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Trial record 93 of 119 for:    ZIRCONIUM

Clinical Evaluation and Patient Satisfaction of Shade Matching Between Natural Teeth and Monolithic All-ceramic Crowns Fabricated From Two Materials

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ClinicalTrials.gov Identifier: NCT03779607
Recruitment Status : Not yet recruiting
First Posted : December 18, 2018
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Mohamed el sayed bekhiet, Cairo University

Brief Summary:
evaluation of color difference between zirconia reinforced lithium silicate (celtra press) VS lithium disilicate (Emax) in relation to natural tooth structure to determine which monolithic material will provide restoration with exact shade and optical properties as natural tooth structure.

Condition or disease Intervention/treatment Phase
Natural Optical Properties Other: Celtra Press Not Applicable

Detailed Description:

eligible patients will be randomized in 2 equal group between study group (celtra press) and control group (Emax) .

Single tooth in esthetic zone requiring full coverage crown is prepared to receive an all ceramic crown of .

Grouping: The crowns will be divided into two groups:

I:Teeth receiving crowns fabricated from IPS emax press ( ivoclarvivadent) II:Teeth receiving crowns fabricatedfrom Celtrapress(dentsplysirona).

Shade will be measured using intraoral spectrophotometer and evaluated.

The color difference (ΔE ) will be calculated for each sample using the following equation: ΔE =[(ΔL*)²+(Δa*)² + (Δb*)²]½

ΔE (perceptibility threshold ) will be evaluated for each group.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Evaluation and Patient Satisfaction Ofshade Matching Between Natural Teeth and Monolithic All-ceramic Crowns Fabricated From Two Materials (Randomized Controlled Clinical Trial)
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: IPS e.max Press(lithium di silicate)
Lithium disilicate reinforced glass ceramics are available in the market in two forms according to the technique of manufacturing, either heat pressed ingots or CAD/CAM blocks for milling. The heat pressed lithium disilicate glass ceramic consists of approximately 70% lithium disilicatecrystals(the main crystal phase) having a needle like shape that are embedded in a glassy matrix. The crystals length is about 3 to 6 μm. The heat pressed ingots are fully crystallized and the restoration is fabricated by the lost wax technique where the lithium disilicate ingots are pressed into the investment mold at high temperature. The pressed lithium disilicate has strong flexural strength values(range 400 ± 40 MPa)
Other: Celtra Press

new class of zirconia-reinforced lithium silicate material available to labs for pressing. This unique material provides top aesthetics and is virtually impossible to tell apart from a natural tooth.

Celtra Press is a multiphase ceramic consisting of a glass matrix and lithium disilicate crystals having a crystal length of about 1.5 µm plus nano-scale lithium phosphate . In addition to Li2O and SiO2, Celtra Press contains about 10% zirconia (ZrO2), which is dissolved completely in the glass phase rather than in crystalline form. Celtra Press is characterized by a high strength of about 500 MPa and excellent flow properties during pressing.


Experimental: Celtra Press

new class of zirconia-reinforced lithium silicate material available to labs for pressing. This unique material provides top aesthetics and is virtually impossible to tell apart from a natural tooth.

Celtra Press is a multiphase ceramic consisting of a glass matrix and lithium disilicate crystals having a crystal length of about 1.5 µm plus nano-scale lithium phosphate . In addition to Li2O and SiO2, Celtra Press contains about 10% zirconia (ZrO2), which is dissolved completely in the glass phase rather than in crystalline form. Celtra Press is characterized by a high strength of about 500 MPa and excellent flow properties during pressing.

Other: Celtra Press

new class of zirconia-reinforced lithium silicate material available to labs for pressing. This unique material provides top aesthetics and is virtually impossible to tell apart from a natural tooth.

Celtra Press is a multiphase ceramic consisting of a glass matrix and lithium disilicate crystals having a crystal length of about 1.5 µm plus nano-scale lithium phosphate . In addition to Li2O and SiO2, Celtra Press contains about 10% zirconia (ZrO2), which is dissolved completely in the glass phase rather than in crystalline form. Celtra Press is characterized by a high strength of about 500 MPa and excellent flow properties during pressing.





Primary Outcome Measures :
  1. Color match [ Time Frame: immediately after crown cementation ]
    using USPHS scoring system


Secondary Outcome Measures :
  1. Patient satisfaction [ Time Frame: immediately after crown cementation ]
    Patient satisfaction using Visual Analogue scale- Binary (Satisfied or not satisfied)



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Age range of the patients from 20-45 years old; able to read and sign the informed consent document, illiterate patient will be avoided.

    2. Patients able physically and psychologically to tolerate conventional restorative procedures.

    3. Patients with no active periodontal or pulpal diseases, having teeth with good restorations.

    4. Patients with teeth problems indicated for full coverage restoration ( coronal fracture where partial coverage would lack retention, malposed or malformed teeth).

    5. Patients with root canal treated teeth requiring full coverage restorations with contralatral tooth not filled orfractured.

    6. Patients willing to return for follow-up examinations and evaluation.

Exclusion Criteria:

  1. Patients in the growth stage with partially erupted teeth.
  2. Patients with poor oral hygiene and motivation.
  3. Pregnant women's to avoid any complication that may occur in dental office due to pregnancy or due to injected anesthetic solution.
  4. Patients with psychiatric problems or unrealistic expectation
  5. Patients have no opposite occluding dentition in the area intended for restoration\
  6. Patients suffer from parafunctional habits.
  7. deep discoloration of abutment .
  8. Smokers and heavy caffeine consumers.

    -


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): NCT03779607


Contacts
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Contact: mohamed bekhiet, master degree student 01224238808 mohamed.bekhet@dentistry.cu.edu.eg

Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Mohamed zamzam, professor Fixed Prosthodontics Faculty of Oral and dental medicine Cairo University
Study Director: Maha Taymour, Associate professor Fixed Prosthodontics Faculty of Oral and dental medicine Cairo University

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Responsible Party: Mohamed el sayed bekhiet, Resident - Fixed prosthodontic department- Faculty of oral and dental medicine, Cairo University
ClinicalTrials.gov Identifier: NCT03779607     History of Changes
Other Study ID Numbers: CEBD-CU-2018-11-13
First Posted: December 18, 2018    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Lithium Carbonate
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs