Dental Caries in Primary TeethNCT07426445
CLINICAL PERFORMANCE OF PEDIATRIC CROWNS IN PRIMARY MOLAR
A study testing Prefabricated Zirconia Crown and Prefabricated Nanohybrid Composite Crown in people with Dental Caries in Primary Teeth and Full-Coverage Restorations in Pediatric Dentistry, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the clinical success of three different types of prefabricated crowns commonly used in primary molar teeth: nanohybrid composite crowns, zirconia crowns, and stainless steel crowns. Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Dental Caries in Primary Teeth, Full-Coverage Restorations in Pediatric Dentistry
- What is being tested?
- Prefabricated Zirconia Crown and Prefabricated Nanohybrid Composite Crown
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jan 2025to 11 Jan 2026
- 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 4 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 4 to 9 years with no systemic diseases (ASA I).
- Cooperative behavior assessed as Frankl Score 3 (Positive) or 4 (Definitely Positive).
- Written informed consent obtained from the parent/legal guardian and assent from the child.
- Willingness to attend all scheduled follow-up visits.
- Presence of bilateral mandibular second primary molars (teeth 75 and 85) with multisurface carious lesions.
- Presence of an opposing antagonist tooth in occlusion.
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- Carious lesions classified as ICDAS II Score 4, 5, or 6.
- Radiographic caries depth extending to D1-RA3, D2-RB4, or D3-RC5.
- Root resorption not exceeding one-third of the root length.
- No radiographic evidence of periapical or furcation radiolucency.
- Normal periodontal ligament space and intact lamina dura.
- No evidence of internal or external root resorption.
Who cannot join
- Children classified as ASA II or higher or having systemic diseases.
- Frankl Behavior Rating Scale Score 1 or 2.
- Unwillingness to attend follow-up visits or provide informed consent.
- Presence of temporomandibular joint disorders.
- Presence of parafunctional habits such as bruxism.
- Absence of one or both mandibular second primary molars.
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- Absence of an opposing antagonist tooth.
- Carious lesions classified as ICDAS II Score 1, 2, or 3.
- Radiographic findings limited to enamel caries or no evidence of caries (E0-R0, E1-RA1, E2-RA2).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Pediatric Dentistry
Izmir, İzmir, 35550
About this study
Official title: Comparative Evaluation Of The Clinical Success Of Prefabricated Nanohybrid Composite, Zirconia, And Stainless Steel Crowns In Primary Teeth: A Randomized Controlled Trial
The aim of this study is to compare the clinical success of three different types of prefabricated crowns commonly used in primary molar teeth: nanohybrid composite crowns, zirconia crowns, and stainless steel crowns. Primary molar teeth play a critical role in supporting growth and development by facilitating mastication and nutrition and by maintaining space for the eruption of permanent successor teeth. Current guidelines in pediatric dentistry recommend stainless steel crowns for the restoration of primary molars with extensive carious lesions. However, increasing esthetic demands have led to the development and growing use of alternative crown systems, such as zirconia and nanohybrid composite crowns.
This study will be conducted on 50 children aged 4 to 9 years who present to the Department of Pediatric Dentistry at Izmir Katip Celebi University Faculty of Dentistry, have no systemic diseases, and have no known allergies to local anesthetic agents. Children presenting with carious lesions affecting both mandibular second primary molars will be included. Clinically, teeth with International Caries Detection and Assessment System (ICDAS II) scores of 4, 5, and 6 will be eligible. Radiographically, lesions classified as D1-RA3, D2-RB4, and D3-RC5 will be included.
Read more
The study will be designed as a randomized, controlled, parallel-group clinical trial. Participants will be randomly allocated into two groups: in one group, prefabricated zirconia crowns and stainless steel crowns will be placed, while in the other group, nanohybrid composite crowns and stainless steel crowns will be applied.
The primary outcome of the study is to evaluate and compare the clinical success of the three crown types at 3, 6, 9, and 12 months following treatment based on functional, esthetic, and biological criteria. Functional outcomes will include crown retention and material loss, marginal adaptation, antagonist tooth wear, and occlusal height of the crown. Esthetic outcomes will be assessed in terms of surface roughness, color match, and anatomical form. Biological outcomes will include periodontal health. As a secondary outcome, parental satisfaction will be evaluated to assess perceptions of treatment success and factors influencing crown preference.
The results of this study are expected to provide valuable clinical evidence to guide the selection of the most appropriate prefabricated crown type for primary molars in pediatric dentistry.
- Being tested
- Prefabricated Zirconia Crown, Prefabricated Nanohybrid Composite Crown
- Keywords
- Pediatric Dentistry, Primary Molars, Prefabricated Crowns, Stainless Steel Crowns, Zirconia Crowns, Nanohybrid Composite Crowns, FDI Criteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prefabricated Zirconia CrownDevice
Prefabricated zirconia crowns are used for full coronal restoration of mandibular second primary molars.
Prefabricated Nanohybrid Composite CrownDevice
Prefabricated nanohybrid composite crowns are used for full coronal restoration of mandibular second primary molars.
| Study group | Role | What they receive |
|---|---|---|
| Zirconia Crown Group | Experimental | Participants receive prefabricated zirconia crowns and stainless steel crowns for the restoration of mandibular second primary molars. Clinical outcomes are evaluated during follow-up visits. Receives: Device: Prefabricated Zirconia Crown |
| Nanohybrid Composite Crown Group | Experimental | Participants receive prefabricated nanohybrid composite crowns and stainless steel crowns for the restoration of mandibular second primary molars. Clinical outcomes are evaluated during follow-up visits. Receives: Device: Prefabricated Nanohybrid Composite Crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success of Prefabricated Crowns Based on FDI Criteria
Clinical success of prefabricated crowns is evaluated according to the World Dental Federation clinical evaluation criteria (FDI). Functional properties include crown retention and material loss, marginal adaptation, antagonist tooth wear, and occlusal height of the crown. Esthetic properties include surface roughness, color match, and anatomical form. Biological properties include periodontal health. Overall clinical performance is assessed at each follow-up visit.
Measured: 3, 6, 9, and 12 months after crown placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start11 Jan 2025
- Primary completion11 Jan 2026
- Study completion11 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries in Primary TeethStudies 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
- Model description
- This is a randomized, controlled, parallel-group clinical trial. Participants are randomly allocated into two groups. One group receives prefabricated zirconia crowns and stainless steel crowns, while the other group receives nanohybrid composite crowns and stainless steel crowns applied to mandibular second primary molars.
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve AKCAY, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426445
- Sponsor's protocol ID
- IKCU-PEDO-SSC-ZR-NNK-01
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient confidentiality concerns. The study involves pediatric participants, and all data will be analyzed and reported in aggregate form to ensure privacy and compliance with ethical standards.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation Of The Clinical Success Of Prefabricated Nanohybrid Composite, Zirconia, And Stainless Steel Crowns In Primary Teeth: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07426445
- Acronym / sponsor ID
- IKCU-PEDO-SSC-ZR-NNK-01
- Keywords
- Pediatric Dentistry, Primary Molars, Prefabricated Crowns, Stainless Steel Crowns, Zirconia Crowns, Nanohybrid Composite Crowns, FDI Criteria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 11 Jan 2025 (actual)
- Primary completion
- 11 Jan 2026 (actual)
- Study completion
- 11 Jan 2026 (actual)
- First posted
- 23 Feb 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.
The aim of this study is to compare the clinical success of three different types of prefabricated crowns commonly used in primary molar teeth: nanohybrid composite crowns, zirconia crowns, and stainless steel crowns. Primary molar teeth play a critical role in supporting growth and development by facilitating mastication and nutrition and by maintaining space for the eruption of permanent successor teeth. Current guidelines in pediatric dentistry recommend stainless steel crowns for the restoration of primary molars with extensive carious lesions. However, increasing esthetic demands have led to the development and growing use of alternative crown systems, such as zirconia and nanohybrid composite crowns.
This study will be conducted on 50 children aged 4 to 9 years who present to the Department of Pediatric Dentistry at Izmir Katip Celebi University Faculty of Dentistry, have no systemic diseases, and have no known allergies to local anesthetic agents. Children presenting with carious lesions affecting both mandibular second primary molars will be included. Clinically, teeth with International Caries Detection and Assessment System (ICDAS II) scores of 4, 5, and 6 will be eligible. Radiographically, lesions classified as D1-RA3, D2-RB4, and D3-RC5 will be included.
The study will be designed as a randomized, controlled, parallel-group clinical trial. Participants will be randomly allocated into two groups: in one group, prefabricated zirconia crowns and stainless steel crowns will be placed, while in the other group, nanohybrid composite crowns and stainless steel crowns will be applied.
The primary outcome of the study is to evaluate and compare the clinical success of the three crown types at 3, 6, 9, and 12 months following treatment based on functional, esthetic, and biological criteria. Functional outcomes will include crown retention and material loss, marginal adaptation, antagonist tooth wear, and occlusal height of the crown. Esthetic outcomes will be assessed in terms of surface roughness, color match, and anatomical form. Biological outcomes will include periodontal health. As a secondary outcome, parental satisfaction will be evaluated to assess perceptions of treatment success and factors influencing crown preference.
The results of this study are expected to provide valuable clinical evidence to guide the selection of the most appropriate prefabricated crown type for primary molars in pediatric dentistry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized, controlled, parallel-group clinical trial. Participants are randomly allocated into two groups. One group receives prefabricated zirconia crowns and stainless steel crowns, while the other group receives nanohybrid composite crowns and stainless steel crowns applied to mandibular second primary molars.
| Arm | Type | Receives |
|---|---|---|
| Zirconia Crown Group | Experimental | Device: Prefabricated Zirconia CrownParticipants receive prefabricated zirconia crowns and stainless steel crowns for the restoration of mandibular second primary molars. Clinical outcomes are evaluated during follow-up visits. |
| Nanohybrid Composite Crown Group | Experimental | Device: Prefabricated Nanohybrid Composite CrownParticipants receive prefabricated nanohybrid composite crowns and stainless steel crowns for the restoration of mandibular second primary molars. Clinical outcomes are evaluated during follow-up visits. |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Children aged 4 to 9 years with no systemic diseases (ASA I).
- Cooperative behavior assessed as Frankl Score 3 (Positive) or 4 (Definitely Positive).
- Written informed consent obtained from the parent/legal guardian and assent from the child.
- Willingness to attend all scheduled follow-up visits.
- Presence of bilateral mandibular second primary molars (teeth 75 and 85) with multisurface carious lesions.
Key exclusion criteria (9 listed)
- Children classified as ASA II or higher or having systemic diseases.
- Frankl Behavior Rating Scale Score 1 or 2.
- Unwillingness to attend follow-up visits or provide informed consent.
- Presence of temporomandibular joint disorders.
- Presence of parafunctional habits such as bruxism.
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 CrownPrefabricated zirconia crowns are used for full coronal restoration of mandibular second primary molars. | Device | Zirconia Crown Group |
| Prefabricated Nanohybrid Composite CrownPrefabricated nanohybrid composite crowns are used for full coronal restoration of mandibular second primary molars. | Device | Nanohybrid Composite Crown Group |
Primary outcome
Clinical Success of Prefabricated Crowns Based on FDI Criteria
Time frame: 3, 6, 9, and 12 months after crown placement
Clinical success of prefabricated crowns is evaluated according to the World Dental Federation clinical evaluation criteria (FDI). Functional properties include crown retention and material loss, marginal adaptation, antagonist tooth wear, and occlusal height of the crown. Esthetic properties include surface roughness, color match, and anatomical form. Biological properties include periodontal health. Overall clinical performance is assessed at each follow-up visit.
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 23 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient confidentiality concerns. The study involves pediatric participants, and all data will be analyzed and reported in aggregate form to ensure privacy and compliance with ethical standards.
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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 Zirconia Crown and Prefabricated Nanohybrid Composite Crown in people with Dental Caries in Primary Teeth and Full-Coverage Restorations in Pediatric Dentistry, run by Izmir Katip Celebi 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 12 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: finished, as of the sponsor's last update on 23 Feb 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?
Clinical Success of Prefabricated Crowns Based on FDI Criteria (time frame: 3, 6, 9, and 12 months after crown placement). 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 23 Feb 2026.