A Randomized Split-mouth Clinical Trial of Partial Laminate Veneers Bonded With Two Different Resin Composite Luting Agents
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Universidad Arturo Prat
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Survival Data of Partial Laminate Veneers bonded with Conventional Resin Cement and Preheated Resin Composite
Study Overview
Brief Summary
Partial laminate veneers is a type of dental restoration made of a glass-matrix ceramic used to restore small teeth fractures, or to correct morphology defects of teeth (i.e.: diastema, conoid teeth or small misalignment). As tooth surface reduction, or tooth preparation is not needed for this type of restoration, it can be considered as a non-tooth preparation minimally invasive procedure.
As non-preparation is required for the restoration with ceramic partial laminate veneers, bonding relies on adhesion between the intaglio surface of the ceramic restoration and the tooth surface, which in most of the cases is enamel. For this purpose, many light-curing resin cement materials are available for bonding procedures. Nowadays, pre-heated resin composites are available as a resin luting material which has been indicated for laminate veneers and partial indirect posterior restorations.
As pre-heated resin composite has not been yet studied for partial laminate veneers, the objective of this randomized split mouth clinical trial, is to evaluate the survival of ceramic partial laminate veneers when bonded with two different resin composite luting agents.
Detailed Description
Patients will be recruited starting the 18th of April 2024. Patients willing to enroll in this study must be over 18 years old, capable to read and sign an informed consent, willing to come back to checkups, with periodontal and pulpal health, having anterior teeth with the need of minimal morphology corrections like diastema, conoid teeth or misaligned teeth, and small fractures. Non vital teeth were not excluded. Patients will poor oral hygiene, active caries lesions are excluded.
Pre Operative Procedures. Informed consent will be given first and ask for every patient to sign it. Face and intraoral photographs will be taken. Initial polyvinylsiloxane (PVS) impressions will be performed and sent to the dental laboratory for wax-up from a digital planning analysis. Prophylaxis, new restorations, endodontic treatment and gingival surgery will be performed based on a mock-up made from bis-acrylic material.
Tooth preparation Most cases won't have tooth surface reduction or preparation. Some cases will need smoothening of the sharp angles or enamel irregularities to prevent fractures during restoration try-in. New impression will be performed with PVS impression material to obtain working models for the elaboration of ceramic partial laminate veneers (PLV) One dental technician will elaborate all the PLV according to the manufacturer instructions.
Adhesive luting procedures. Seating, adaptation and form will be checked firt. Try-in pastes will be used to control shade match of the restorations that will be adhesively luted with Variolink Esthetic (conventional light-curing resin cement), while polarized photography of a small amount of polymerized resin composite will be taken for color selection of the preheated resin composite luting agent (Enamel Plus HFO).
Intaglio surfaces of the ceramic restorations protocol:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
two observers will evaluate clinically patient's restorations using the modified USPHS criteria and the FDI criteria. Observers will be blinded to the type of luting agent used for the restoration with ceramic partial laminate veneers
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients over 18 years
- •Patients able to read and sign an informed consent.
- •Patients willing to come back to check-ups.
- •Patients without active caries lesions or periodontal disease.
- •Patients that need to restore their anterior maxillary teeth (upper incisors or canines) due to small fractures, misaligned teeth, conoid teeth or diastema.
- •Non-vital teeth will also be included.
Exclusion Criteria
- •Patients with active caries lesions or periodontal disease.
- •Patients with occlusal disfunction or uncontrolled parafunctional habits.
- •Patients unwilling to come back to checkups.
Arms & Interventions
Patients with PLV
All patients will receive ceramic partial laminate veneers as treatment. As this is a split mouth design, one side of the mouth will receive partial laminate veneers bonded with a conventional light-curing resin cement and the other side of the mouth with a pre-heated resin composite.
Intervention: Conventional Resin Cement vs Preheated Resin Composite (Procedure)
Outcomes
Primary Outcomes
Survival Data of Partial Laminate Veneers bonded with Conventional Resin Cement and Preheated Resin Composite
Time Frame: after 36 months
Survival data will be measured in percentages (0-100%) over the years. Kaplan - Meier curves are used to determine the moment of failure (date, months) Mantel - Cox test will be used to determine differences between the two groups
Secondary Outcomes
No secondary outcomes reported
Investigators
Gerardo Duran Ojeda
Doctor of Dental Surgery
Universidad Arturo Prat