- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06960070
- Original Trial
Clinical Success of Onlays Fabricated With Different Types of Resin
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Esra Cengiz Yanardag, DDS, PhD
- Phone Number: +905052443472
- Email: esracengiz@mersin.edu.tr
Study Locations
-
-
Mersin
-
Mersin, Mersin, Turkey (Türkiye), 33150
- Recruiting
- Mersin University Faculty of Dentistry
-
Principal Investigator:
- Esra Cengiz Yanardag, DDS, PhD
-
Contact:
- Esra Cengiz Yanardag, DDS, PhD
- Phone Number: 05052443472
- Email: esracengiz@mersin.edu.tr
-
Contact:
- Email: esracengiz@mersin.edu.tr
-
Mersin, Mersin, Turkey (Türkiye), 33343
- Not yet recruiting
- Mersin University
-
Contact:
- Esra Cengiz Yanardag, DDS, PhD
- Phone Number: 0905052443472
- Email: esracengiz@mersin.edu.tr
-
Contact:
- Ezgi Guven, DDS
- Phone Number: 0905307734677
- Email: guvenezgi6@gmail.com
-
Principal Investigator:
- Esra Cengiz Yanardag, DDS, PhD
-
Sub-Investigator:
- Ezgi Guven, DDS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Saremco print resin
|
The teeth were restored with Saremco print resin via Asiga Max printer according to the manufacturer's instructions.
|
|
Active Comparator: Varseosmile Crownplus resin
|
The teeth were restored with Varseosmile Crownplus resin via Asiga Max printer according to the manufacturer's instructions.
|
|
Active Comparator: Varseosmile TriniQ resin
|
The teeth were restored with Varseosmile TriniQ resin via Asiga MAx printer according to the manufacturer' instructions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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:
|
Baseline- 6 months-12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025/364
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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