Clinical Trial on Ceramic Partial Laminate Veneers With Different Luting Agents

June 28, 2024 updated by: Gerardo Duran Ojeda, Universidad Arturo Prat

A Randomized Split-mouth Clinical Trial of Partial Laminate Veneers Bonded With Two Different Resin Composite Luting Agents

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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:

  1. - Application of 9,5% hydrofluoric acid for 120 seconds.
  2. - 1 minute of water rinsing. 5 minutes of ultrasonic bath cleaning with distilled water.
  3. - Silane application

  4. - Bonding Application (without light-curing):

    • Optibond Fl adhesive for ceramics that will be bonded with Enamel Plus HFO.

  5. - Charge of resin cement (without light-curing)

    • Variolink esthetic according to color try-in.
    • Enamel Plus HFO will be pre heated in a resin heater at 69ºC.
  6. - Store the restorations of light exposure.

Surface treatment of enamel and dentin (if dentin is exposed):

  1. - Apply phosphoric acid for 15 seconds in enamel.
  2. - rinse profusely with water for 30 seconds.
  3. - air-dry
  4. - apply adhesive on tooth surface.
  5. - No light-curing.

Restorations will be seated with small finger pressure, excesses of resin cement will be eliminated using brushes. Light-curing will be then performed using soft mode of approximately 650mw/cm2 during 3-5 seconds. A final light-curing in high mode will be performed after 3-5 minutes of waiting at approximately 1200 mw/cm2.

Polishing procedure All restorations will be polished with 2-step diamond spiral wheels under water irrigation.

Evaluation 2 blind observers to the luting procedure performed will evaluate clinically the restorations using the modified USPHS criteria and the FDI (World Dental Federation) criteria for the evaluation of direct and indirect restorations. Also an Impact in Oral Health questionary will be applied to determine the esthetic perception of the applied treatment.

modified USPHS criteria and FDI criteria will be applied at baseline after luting the restorations and every 6 months until a completion of minimum of 24 months.

Impact in Oral Health questionary will be applied at baseline and 6 months after the treatment.

Scanning Electron Microscopy evaluation Every case will receive final impressions immediately after the treatment, and after 24 months to evaluate marginal adaptation under Scanning electron microscopy. Fractography Analysis will be performed of every failure or fracture of the restoration.

Statistical analysis Survival will be measure in percentages. Differences will be measure between baseline and final control.

Kaplan-Meier curves will be used to measure cumulative survival, and log rank (Mantel-Cox) to determine differences between the two groups (bonded with conventional resin cement vs pre heated resin composite)

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Iquique, Chile, 1101128
        • Clínica Áurea Iquique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Conventional Resin Cement vs Preheated Resin Composite
For this study, variolink esthetic resin cement will be used to bond ceramic partial laminate veneers in one side of the maxillary anterior teeth (left or right upper incisors and canines), while, the other side will receive ceramic partial laminate veneers bonded with a preheated resin composite
Other Names:
  • Variolink Esthetic (Ivoclar Vivadent, Schaan, Liechtenstein)
  • Enamel Plus HFO (Micerium, Avegno, Italy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
after 36 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success Data of Partial Laminate Veneers bonded with Conventional Resin Cement and Preheated Resin Composite
Time Frame: after 36 months
Success will be clinically evaluated using the modified USPHS criteria and the FDI criteria. This criteria are used to evaluate the need of refurbishment, repair or replacement of a restoration using different categories. Scores in FDI criteria range from 1-5 with 1-3 acceptable, 4 un-acceptable but repairable and 5 need for repair.
after 36 months
Assessment of Oral Health Impact Profile
Time Frame: after 12 months
Final outcome with Partial veneers will be measured using the Oral Health Impact Profile.
after 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Arturo Prat

Collaborators

Universidad de Concepcion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2024

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

January 31, 2025

Study Registration Dates

First Submitted

January 10, 2022

First Submitted That Met QC Criteria

January 22, 2022

First Posted (Actual)

February 2, 2022

Study Record Updates

Last Update Posted (Actual)

July 1, 2024

Last Update Submitted That Met QC Criteria

June 28, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 06-07-10-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The information of patients will be private and not shared. Only researchers included in the Study will be authorized to access patient's data.

Blind observers won't be able to access patients data to reduce bias.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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