Carious TeethNCT05910905
Clinical Efficacy of Preformed Pediatric Zirconia and Metal Crown
A study testing Prefabricated pediatric zirconia crown group and Prefabricated stainless steel crown group in people with Carious Teeth, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Carious Teeth
- What is being tested?
- Prefabricated pediatric zirconia crown group and Prefabricated stainless steel crown group
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jan 2025to 18 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Carious Teeth
- Being tested
- Prefabricated pediatric zirconia crown group, Prefabricated stainless steel crown group
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prefabricated pediatric zirconia crown groupProcedure or surgery
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).
Prefabricated stainless steel crown groupProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Prefabricated pediatric zirconia crown group | Experimental | Zirconia crowns (ZK; EZ Crowns, Spring Oral Health Technologies, Inc:, Loomis, Calif., USA). Receives: Procedure: Prefabricated pediatric zirconia crown group |
| Prefabricated stainless steel crown group | Active comparator | Stainless Steel Crown (SSC, Kids Crown, Shinghung, Seoul, Korea) Receives: Procedure: Prefabricated stainless steel crown group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of clinical success
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
Measured: 24 month
Secondary outcomes (1)
Parental satisfaction
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.
- Not at all satisfied
- Not satisfied
- Neither satisfied nor dissatisfied (Neutral)
- Satisfied
- Very satisfied
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2023
- Study start23 Jan 2025
- Primary completion1 Nov 2025
- Study completion18 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carious TeethStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haner Direskeneli, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910905
- Sponsor's protocol ID
- 17.05.23marmara
- Status last verified
- Apr 2026
- First submitted
- 26 May 2023
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Efficacy of Preformed Pediatric Zirconia Crown and Preformed Pediatric Metal Crown: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT05910905
- Acronym / sponsor ID
- 17.05.23marmara
- Conditions
- Carious Teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 18 Dec 2025 (actual)
- First posted
- 20 Jun 2023 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prefabricated pediatric zirconia crown group | Experimental | Procedure: Prefabricated pediatric zirconia crown groupZirconia crowns (ZK; EZ Crowns, Spring Oral Health Technologies, Inc:, Loomis, Calif., USA). |
| Prefabricated stainless steel crown group | Active comparator | Procedure: Prefabricated stainless steel crown groupStainless Steel Crown (SSC, Kids Crown, Shinghung, Seoul, Korea) |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
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 pediatric zirconia crown groupZirconia 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). | Procedure or surgery | Prefabricated pediatric zirconia crown group |
| Prefabricated stainless steel crown groupStainless steel crown application: After preparing the molars, the crown was filled with type-1 glass ionomer cement (Aqua Meron, Voco, Cuxhaven, Germany) and cemented. | Procedure or surgery | Prefabricated stainless steel crown group |
Primary outcome
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
1 secondary outcome
Parental satisfaction
Time frame: 24 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 pediatric zirconia crown group and Prefabricated stainless steel crown group in people with Carious Teeth, run by Marmara University at 1 site in Turkey (Türkiye).
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 10 inclusion and 7 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: finished, as of the sponsor's last update on 29 Apr 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of clinical success (time frame: 24 month). 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 29 Apr 2026.