One-year Clinical Evaluation of Onlay Restorations Fabricated With Three Different Additive Manufacturing Resins in Endodontically Treated Teeth: A Prospective Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Mersin University
- Enrollment
- 48
- Locations
- 2
- Primary Endpoint
- Clinical performance
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 84 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Saremco print resin
Intervention: Saremco print resin (Device)
Varseosmile Crownplus resin
Intervention: Varseosmile Crownplus resin (Device)
Varseosmile TriniQ resin
Intervention: Varseosmile TriniQ resin (Device)
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Esra Cengiz Yanardag
Professor
Mersin University
