CAD/CAM Space MaintainerNCT07057401
Evaluation of Clinical Wear and Surface Roughness of Partial Restorations Produced by Additive and Subtractive Manufacturing Methods: A Split-Mouth Randomized Controlled Clinical Trial
A study testing CAD-CAM Manufactured Crowns and 3D Printed Crowns in people with CAD/CAM Space Maintainer and 3D Printing, run by Husna Selinay at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the surface roughness and wear values of crowns fabricated using currently utilized 3D printing and CAD-CAM technologies. In recent years, crown restorations produced with CAD-CAM systems have been safely used in dentistry. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- CAD/CAM Space Maintainer, 3D Printing, Dental Treatment
- What is being tested?
- CAD-CAM Manufactured Crowns and 3D Printed Crowns
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2025to 20 Jun 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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Teeth with Devital and Vital Cusp Loss
Who cannot join
- Root Canal Treated Teeth with Lesions
- Symptomatic Vital Teeth
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
HÜSNA SELİNAY S dağdelen, Research Assistant contact
About this study
Official title: Investigation of Clinical Wear and Surface Roughness of Partial Restorations Fabricated Using Additive and Subtractive Manufacturing Methods: A Split-Mouth Randomized Controlled Clinical Trial
The aim of this study is to compare the surface roughness and wear values of crowns fabricated using currently utilized 3D printing and CAD-CAM technologies.
In recent years, crown restorations produced with CAD-CAM systems have been safely used in dentistry. These types of restorative materials are expected not to undergo significant wear themselves and also not to cause wear on natural teeth. Therefore, the structural resistance and hardness of the material are clinically very important. Restorations produced using 3D printing are among the latest technological developments in dentistry.
Read more
Additive manufacturing has been defined by the American Society for Testing and Materials (ASTM) as "the process of joining materials layer upon layer to make objects from 3D model data, as opposed to subtractive manufacturing methodologies."
3D printers have started to be used in various disciplines of dentistry such as dental education, oral surgery, dental implantology, orthodontics, pedodontics, prosthodontics, and restorative dentistry. In restorative clinics, they can especially be used in intracoronal restorations. However, studies in this area are quite limited.
The objective of this study is to evaluate the wear values using a Geomagic 3X device and the surface roughness values using a profilometer device over a 12-month period on single crown restorations applied to permanent first molars fabricated by CAD-CAM and 3D printing techniques.
A total of 26 single crown restorations will be performed on first molars. Participants will be selected among individuals aged 18-50 who apply to the Department of Restorative Dentistry, Faculty of Dentistry, Çukurova University. Eligible individuals must be systemically healthy, have no periodontal attachment loss, have an indication for crown restoration, and have a natural opposing tooth in contact with the restored tooth.
Read the detailed description
In today's dentistry, where aesthetics has gained increasing importance, the use of CAD-CAM in the fabrication of fixed prostheses has become widespread.
Although restorations produced by traditional methods are of high quality, they are mechanically and aesthetically affected due to being shaped manually by the dentist (conventional method). Therefore, errors that may occur during fabrication can negatively affect the durability and marginal adaptation of composite restorations.
In a study comparing production techniques, composite crowns produced by the direct technique and single crown restorations fabricated using CAD-CAM were examined under an electron microscope. The composite restorations manufactured with the indirect technique showed more porosity, while no porosity was observed in restorations produced with the CAD-CAM method.
This result may be attributed to the fact that the prefabricated CAD-CAM blocks are homogeneous and subjected to quality control during production. As a result, internal structural defects are generally not observed in milled products. The absence of porosity is an important factor in the durability and fit of restorations.
3D Printers Restorations produced using 3D printers are among the latest technological advancements in dentistry. Additive manufacturing has been defined by the American Society for Testing and Materials (ASTM) as "the process of joining materials layer upon layer to create objects from 3D model data, as opposed to subtractive manufacturing methodologies." 3D printers have begun to be used in various dental disciplines such as dental education, oral surgery, dental implantology, orthodontics, pedodontics, prosthodontics, and restorative dentistry. In restorative clinics, they can especially be utilized for intracoronal restorations. However, studies in this area remain quite limited.
Null hypothesis of this study is that there is no statistically significant difference in clinical wear and surface roughness between single crown indirect restorations fabricated using additive and subtractive manufacturing methods.
- Being tested
- CAD-CAM Manufactured Crowns, 3D Printed Crowns
- Keywords
- subtractive manufacturing, additive manufacturing, roughness, wear
- Medical subject headings
- Stomatognathic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAD-CAM Manufactured CrownsDevice
Single crowns produced using computer-aided design and milling technology applied to permanent molars.
3D Printed CrownsDevice
Single crowns produced using 3D printing technology applied to permanent molars.
| Study group | Role | What they receive |
|---|---|---|
| CAD-CAM Group | Experimental | Participants will receive single crown restorations manufactured by subtractive manufacturing (CAD-CAM milling) techniques. Receives: Device: CAD-CAM Manufactured Crowns |
| 3D Printing Group | Experimental | Participants will receive single crown restorations manufactured by additive manufacturing (3D printing) techniques. Receives: Device: 3D Printed Crowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wear
Measuring wear value using the Geomagic 3X device
Measured: 12 months
Surface roughness
Measuring surface roughness values using a profilometer device
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start20 Sep 2025 (estimated)
- Primary completion20 Jul 2026 (estimated)
- Study completion20 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CAD/CAM Space MaintainerStudies 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
- Evaluation of Wear and Surface Roughness of Partial Crowns Produced by Additive and Subtractive Manufacturing: A 1-Year Randomized Controlled Clinical Trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Husna Selinay
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Husna Selinay, Cukurova University
- Investigators
- ezgi sonkaya akburak, doctor lecturer, Study director, Cukurova University Restorative Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057401
- Sponsor's protocol ID
- Department of Restorative Dent
- Status last verified
- Jul 2025
- First submitted
- 3 Jun 2025
- Last updated
- 9 Jul 2025
- 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 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Clinical Wear and Surface Roughness of Partial Restorations Fabricated Using Additive and Subtractive Manufacturing Methods: A Split-Mouth Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07057401
- Acronym / sponsor ID
- Department of Restorative Dent
- Keywords
- subtractive manufacturing, additive manufacturing, roughness, wear
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Husna SelinayUniversity, hospital or other
- Study start
- 20 Sep 2025 (estimated)
- Primary completion
- 20 Jul 2026 (estimated)
- Study completion
- 20 Jun 2027 (estimated)
- First posted
- 9 Jul 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.
The aim of this study is to compare the surface roughness and wear values of crowns fabricated using currently utilized 3D printing and CAD-CAM technologies.
In recent years, crown restorations produced with CAD-CAM systems have been safely used in dentistry. These types of restorative materials are expected not to undergo significant wear themselves and also not to cause wear on natural teeth. Therefore, the structural resistance and hardness of the material are clinically very important. Restorations produced using 3D printing are among the latest technological developments in dentistry.
Additive manufacturing has been defined by the American Society for Testing and Materials (ASTM) as "the process of joining materials layer upon layer to make objects from 3D model data, as opposed to subtractive manufacturing methodologies."
3D printers have started to be used in various disciplines of dentistry such as dental education, oral surgery, dental implantology, orthodontics, pedodontics, prosthodontics, and restorative dentistry. In restorative clinics, they can especially be used in intracoronal restorations. However, studies in this area are quite limited.
The objective of this study is to evaluate the wear values using a Geomagic 3X device and the surface roughness values using a profilometer device over a 12-month period on single crown restorations applied to permanent first molars fabricated by CAD-CAM and 3D printing techniques.
A total of 26 single crown restorations will be performed on first molars. Participants will be selected among individuals aged 18-50 who apply to the Department of Restorative Dentistry, Faculty of Dentistry, Çukurova University. Eligible individuals must be systemically healthy, have no periodontal attachment loss, have an indication for crown restoration, and have a natural opposing tooth in contact with the restored tooth.
Detailed description
In today's dentistry, where aesthetics has gained increasing importance, the use of CAD-CAM in the fabrication of fixed prostheses has become widespread.
Although restorations produced by traditional methods are of high quality, they are mechanically and aesthetically affected due to being shaped manually by the dentist (conventional method). Therefore, errors that may occur during fabrication can negatively affect the durability and marginal adaptation of composite restorations.
In a study comparing production techniques, composite crowns produced by the direct technique and single crown restorations fabricated using CAD-CAM were examined under an electron microscope. The composite restorations manufactured with the indirect technique showed more porosity, while no porosity was observed in restorations produced with the CAD-CAM method.
This result may be attributed to the fact that the prefabricated CAD-CAM blocks are homogeneous and subjected to quality control during production. As a result, internal structural defects are generally not observed in milled products. The absence of porosity is an important factor in the durability and fit of restorations.
3D Printers Restorations produced using 3D printers are among the latest technological advancements in dentistry. Additive manufacturing has been defined by the American Society for Testing and Materials (ASTM) as "the process of joining materials layer upon layer to create objects from 3D model data, as opposed to subtractive manufacturing methodologies." 3D printers have begun to be used in various dental disciplines such as dental education, oral surgery, dental implantology, orthodontics, pedodontics, prosthodontics, and restorative dentistry. In restorative clinics, they can especially be utilized for intracoronal restorations. However, studies in this area remain quite limited.
Null hypothesis of this study is that there is no statistically significant difference in clinical wear and surface roughness between single crown indirect restorations fabricated using additive and subtractive manufacturing methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Evaluation of Wear and Surface Roughness of Partial Crowns Produced by Additive and Subtractive Manufacturing: A 1-Year Randomized Controlled Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| CAD-CAM Group | Experimental | Device: CAD-CAM Manufactured CrownsParticipants will receive single crown restorations manufactured by subtractive manufacturing (CAD-CAM milling) techniques. |
| 3D Printing Group | Experimental | Device: 3D Printed CrownsParticipants will receive single crown restorations manufactured by additive manufacturing (3D printing) techniques. |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Teeth with Devital and Vital Cusp Loss
Key exclusion criteria (2 listed)
- Root Canal Treated Teeth with Lesions
- Symptomatic Vital Teeth
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 |
|---|---|---|
| CAD-CAM Manufactured CrownsSingle crowns produced using computer-aided design and milling technology applied to permanent molars. | Device | CAD-CAM Group |
| 3D Printed CrownsSingle crowns produced using 3D printing technology applied to permanent molars. | Device | 3D Printing Group |
Primary outcome
Wear
Time frame: 12 months
Measuring wear value using the Geomagic 3X device
Surface roughness
Time frame: 12 months
Measuring surface roughness values using a profilometer device
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 9 Jul 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
HÜSNA SELİNAY S dağdelen, Research Assistant contact
ezgi sonkaya akburak, doctor lecturer study director
Cukurova University Restorative Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAD-CAM Manufactured Crowns and 3D Printed Crowns in people with CAD/CAM Space Maintainer and 3D Printing, run by Husna Selinay 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 2 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: opening soon, as of the sponsor's last update on 9 Jul 2025. 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?
Contact HÜSNA SELİNAY S dağdelen, Research Assistant (+905453051080 ext. 05453051080, selinay428@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wear (time frame: 12 months). 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 9 Jul 2025.