Endodontically-Treated TeethNCT06960070
Clinical Success of Onlays Fabricated With Different Types of Resin
A study testing Saremco print resin, Varseosmile Crownplus resin and Varseosmile TriniQ resin in people with Endodontically-Treated Teeth, run by Mersin University at 2 sites in Turkey (Türkiye).
Trial summary
Additive manufacturing, also referred to as "3D printing" or "rapid prototyping," is defined as the process of joining materials layer by layer to create an object based on 3D model data. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Endodontically-Treated Teeth
- What is being tested?
- Saremco print resin, Varseosmile Crownplus resin and Varseosmile TriniQ resin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 18 Jun 2025to 18 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 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Molar teeth that have undergone root canal treatment
- Teeth with proximal defects located above the gingival margin
- Defects limited to the occlusal surface and a single adjacent surface
- Presence of an occlusal defect extending over one-third of the distance between the fissure and the cusp tip and involving one or more cusps
- Presence of an opposing tooth or a fixed prosthetic restoration against the tooth to be restored
- Presence of adjacent teeth next to the tooth to be restored
Who cannot join
- Fractured or cracked teeth
- Patients with temporomandibular joint disorders
- Patients with bruxism (teeth grinding)
- Molar teeth without an opposing tooth or fixed prosthetic restoration
- Molar teeth without adjacent teeth
- Vital teeth
- Patients with a history of allergy to the components of the resins
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Mersin University Faculty of Dentistry
Mersin, Mersin, 33150
Esra Cengiz Yanardag, DDS, PhD, 05052443472, esracengiz@mersin.edu.tr
esracengiz@mersin.edu.tr
- Not yet recruiting
Mersin University
Mersin, Mersin, 33343
Esra Cengiz Yanardag, DDS, PhD, 0905052443472, esracengiz@mersin.edu.tr
Ezgi Guven, DDS, 0905307734677, guvenezgi6@gmail.com
About this study
Official title: One-year Clinical Evaluation of Onlay Restorations Fabricated With Three Different Additive Manufacturing Resins in Endodontically Treated Teeth: A Prospective Study
Additive manufacturing, also referred to as "3D printing" or "rapid prototyping," is defined as the process of joining materials layer by layer to create an object based on 3D model data. In this method, a digital data set is first created on a computer (computer-aided design, CAD) and then transferred to a 3D printer. The designed object is produced by printing it in successive layers.
In contrast, in subtractive manufacturing, restorations are produced by milling homogeneous blocks based on computer-designed models. Compared to subtractive manufacturing technology, additive manufacturing allows for the production of more complex, detailed, and larger structures with much less material waste and without excessive use of force.
Read more
It is thought that additive manufacturing has the potential to overcome the disadvantages of subtractive manufacturing. Over the past decade, global sales of industrial and personal 3D printers, materials, and services have increased by more than 33% annually.
Due to its success in the production of surgical guides, temporary and permanent restorations, crowns and bridges, occlusal splints, frameworks, and orthodontic appliances, this technology has attracted significant interest in the field of dentistry.
Although additive manufacturing has started to be used as an alternative to subtractive manufacturing in many applications, there is still a lack of information regarding the chemical composition, mechanical, and physical properties of printable resins. Moreover, clinical data on the use of these resins in permanent restorations are quite limited.
Therefore, the aim of this study is to clinically evaluate and monitor for one year the performance of onlay restorations fabricated with three different resins of varying compositions in endodontically treated teeth.
- Conditions
- Endodontically-Treated Teeth
- Being tested
- Saremco print resin, Varseosmile Crownplus resin, Varseosmile TriniQ resin
- Keywords
- onlay, endodontically -reated teeth, indirect restoration, additively manufactured, hybrid resin
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saremco print resinDevice
The teeth were restored with Saremco print resin via Asiga Max printer according to the manufacturer's instructions.
Varseosmile Crownplus resinDevice
The teeth were restored with Varseosmile Crownplus resin via Asiga Max printer according to the manufacturer's instructions.
Varseosmile TriniQ resinDevice
The teeth were restored with Varseosmile TriniQ resin via Asiga MAx printer according to the manufacturer' instructions
| Study group | Role | What they receive |
|---|---|---|
| Saremco print resin | Active comparator | Not described Receives: Device: Saremco print resin |
| Varseosmile Crownplus resin | Active comparator | Not described Receives: Device: Varseosmile Crownplus resin |
| Varseosmile TriniQ resin | Active comparator | Not described Receives: Device: Varseosmile TriniQ resin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance
The clinical evaluation of restorations bonded to teeth will be performed at baseline, at 6 months, and at 12 months using the World Dental Federation (FDI) criteria which are divided into 3 main categories as functional, biological and esthetic properties. Each property is typically scored on a 1 to 5 scale:
- - Clinically excellent
- - Clinically good
- - Clinically sufficient
- - Clinically insufficient
- - Clinically poor
Measured: Baseline- 6 months-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start18 Jun 2025
- Primary completion18 Dec 2026 (estimated)
- Study completion18 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontically-Treated TeethStudies of the same condition, open and under way.
- More trials run by Mersin 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Cengiz Yanardag, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960070
- Sponsor's protocol ID
- 2025/364
- Status last verified
- Sep 2025
- First submitted
- 18 Apr 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-year Clinical Evaluation of Onlay Restorations Fabricated With Three Different Additive Manufacturing Resins in Endodontically Treated Teeth: A Prospective Study
- ClinicalTrials.gov ID
- NCT06960070
- Acronym / sponsor ID
- 2025/364
- Conditions
- Endodontically-Treated Teeth
- Keywords
- onlay, endodontically -reated teeth, indirect restoration, additively manufactured, hybrid resin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 18 Dec 2026 (estimated)
- Study completion
- 18 Jun 2027 (estimated)
- First posted
- 7 May 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.
Additive manufacturing, also referred to as "3D printing" or "rapid prototyping," is defined as the process of joining materials layer by layer to create an object based on 3D model data. In this method, a digital data set is first created on a computer (computer-aided design, CAD) and then transferred to a 3D printer. The designed object is produced by printing it in successive layers.
In contrast, in subtractive manufacturing, restorations are produced by milling homogeneous blocks based on computer-designed models. Compared to subtractive manufacturing technology, additive manufacturing allows for the production of more complex, detailed, and larger structures with much less material waste and without excessive use of force.
It is thought that additive manufacturing has the potential to overcome the disadvantages of subtractive manufacturing. Over the past decade, global sales of industrial and personal 3D printers, materials, and services have increased by more than 33% annually.
Due to its success in the production of surgical guides, temporary and permanent restorations, crowns and bridges, occlusal splints, frameworks, and orthodontic appliances, this technology has attracted significant interest in the field of dentistry.
Although additive manufacturing has started to be used as an alternative to subtractive manufacturing in many applications, there is still a lack of information regarding the chemical composition, mechanical, and physical properties of printable resins. Moreover, clinical data on the use of these resins in permanent restorations are quite limited.
Therefore, the aim of this study is to clinically evaluate and monitor for one year the performance of onlay restorations fabricated with three different resins of varying compositions in endodontically treated teeth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Saremco print resin | Active comparator | Device: Saremco print resin |
| Varseosmile Crownplus resin | Active comparator | Device: Varseosmile Crownplus resin |
| Varseosmile TriniQ resin | Active comparator | Device: Varseosmile TriniQ resin |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Molar teeth that have undergone root canal treatment
- Teeth with proximal defects located above the gingival margin
- Defects limited to the occlusal surface and a single adjacent surface
- Presence of an occlusal defect extending over one-third of the distance between the fissure and the cusp tip and involving one or more cusps
- Presence of an opposing tooth or a fixed prosthetic restoration against the tooth to be restored
Key exclusion criteria (7 listed)
- Fractured or cracked teeth
- Patients with temporomandibular joint disorders
- Patients with bruxism (teeth grinding)
- Molar teeth without an opposing tooth or fixed prosthetic restoration
- Molar teeth without adjacent 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 |
|---|---|---|
| Saremco print resinThe teeth were restored with Saremco print resin via Asiga Max printer according to the manufacturer's instructions. | Device | Saremco print resin |
| Varseosmile Crownplus resinThe teeth were restored with Varseosmile Crownplus resin via Asiga Max printer according to the manufacturer's instructions. | Device | Varseosmile Crownplus resin |
| Varseosmile TriniQ resinThe teeth were restored with Varseosmile TriniQ resin via Asiga MAx printer according to the manufacturer' instructions | Device | Varseosmile TriniQ resin |
Primary outcome
Clinical performance
Time frame: Baseline- 6 months-12 months
The clinical evaluation of restorations bonded to teeth will be performed at baseline, at 6 months, and at 12 months using the World Dental Federation (FDI) criteria which are divided into 3 main categories as functional, biological and esthetic properties. Each property is typically scored on a 1 to 5 scale: 1. - Clinically excellent 2. - Clinically good 3. - Clinically sufficient 4. - Clinically insufficient 5. - Clinically poor
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 10 Sep 2025.
- Individual participant dataSharing planned: Yes
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saremco print resin, Varseosmile Crownplus resin and Varseosmile TriniQ resin in people with Endodontically-Treated Teeth, run by Mersin University at 2 sites 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 6 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: looking for participants now, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Esra Cengiz Yanardag, DDS, PhD (+905052443472, esracengiz@mersin.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical performance (time frame: Baseline- 6 months-12 months). 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 10 Sep 2025.