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NCT Number: NCT07113873

Patient Satisfaction and Clinical Performance of Ultra-translucent Multi-layer Monolithic Zirconia and Lithium Disilicate Ceramic Laminate Veneers. Randomized Control Clinical Trial

Despite of the improved esthetics of ultra-translucent zirconia, bonding between resin cement and zirconia is difficult to achieve because of their chemical inertness and lack of silica content. However, the effect of the bond strength with the new generation of high-translucent zirconia materials is not clear and further studies are needed. Kongkiatkamon, Suchada et al., (2023) The long-term bond strength of cubic zirconia was similar to 3Y-TZP zirconia and lithium disilicate ceramics and showed sufficient bond strength. A 5-mol% yttria-stabilized tetragonal Zr polycrystal showed high shear bond strength similar to Li disilicate glass-ceramic. Air blasting of Zr followed by primers and resin cements based on 10-MDP monomer has proven its efficiency in Zr-resin bonding. Both ultra-translucent 5Y-PSZ Zr and Li disilicate offer viable options for esthetic restorations on anterior teeth Adak et al. (2023),Elsisi et al. (2024) Currently, there is a lack of reports in the literature regarding the long-term clinical performance of ultra-translucent zirconia, especially considering its use in manufacturing monolithic veneers. Therefore, the purpose of the present clinical trial is to assess the validity of using ultra-translucent multi-layer zirconia ceramic veneer as an alternative to lithium disilicate ceramic veneer

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Preservation of tooth structure and prevention of needless tooth structure removal are basic and important principles in prosthodontics. Striving to achieve the cosmetic aspect is also a basic requirement, especially in the modern world Fawakhiri et al. (2023) Porcelain laminate veneers are one of the most popular cosmetic and minimally invasive dental treatments. These veneers can change the color, contour, shape, and size of the teeth they cover and bond to tooth structure with the use of adhesive cements. A thin layer of enamel (0.5-.8 mm) is removed to provide space for each veneer Piemjai and Donpinprai (2023) Several ceramic materials are currently indicated for veneers: lithium disilicate, feldspathic ceramic, feldspathic reinforced with leucite, fluorapatite, and lithium silicate reinforced with zirconia. All of these ceramics exhibit high translucency characteristics due to the high content of glassy matrix in their composition, thus providing highly satisfactory esthetics in addition to excellent adhesion to resin cement through the conditioning with hydrofluoric acid (4%-10%) followed by silanization Souza et al. (2017) Lithium disilicate ceramics belong to the silica-based ceramics family. They are commonly used for the fabrication of laminate veneers owing to their excellent optical properties, including their superior translucency and strong bonding to the tooth enamel surface when etched with hydrofluoric acid and then silanized Ojeda et al. (2023) Longevity is one of the most important factors to predict the survival and success of restorations. Many longitudinal clinical studies have evaluated the performance of ceramic veneer restorations and have confirmed good clinical performance, excellent aesthetics, and a high level of patient satisfaction. Major clinical complications commonly resulting in the failure of ceramic veneer restorations are fracture and debonding (Monaraks, 2018) The long-term clinical success of ceramic-based restorations is strongly dependent on their retention to teeth or abutment substrates by using adhesive systems and resin-matrix cements in vitro research has shown that load-to-fracture values of monolithic zirconia are higher than those of LS2; the latter, in turn, are higher than those of ZLS Zarone et al. (2019) ,(Souza et al., 2023) 6 The excellent biocompatibility and superior mechanical properties of zirconium dioxide (zirconia) ceramics make them a material of choice in prosthetic dentistry. Nevertheless, zirconia ceramics have not been used for the fabrication of laminate veneers because the opaqueness and low translucency of zirconia ceramics yield undesirable esthetic results. Due to the absence of any glassy matrix, zirconia is free from silica and, consequently, cannot be conditioned with conventional acid etching techniques, differently from glass-ceramics. Kusaba, Kosuke et al., (2018) , Zarone et al. (2019) Lately, the ultra-translucent multilayered zirconia has been introduced to the market. This material structured to replicate the naturality of teeth according to each anatomical region, keeping translucency at the incisal edge and a higher opacity at the cervical area. The multilayer blanks are pre-layered and thus contain different shades. There is scientific evidence reporting that the darker the color the higher the degree of opacity, that's to say the lower the translucency becomes. The color of the blanks is increasingly lighter and thus more translucent towards the incisal area. The dental technician can use CAD software to help to determine color sequences and intensities by positioning the constructed restoration in the blank. One advantage resulting from the combination of highly esthetic (color and translucency values are similar to those of natural teeth) and highly stable materials is better treatment with restorations with low space requirements. This Ultra-translucent Zirconia ceramic veneers have a minimum thickness of 0.1-0.3 mm, a more conservative option than glass-ceramic restorations Alqutaibi et al. (2022), Gomes et al., (2022), ("Three Generations of Zirconia: From Veneered to Monolithic. Part I.," 2017)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1- Age between 18 and 50 years. 2. Absence of abnormal functional habits such as bruxism. 3. Good condition of gingival and periodontal tissues. 4. Good oral health. 5. A clear indication for patients for treatment with ceramic laminate veneers: Presence of diastema, moderate discolored dental restorations, slight modification of color in the discolored teeth, and modification of shape and sizes of the teeth.

  • Patient commitment for attending follow up session

Exclusion criteria

  • Age under 18 years
  • Bad oral hygiene
  • Dysfunctional habits and bruxism
  • Periodontal diseases
  • High risk of caries
  • Inadequate enamel for bonding
  • Extreme staining and color change in tooth -

Treatment and study plan

ultra-translucent monolithic multi layered zirconia

Other

laminate veneer

lithium disilcate ceramics

Other

laminate veneer

Primary outcomes

  1. Patient Satisfaction

    Time frame: 24 month

    Numerical (discrete) ("0" unsatisfied - "10" satisfied)

Secondary outcomes

  1. Color Stability

    Time frame: 24 month

    ΔE<2.7

  2. Marginal Integrity

    Time frame: 24 month

    Alpha (A) No visible evidences of crevice along the margins; no catch or penetration of the explorer.

    • Bravo (B) Visible evidence of crevice and/or catch of explorer; no penetration of the explorer.
    • Charlie (C) Visible evidence of crevice and penetration of the explorer
  3. Gingival Health

    Time frame: 24 month

    • Alpha (A) Normal gingiva
    • Bravo (B) Mild inflammation - slight change in color and slight edema but no bleeding on probing 11 13-Participant timeline

    The patient will be treated in a regular sequence:

    visit 1: proper examination for the participants (clinically and radiographically) and alginate impressions for diagnosis on primary casts and for mounting Visit 2: Preparation for abutment teeth, final impression using elastic impression material and provisional restoration.

    Visit 3: permanent cementation of the final restoration Visit 4: follow-up every 3month for 24 months 14-Calculated sample size: Sample size calculated depending on a previous study by Verniani et al. (2024) as reference. According to this study, the minimally accepted sample size was 7 per group, when mean ± standard deviation of patient satisfaction at baseline in-group I was 7.1±1.5 while after 2 years was 9.5 ±2, with 1.33 effect size, when the power was 80 % & type I error probability was 0.05. Total sample si

  4. Retention

    Time frame: 24 month

    • Alpha (A)No loss of restorative material
    • Bravo (B) Partial loss of restorative material
    • Charlie (C) Missing restoration

Study contacts

Contact information is provided by the study sponsor or research team.

Gihan El naggar Professor, PhD

CONTACT

[email protected]

01117676668

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical Performance of Ultra-translucent Multi-layer Monolithic Zirconia and Lithium Disilicate Ceramic Laminate Veneers

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 11, 2025
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.