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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03713970
Other study ID # CEBD-CU-2018-10-20
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 25, 2021
Est. completion date August 1, 2022

Study information

Verified date February 2024
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date August 1, 2022
Est. primary completion date July 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
celtra duo press
celtra duo press ingot
IPS e.max press
IPS e.max press ingot

Locations

Country Name City State
Egypt department of fixed prosthodontic-Cairo university Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Alhekeir DF, Al-Sarhan RA, Al Mashaan AF. Porcelain laminate veneers: Clinical survey for evaluation of failure. Saudi Dent J. 2014 Apr;26(2):63-7. doi: 10.1016/j.sdentj.2014.02.003. Epub 2014 Mar 26. — View Citation

Chu SJ, Trushkowsky RD, Paravina RD. Dental color matching instruments and systems. Review of clinical and research aspects. J Dent. 2010;38 Suppl 2:e2-16. doi: 10.1016/j.jdent.2010.07.001. Epub 2010 Aug 1. — View Citation

Stevenson B, Ibbetson R. The effect of the substructure on the colour of samples/restorations veneered with ceramic: a literature review. J Dent. 2010 May;38(5):361-8. doi: 10.1016/j.jdent.2010.01.009. Epub 2010 Feb 1. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary color matching 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.
0ne year
Secondary fracture 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
one year
Secondary patient satisfaction 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
one year
Secondary Marginal adaptation 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
one year
Secondary sensitivity 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
one year
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