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Completed

NCT Number: NCT03713970

Clinical Performance of Ceramic Laminate Veneers Made With Celtra Duo Press and IPS e.Max Press Ceramic

The aim of the present study is to assess the clinical performance (patient satisfaction, fracture, shade matching, Marginal adaptation and sensitivity) of laminate veneers made with celtra duo press ceramic and IPS e.max press ceramic with incisal wrap design.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

department of fixed prosthodontic-Cairo university

Cairo, 02, Egypt

About this study

Ceramic materials are widely used for esthetic restorations because of their physical and optical properties that enhance patient satisfaction to dental restorations. several ceramic materials are currently available, including the lithium-reinforced glass ceramic like e.max press, which stands out for its excellent esthetic appearance and mechanical properties.also ZLS (zirconia-reinforced lithium silicate) are a function of its unique micro structure (500-700 nm in size, correspond exactly to the wavelength range of natural daylight). The presence of 10% zirconia in the glass phase in atomically dissolved form provides high strength and ensures safe and long-lasting restorations .The result is a large number of very fine-grained lithium silicate crystals, whose high glass content give the material its excellent light-optical and mechanical properties.

Translucency, opalescence, fluorescence and the chameleon effect all benefit, with high edge stability and excellent polishability being an added plus.3 Despite the recent introduction of improved ceramic materials, patient satisfaction with restoration contour,symmetry,margins and shade matching natural teeth with ceramic restorations is still one of the major challenges in clinical practice. The determination and interpretation of natural tooth color involve the selection and reproduction of ceramic shade and choice of restorative material. These factors have had a major influence on the final color of restorative treatments. Color-measuring instruments assist in shade analysis, thus minimizing the subjective variables of this process. Color readings allow improved determination of the restoration shade and better communication with the dental laboratory.4The influences of underlying substrate,8-9 luting agent,ceramic thickness and translucency, and restoration type14 on the color variation of ceramic restorations have been investigated in in vitro studies. Thus, the purpose of this study was to evaluate clinical performance of celtra duo press ceramic and IPS e.max press ceramic laminate veneers including patient satisfaction, fracture, shad matching, marginal adaptation and sensitivity.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • All subjects were required to be
  • at least 18 years old
  • able to read and sign the informed consent document
  • physically and psychologically able to tolerate conventional restorative procedures
  • no active periodontal or pulpal diseases and teeth with good restorations
  • teeth problems indicated for laminate veneer (e.g. discoloration, enamel fracture, chipping and mild malposition….)
  • willing to return for follow-up examinations and evaluation
  • Existing composite restorations of good quality, presenting no caries, ditching, or marginal staining were not removed prior to tooth preparation.
  • normal bite (class I Kennedy classification)

Exclusion criteria

  • Patients in the growth stage with partially erupted teeth
  • fractured teeth of more than 50% enamel loss
  • poor oral hygiene and motivation
  • Pregnant women's
  • endodontically treated teeth
  • Psychiatric problems

Treatment and study plan

celtra duo press

Procedure

celtra duo press ingot

IPS e.max press

Procedure

IPS e.max press ingot

Primary outcomes

  1. color matching

    Time frame: 0ne year

    shad matching of both laminate veneers made with two materials compared to normal teeth will be evaluated using modified united state public health service criteria (USPHS) 0 Excellent colour match and shade between restoration and adjacent tooth, almost invisible.

    1 Slightly mismatching between the restoration and the adjacent tooth, which is in the normal range of tooth colour, translucence and/or shade.

    3 Obvious mismatch, beyond the normal range. 4 Gross mismatch/aesthetically displeasing colour, shade and/or translucence.

Secondary outcomes

  1. fracture

    Time frame: one year

    fracture of dental laminate veneers made with two materials will be evaluated using modified united state public health service criteria (USPHS) 0 no fracture

    • minor cracks line over the restoration
    • minor chipping of the restoration (1/4)
    • moderate chipping of the restoration (1/2)
    • sever chipping of the restoration
    • complete fracture
  2. patient satisfaction

    Time frame: one year

    Primary objective to assess clinical performance (patient satisfaction) of laminate veneers made with celtra duo press ceramic and IPS e.max press ceramic with incisal wrap design using questionnaire.

    Questions

    Are you satisfied with new laminate? Are you satisfied with your laminate color? Have you noticed any color change in your crown till now? Do you feel that your laminate looks natural? Have you suffered from any kind of pain or problem during laminate use? Do you like your laminate alignment? Do you like your general appearance? Do you feel that the laminate is in harmony with the adjacent teeth? Have you experienced gingival or periodontal inflammation around the laminate after its insertion? Has the laminate stability affected through this year?

    the participant should be answer yes or no

  3. Marginal adaptation

    Time frame: one year

    Marginal adaptation of both laminate veneers made with two materials will be evaluated using modified united state public health service criteria (USPHS) 0= smooth margin

    • enamel exposed
    • base or dentin exposed
    • debonding from one end
    • debonding from both ends
  4. sensitivity

    Time frame: one year

    sensitivity of teeth that restored with laminate veneers made with two materials will be evaluated using modified united state public health service criteria (USPHS) 0 no sensitivity

    • slight sensitivity
    • moderate sensitivity
    • sever sensitivity

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical Performance of Ceramic Laminate Veneers Made With Celtra Press and IPS e.Max Press Ceramic. Randomized Controlled Clinical Trial-one Year Evaluation

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 22, 2018
Registry last updated
Feb 12, 2024

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.

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