Clinical Trial on Ceramic Partial Laminate Veneers With Different Luting Agents

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05221242
• Other study ID #: 06-07-10-2021
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 4, 2021
• Est. completion date: January 4, 2024

Study information

• Verified date: May 2023
• Source: Universidad Arturo Prat
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Patients will be recruited starting the 4th of January 2021. 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 (Monobond N, Ivoclar Vivadent)

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

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

• Tetric N bond Universal for ceramics that will be bonded with Variolink Esthetic.

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

• Variolink esthetic according to color try-in.

• Enamel Plus HFO will be pre heated in an hoven at 59ºC.

6. - Store the restorations of light exposure.

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

1. - Apply 35% phosphoric acid for 15 seconds in enamel and 3-5seconds in dentin.

2. - rinse profusely with water for 30 seconds.

3. - air-dry

4. - apply adhesive on tooth surface:

• Dentin (if exposed): with Optibond FL primer (for restorations that will be bonded with Enamel Plus HFO), and with Tetric N Bond Universal (for restorations that will be bonded with Variolink Esthetic).

• Enamel: continue with Optibond Adhesive for Enamel Plus HFO, and continue with Tetric N Bond Universal for Variolink Esthetic.

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 (Diacomp Twist Plus, EVE) 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)

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: January 4, 2024
• Est. primary completion date: January 4, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Chile	Clínica Áurea Iquique	Iquique

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Arturo Prat

Country where clinical trial is conducted

Chile, 

References & Publications (9)

Ceinos R, Pouyssegur V, Allard Y, Bertrand MF. Esthetic rehabilitation of the smile with partial laminate veneers in an older adult. Clin Case Rep. 2018 Jun 4;6(8):1407-1411. doi: 10.1002/ccr3.1593. eCollection 2018 Aug. — View Citation

Elter B, Aladag A, Comlekoglu ME, Dundar Comlekoglu M, Kesercioglu AI. Colour stability of sectional laminate veneers: A laboratory study. Aust Dent J. 2021 Sep;66(3):314-323. doi: 10.1111/adj.12837. Epub 2021 Apr 7. — View Citation

Farias-Neto A, Gomes EM, Sanchez-Ayala A, Sanchez-Ayala A, Vilanova LS. Esthetic Rehabilitation of the Smile with No-Prep Porcelain Laminates and Partial Veneers. Case Rep Dent. 2015;2015:452765. doi: 10.1155/2015/452765. Epub 2015 Oct 18. — View Citation

Gresnigt M, Ozcan M. Esthetic rehabilitation of anterior teeth with porcelain laminates and sectional veneers. J Can Dent Assoc. 2011;77:b143. — View Citation

Gresnigt MM, Kalk W, Ozcan M. Randomized controlled split-mouth clinical trial of direct laminate veneers with two micro-hybrid resin composites. J Dent. 2012 Sep;40(9):766-75. doi: 10.1016/j.jdent.2012.05.010. Epub 2012 Jun 2. — View Citation

Gresnigt MMM, Sugii MM, Johanns KBFW, van der Made SAM. Comparison of conventional ceramic laminate veneers, partial laminate veneers and direct composite resin restorations in fracture strength after aging. J Mech Behav Biomed Mater. 2021 Feb;114:104172. doi: 10.1016/j.jmbbm.2020.104172. Epub 2020 Nov 4. — View Citation

Horvath S, Schulz CP. Minimally invasive restoration of a maxillary central incisor with a partial veneer. Eur J Esthet Dent. 2012 Spring;7(1):6-16. — View Citation

Signore A, Kaitsas V, Tonoli A, Angiero F, Silvestrini-Biavati A, Benedicenti S. Sectional porcelain veneers for a maxillary midline diastema closure: a case report. Quintessence Int. 2013 Mar;44(3):201-6. doi: 10.3290/j.qi.a29058. — View Citation

Sinhori BS, Monteiro S Jr, Bernardon JK, Baratieri LN. CAD/CAM ceramic fragments in anterior teeth: A clinical report. J Esthet Restor Dent. 2018 Mar;30(2):96-100. doi: 10.1111/jerd.12342. Epub 2017 Sep 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Success Data of Partial Laminate Veneers bonded with Conventional Resin Cement and Preheated Resin Composite	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
Other	Assessment of Oral Health Impact Profile	Final outcome with Partial veneers will be measured using the Oral Health Impact Profile.	after 12 months
Primary	Survival Data of Partial Laminate Veneers bonded with Conventional Resin Cement and Preheated Resin Composite	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