3d Printing Ceramic RestorationNCT07228572
Clinical Evaluation of Three-Dimensional (3D) Printing Resin Nanoceramic Crown Restoration.
A study testing 3D printing hybrid ceramic crown restorations in people with 3d Printing Ceramic Restoration and Nanoceramic Crown Restoration for Posterior Teeth, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the function and aesthetics of ceramic-filled hybrid resin permanent crowns produced by 3D printing method in posterior teeth according to Revised FDI criteria. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- 3d Printing Ceramic Restoration, Nanoceramic Crown Restoration for Posterior Teeth
- What is being tested?
- 3D printing hybrid ceramic crown restorations
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jun 2025to Jan 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals between 18 and 65 years of age, Patients requiring a single crown restoration in the posterior region of the maxilla or mandible, Absence of active periodontal disease, Presence of an opposing tooth (natural or restored), Presence of adjacent teeth (mesial and distal), Vital or endodontically treated (devital) teeth without periapical lesions, Patients who agree to comply with the study conditions will be included in the study.
Who cannot join
- Suspected or confirmed pregnancy, or patients in the breastfeeding period, Teeth requiring coverage that are intended to serve as abutments for fixed partial dentures, Vital or endodontically treated (devital) teeth with periapical lesions, Absence of an opposing tooth or presence of an opposing tooth restored with a crown, Absence of adjacent teeth (mesial or distal), Individuals with temporomandibular joint disorders (TMDs), patients who do not consent to the study conditions will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University, Faculty of Dentistry, Department of Prosthodontics
Izmir, İzmir, 35040
About this study
Official title: Clinical Evaluation of Resin Nanoceramic Crown Restoration for Posterior Teeth Fabricated by Three-Dimensional (3D) Printing: Short-Term Clinical Study
This study aims to evaluate the function and aesthetics of ceramic-filled hybrid resin permanent crowns produced by 3D printing method in posterior teeth according to Revised FDI criteria.
At the Department of Prosthodontics, Faculty of Dentistry, Ege University, 60 patients who present for single-tooth crown restoration in the posterior region of either the maxilla or mandible and who meet the inclusion criteria will receive a total of 60 permanent crown restorations. Following tooth preparation, the restorations will be fabricated using a three-dimensional (3D) printing technique with a ceramic-filled hybrid resin material (VarseoSmile TriniQ, Bego, Bremen, Germany).
The effects of restorations on clinical success will be evaluated according to demographic data (age, gender, etc.) and modified USPHS and Revised FDI criteria, and statistical analysis will be applied to the recorded data. Follow-up visits are scheduled at 0: baseline, 6, and 12 months.
Read the detailed description
The study will be conducted between June 2025 and June 2026. Tooth preparation will be performed following clinical and radiographic examinations. The study schedule will be explained in detail to all patients included in the study.
According to the power analysis performed (G*Power Ver. 3.0.10), at a significance level of p= 0.05, the inclusion of at least 16 patients was determined to be necessary to achieve a statistical power of at least 80%. To further increase the power of the study, it was planned to include 60 patients who meet the inclusion criteria.
Eligible patients will be provided with detailed and comprehensible information regarding the content of the study. Subsequently, the informed consent form will be presented and read, and any questions from the patient will be addressed. If the patient agrees to participate in the study, the form will be signed.
Prosthetic treatment phase:
In the clinics of the Department of Prosthodontics, Faculty of Dentistry, Ege University, following completion of tooth preparation, crown restorations will be fabricated from a ceramic-filled permanent hybrid resin material (VarseoSmile TriniQ, Bego, Bremen, Germany) using a 3D printing technique, based on intraoral optical scans obtained with an intraoral scanner (iTero 5D Element Plus, Align Technology, USA). The restorations will be cemented with a self-adhesive resin cement Panavia V5 Standard Kit (Kuraray Noritake, Osaka, Japan). Occlusion will be checked, and patients will be provided with routine oral hygiene instructions.
Clinical and radiographic evaluations of 3D-printed crowns will be performed at 6 and 12 months. Data will be recorded according to the revised FDI criteria and modified united states public health service USPHS criteria.
At each follow-up visit, patients' teeth will be scanned using intraoral scanner (iTero 5D Element Plus, Align Technology, USA). The STL files of scans will be superimposed using Geomagic software, and the wear will be evaluated.
- Being tested
- 3D printing hybrid ceramic crown restorations
- Keywords
- nanoceramic crown, 3d printed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printing hybrid ceramic crown restorationsOther
crown restorations fabricated with 3D printing nanoceramic will be applied to 60 patients. following the 6 and 12 month follow-ups, the collected data will be analyzed according to clinical evaluation criteria.
| Study group | Role | What they receive |
|---|---|---|
| nanoceramic crown restorations ; clinical evolution | Experimental | the crown preparation for the tooth of each patient included in the study will be perfomered using preparation bur set under water cooling with a rotary handpiece. then digital impression of the prepared teeth will be obtained using an intra-oral scanner to facilitate the design of crown restorations. following their design and fabrication, the 3d printed nanoceramic crown restorations will be adhesively cemented to the teeth after verifying their fit. Receives: Other: 3D printing hybrid ceramic crown restorations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revised FDI criteria for evaluating direct and indirect dental restorations
In 2007, an international workgroup published new FDI criteria to evaluate the quality of direct and indirect restorations; an update with clinical cases was published in 2010. Then, these criteria are revised in 2022. This diagnostic system classified aesthetic, functional, and biological properties and covers various types of failures by using 16 different categories with five grades for each criterion. In detail, scores 1 to 3 indicated clinically acceptable restorations, and scores 4 and 5 summarized clinically unacceptable situations indicating repair (score 4) or replacement (score 5).
Measured: one year
Modified united states public health service (USPHS) criteria
The clinical performance of crown restorations are evaluated by using USPHS criteria. Parameters such as color match, anatomic form, marginal integrity, surface roughness, retention and post-operative sensitivity are assessed. Each parameter is scored using Alpha, Bravo and Charlie ratings. Alpha indicates to optimal clinical performance, Bravo rating is for an acceptable level and Charlie rating represents the need for restoration repair or replacement.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start26 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 3d Printing Ceramic RestorationStudies of the same condition, open and under way.
- More trials run by Ege 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- case - control study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- Ege University Scientific Research Projects Coordination
- Responsible party
- Principal investigator, ola salama, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228572
- Sponsor's protocol ID
- EGE-DHF-OS-01
- Status last verified
- Oct 2026
- First submitted
- 13 Nov 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Resin Nanoceramic Crown Restoration for Posterior Teeth Fabricated by Three-Dimensional (3D) Printing: Short-Term Clinical Study
- ClinicalTrials.gov ID
- NCT07228572
- Acronym / sponsor ID
- EGE-DHF-OS-01
- Keywords
- nanoceramic crown, 3d printed
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- Ege University Scientific Research Projects Coordination
- Study start
- 26 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 14 Nov 2025 (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 evaluate the function and aesthetics of ceramic-filled hybrid resin permanent crowns produced by 3D printing method in posterior teeth according to Revised FDI criteria.
At the Department of Prosthodontics, Faculty of Dentistry, Ege University, 60 patients who present for single-tooth crown restoration in the posterior region of either the maxilla or mandible and who meet the inclusion criteria will receive a total of 60 permanent crown restorations. Following tooth preparation, the restorations will be fabricated using a three-dimensional (3D) printing technique with a ceramic-filled hybrid resin material (VarseoSmile TriniQ, Bego, Bremen, Germany).
The effects of restorations on clinical success will be evaluated according to demographic data (age, gender, etc.) and modified USPHS and Revised FDI criteria, and statistical analysis will be applied to the recorded data. Follow-up visits are scheduled at 0: baseline, 6, and 12 months.
Detailed description
The study will be conducted between June 2025 and June 2026. Tooth preparation will be performed following clinical and radiographic examinations. The study schedule will be explained in detail to all patients included in the study.
According to the power analysis performed (G*Power Ver. 3.0.10), at a significance level of p= 0.05, the inclusion of at least 16 patients was determined to be necessary to achieve a statistical power of at least 80%. To further increase the power of the study, it was planned to include 60 patients who meet the inclusion criteria.
Eligible patients will be provided with detailed and comprehensible information regarding the content of the study. Subsequently, the informed consent form will be presented and read, and any questions from the patient will be addressed. If the patient agrees to participate in the study, the form will be signed.
Prosthetic treatment phase:
In the clinics of the Department of Prosthodontics, Faculty of Dentistry, Ege University, following completion of tooth preparation, crown restorations will be fabricated from a ceramic-filled permanent hybrid resin material (VarseoSmile TriniQ, Bego, Bremen, Germany) using a 3D printing technique, based on intraoral optical scans obtained with an intraoral scanner (iTero 5D Element Plus, Align Technology, USA). The restorations will be cemented with a self-adhesive resin cement Panavia V5 Standard Kit (Kuraray Noritake, Osaka, Japan). Occlusion will be checked, and patients will be provided with routine oral hygiene instructions.
Clinical and radiographic evaluations of 3D-printed crowns will be performed at 6 and 12 months. Data will be recorded according to the revised FDI criteria and modified united states public health service USPHS criteria.
At each follow-up visit, patients' teeth will be scanned using intraoral scanner (iTero 5D Element Plus, Align Technology, USA). The STL files of scans will be superimposed using Geomagic software, and the wear will be evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- case - control study
| Arm | Type | Receives |
|---|---|---|
| nanoceramic crown restorations ; clinical evolution | Experimental | Other: 3D printing hybrid ceramic crown restorationsthe crown preparation for the tooth of each patient included in the study will be perfomered using preparation bur set under water cooling with a rotary handpiece. then digital impression of the prepared teeth will be obtained using an intra-oral scanner to facilitate the design of crown restorations. following their design and fabrication, the 3d printed nanoceramic crown restorations will be adhesively cemented to the teeth after verifying their fit. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals between 18 and 65 years of age, Patients requiring a single crown restoration in the posterior region of the maxilla or mandible, Absence of active periodontal disease, Presence of an opposing tooth (natural or restored), Presence of adjacent teeth (mesial and distal), Vital or endodontically treated (devital) teeth without periapical lesions, Patients who agree to comply with the study conditions will be included in the study.
Key exclusion criteria (1 listed)
- Suspected or confirmed pregnancy, or patients in the breastfeeding period, Teeth requiring coverage that are intended to serve as abutments for fixed partial dentures, Vital or endodontically treated (devital) teeth with periapical lesions, Absence of an opposing tooth or presence of an opposing tooth restored with a crown, Absence of adjacent teeth (mesial or distal), Individuals with temporomandibular joint disorders (TMDs), patients who do not consent to the study conditions will be excluded from the study.
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 |
|---|---|---|
| 3D printing hybrid ceramic crown restorationscrown restorations fabricated with 3D printing nanoceramic will be applied to 60 patients. following the 6 and 12 month follow-ups, the collected data will be analyzed according to clinical evaluation criteria. | Other | nanoceramic crown restorations ; clinical evolution |
Primary outcome
Revised FDI criteria for evaluating direct and indirect dental restorations
Time frame: one year
In 2007, an international workgroup published new FDI criteria to evaluate the quality of direct and indirect restorations; an update with clinical cases was published in 2010. Then, these criteria are revised in 2022. This diagnostic system classified aesthetic, functional, and biological properties and covers various types of failures by using 16 different categories with five grades for each criterion. In detail, scores 1 to 3 indicated clinically acceptable restorations, and scores 4 and 5 summarized clinically unacceptable situations indicating repair (score 4) or replacement (score 5).
Modified united states public health service (USPHS) criteria
Time frame: one year
The clinical performance of crown restorations are evaluated by using USPHS criteria. Parameters such as color match, anatomic form, marginal integrity, surface roughness, retention and post-operative sensitivity are assessed. Each parameter is scored using Alpha, Bravo and Charlie ratings. Alpha indicates to optimal clinical performance, Bravo rating is for an acceptable level and Charlie rating represents the need for restoration repair or replacement.
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 2 Oct 2026.
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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 3D printing hybrid ceramic crown restorations in people with 3d Printing Ceramic Restoration and Nanoceramic Crown Restoration for Posterior Teeth, run by Ege 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 2 Oct 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?
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?
Revised FDI criteria for evaluating direct and indirect dental restorations (time frame: one year). The study lists 2 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 2 Oct 2026.