits.
- Uncooperative children (Frankle Behaviour Rating Scale #1 or 2)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Zirconia Crowns
- Being tested
- Prefabricated Zirconia Crown, Custom-made Zirconia Crowns
- Keywords
- Zirconia crowns, Prefabricated Zirconia crowns, Custom-made Zirconia crowns, Children, Young permanent molars
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prefabricated Zirconia CrownProcedure or surgery
Tooth preparation as per the manufacturer's instructions and cementation of a suitable size of prefabricated Zirconia crown using self-adhesive resin cement.
Custom-made Zirconia CrownsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Prefabricated Zirconia Crowns | Experimental | Tooth preparation and cementation of a suitable size of prefabricated Zirconia crown. Receives: Procedure: Prefabricated Zirconia Crown |
| Custom-made Zirconia Crowns | Experimental | Tooth preparation, followed by oral scanning and production and cementation of a zirconia crown using CAD-CAM technology. Receives: Procedure: Custom-made Zirconia Crowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Crown retention
Visual-tactile evaluation of the crown retention over time (crown present, loose or lost).
Measured: 3,6 and 12 months
Rate of chipping and fracture of the crown
Clinical evaluation for the presence/absence of crown chipping or fracture
Measured: 3,6 and 12 months
Gingival health
Clinical evaluation of the gingival inflammation ( the gingival index (GI) by Löe \& Silness 1963 )
Measured: 3,6 and 12 months
Clinical crown margin extension
Visual-tactile evaluation for crown margin extension (supra/ equi/sub-- gingival)
Measured: 3,6 and 12 months
Radiographic crown margin adaptation
Evaluation of crown margin adaptation (Geduk et al., 2023)
Measured: 6 and 12 months
Clinical crown margin adaptation
Clinical evaluation of crown margin using an explorer (Geduk et al., 2023)
Measured: 3,6 and 12 months
Secondary outcomes (3)
Time taken for intervention
Total time taken to perform the intervention for each crown (crown preparation, try-in and cementation) in minutes.
Measured: Perioperative/Periprocedural: from the beginning of tooth preparation and until the crown is cemented.
Patient satisfaction
Self-reported child acceptance using a 5-points visual analogue scale
Measured: immediately following intervention.
Patient's comfort
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.
Measured: peri-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Aug 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Zirconia CrownsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704151
- Sponsor's protocol ID
- 245-2025
- Status last verified
- Jul 2026
- First submitted
- 25 Mar 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Custom-made Zirconia Crowns Versus Prefabricated Zirconia Crowns in Young Permanent Molars: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07704151
- Acronym / sponsor ID
- 245-2025
- Conditions
- Zirconia Crowns
- Keywords
- Zirconia crowns, Prefabricated Zirconia crowns, Custom-made Zirconia crowns, Children, Young permanent molars
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prefabricated Zirconia Crowns | Experimental | Procedure: Prefabricated Zirconia CrownTooth preparation and cementation of a suitable size of prefabricated Zirconia crown. |
| Custom-made Zirconia Crowns | Experimental | Procedure: Custom-made Zirconia CrownsTooth preparation, followed by oral scanning and production and cementation of a zirconia crown using CAD-CAM technology. |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prefabricated Zirconia CrownTooth preparation as per the manufacturer's instructions and cementation of a suitable size of prefabricated Zirconia crown using self-adhesive resin cement. | Procedure or surgery | Prefabricated Zirconia Crowns |
| Custom-made Zirconia CrownsTooth 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. | Procedure or surgery | Custom-made Zirconia Crowns |
Primary outcome
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).
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
Gingival health
Time frame: 3,6 and 12 months
Clinical evaluation of the gingival inflammation ( the gingival index (GI) by Löe \& Silness 1963 )
Clinical crown margin extension
Time frame: 3,6 and 12 months
Visual-tactile evaluation for crown margin extension (supra/ equi/sub-- gingival)
Radiographic crown margin adaptation
Time frame: 6 and 12 months
Evaluation of crown margin adaptation (Geduk et al., 2023)
Clinical crown margin adaptation
Time frame: 3,6 and 12 months
Clinical evaluation of crown margin using an explorer (Geduk et al., 2023)
3 secondary outcomes
Time taken for intervention
Time frame: Perioperative/Periprocedural: from the beginning of tooth preparation and until the crown is cemented.
Patient satisfaction
Time frame: immediately following intervention.
Patient's comfort
Time frame: peri-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prefabricated Zirconia Crown and Custom-made Zirconia Crowns in people with Zirconia Crowns, run by Jordan University of Science and Technology at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Crown retention (time frame: 3,6 and 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.