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

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ClinicalTrials.gov Identifier: NCT03713970
Recruitment Status : Not yet recruiting
First Posted : October 22, 2018
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
shafeq hashem saif aqlan, Cairo University

Brief 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.

Condition or disease Intervention/treatment Phase
Fracture Tooth Discoloration Procedure: celtra duo press Procedure: IPS e.max press Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: two groups withe different laminate veneers restorations(celtra duo press and IPS e.max press)
Masking: Double (Participant, Investigator)
Masking Description: After examining the participant for eligibility,each participant will be given a number start from one by Shafeq(the main researcher )i.e. each participant will be assigned by numbers and allocated to different groups using these numbers.(for example, the odd numbers to the intervention and the even numbers to the control group)
Primary Purpose: Treatment
Official Title: Clinical Performance of Ceramic Laminate Veneers Made With Celtra Duo Press and IPS e.Max Press Ceramic. Randomized Controlled Clinical Trial-one Year Evaluation
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : December 1, 2019

Arm Intervention/treatment
Experimental: Celtra duo press
Celtra duo press ingot 20g for three laminate veneers
Procedure: celtra duo press
celtra duo press ingot

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

Active Comparator: IPS e.max press
IPS e.max press ingot 20g for three laminate veneers
Procedure: celtra duo press
celtra duo press ingot

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




Primary Outcome Measures :
  1. patient satisfaction using questionnaire [ Time Frame: 0ne 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



Secondary Outcome Measures :
  1. fracture using questionnaire [ 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

    1. minor cracks line over the restoration
    2. minor chipping of the restoration (1/4)
    3. moderate chipping of the restoration (1/2)
    4. sever chipping of the restoration
    5. complete fracture

  2. shade matching using questionnaire [ Time Frame: one 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.


  3. Marginal adaptation using questionnaire [ 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

    1. enamel exposed
    2. base or dentin exposed
    3. debonding from one end
    4. debonding from both ends

  4. sensitivity using questionnaire [ 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

    1. slight sensitivity
    2. moderate sensitivity
    3. sever sensitivity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713970


Contacts
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Contact: shafeq hashem aqlan, M.D.S 00201148677138 shafeqaqlan@gmail.com
Contact: lamia sayed kheiralla, PHD 00201143110707 lamiask@yahoo.com

Sponsors and Collaborators
Cairo University

Publications of Results:
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Responsible Party: shafeq hashem saif aqlan, director, Cairo University
ClinicalTrials.gov Identifier: NCT03713970     History of Changes
Other Study ID Numbers: CEBD-CU-2018-10-20
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by shafeq hashem saif aqlan, Cairo University:
cetra duo press,e.max press,clinical performance

Additional relevant MeSH terms:
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Tooth Discoloration
Tooth Diseases
Stomatognathic Diseases