Clinical Success of Onlays Fabricated With Different Types of Resin

NCT06960070 | Recruiting DMC

• 1 other identifier: 2025/364
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Endodontically-Treated Teeth

Keywords

onlay; endodontically -reated teeth; indirect restoration; additively manufactured; hybrid resin

Outcome Measures

Primary Outcomes (1)

• 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: 1. \- Clinically excellent 2. \- Clinically good 3. \- Clinically sufficient 4. \- Clinically insufficient 5. \- Clinically poor

  Baseline- 6 months-12 months

Study Arms (3)

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

Interventions

Saremco print resin DEVICE

The teeth were restored with Saremco print resin via Asiga Max printer according to the manufacturer's instructions.

Saremco print resin

Varseosmile Crownplus resin DEVICE

The teeth were restored with Varseosmile Crownplus resin via Asiga Max printer according to the manufacturer's instructions.

Varseosmile Crownplus resin

Varseosmile TriniQ resin DEVICE

The teeth were restored with Varseosmile TriniQ resin via Asiga MAx printer according to the manufacturer' instructions

Varseosmile TriniQ resin

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mersin University: lead

Study Sites (2)

Mersin University Faculty of Dentistry

Mersin, Mersin, 33150, Turkey (Türkiye)

RECRUITING

Mersin University

Mersin, Mersin, 33343, Turkey (Türkiye)

NOT YET RECRUITING

MeSH Terms

Conditions

Tooth, Nonvital

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Esra Cengiz Yanardag, DDS, PhD

CONTACT

+905052443472; esracengiz@mersin.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: May 7, 2025
• Study Start: June 18, 2025
• Primary Completion (Estimated): December 18, 2026
• Study Completion (Estimated): June 18, 2027
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

TU (2)