Clinical Trial on Ceramic Partial Laminate Veneers With Different Luting Agents

NCT05221242 | Enrolling By Invitation

• 1 other identifier: 06-07-10-2021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

partial laminate veneers; sectional veneers; ceramic fragments

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (2)

• Success Data of Partial Laminate Veneers bonded with Conventional Resin Cement and Preheated Resin Composite

  after 36 months

• Assessment of Oral Health Impact Profile

  after 12 months

Study Arms (1)

Patients with PLV

EXPERIMENTAL

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

Interventions

Conventional Resin Cement vs Preheated Resin Composite PROCEDURE

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

Also known as: Variolink Esthetic (Ivoclar Vivadent, Schaan, Liechtenstein), Enamel Plus HFO (Micerium, Avegno, Italy)

Patients with PLV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with active caries lesions or periodontal disease.
• Patients with occlusal disfunction or uncontrolled parafunctional habits.
• Patients unwilling to come back to checkups.

Sponsors & Collaborators

• Universidad Arturo Prat: lead
• Universidad de Concepcion: collaborator

Study Sites (1)

Clínica Áurea Iquique

Iquique, 1101128, Chile

Location

Related Publications (9)

• 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.

  PMID: 22664565 BACKGROUND

• 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.

  PMID: 28960775 BACKGROUND

• 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.

  PMID: 33172798 BACKGROUND

• 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.

  PMID: 30147872 BACKGROUND

• 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.

  PMID: 33721347 BACKGROUND

• 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.

  PMID: 23444201 BACKGROUND

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

  PMID: 22067068 BACKGROUND

• 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.

  PMID: 26568893 BACKGROUND

• 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.

  PMID: 22319761 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Dental Surgery

Model Details: In this study, two different luting resin cements will be used to bond ceramic partial laminate veneers. This is a randomized split mouth clinical trial, in which only maxillary anterior teeth will be treated with partial veneers (maximum 6 teeth, upper incisors and canines. This zone is called sector 2). For this purpose, sector 2 will be divided in two sides (right and left), and randomization will be performed to select a conventional resin cement or a preheated resin composite luting agent as the material of choice for the right or left side of the mouth to bond ceramic partial laminate veneers for every recruited patient. Number of participants is related to the number of restorations.

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: February 2, 2022
• Study Start: April 18, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)