Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Patient Satisfaction of Glazed IPS Empress CAD Versus Glazed Celtra Duo Ceramic Laminate Veneers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03129711
Recruitment Status : Unknown
Verified April 2017 by Omnia Mohammed Wafik, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : April 26, 2017
Last Update Posted : May 2, 2017
Sponsor:
Information provided by (Responsible Party):
Omnia Mohammed Wafik, Cairo University

Brief Summary:
The most frequent reason for failure of laminate veneers made of glass ceramics (feldspathic, leucite based and lithium silicate based ceramics) was fracture of the ceramic, Therefore, ceramic materials that have higher fracture resistance, especially for patients suffering from abnormal occlusion, are needed.

Condition or disease Intervention/treatment Phase
Tooth Discoloration Tooth Fractures Other: glazed Celtra Duo Other: IPS Empress CAD Not Applicable

Detailed Description:

IPS Empress CAD is a leucite glass-ceramic of the SiO2-Al2-O3-K2O material systems with leucite crystal ranging from 5 to 10 µm in size. The leucite crystals increase the material strength and interferes with crack propagation, while the fracture energy is absorbed by the crystalline phase. The resistance and flexural strength (160 Mpa) is improved by the difference in the coefficient of thermal expansion between the glass phase and the crystalline phase and the cooling process following sintering phase.

CELTRA DUO: is a new generation of glass ceramic material. With the aid of a new manufacturing process, the glass ceramic is infiltrated with 10% zirconia by weight, producing zirconia reinforced lithium silicate ceramic (ZLS). The material is characterized by a unique homogenous structure with fine grains that provides excellent material quality and consistency, high strength properties and long term performance. In addition, the material offers satisfying processing characteristics which can be milled and polished easily. After milling the restorations are shaded correctly shaded, with no need for crystallization step 10. The milled restorations have a flexural strength of 210 MPa. After stain and glaze firing the restoration will exhibit a flexural strength up to 370 MPa.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Patient Satisfaction and One Year Clinical Evaluation of Glazed IPS Empress CAD Versus Glazed Celtra Duo Ceramic Laminate Veneers
Estimated Study Start Date : August 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Experimental: glazed Celtra Duo
zirconia reinforced lithium silicate glass ceramic is infiltrated with 10% zirconia by weight, producing zirconia reinforced lithium silicate ceramic
Other: glazed Celtra Duo
zirconia reinforced lithium silicate

Active Comparator: Glazed IPS Empress CAD
glazed Leucite based glass ceramics ,Its a glass ceramic which is etchable and proved to have good esthetics if used for laminate veneers
Other: IPS Empress CAD
Standard etchable glass ceramic for laminate veneers
Other Name: Leucite based




Primary Outcome Measures :
  1. fracture resistance [ Time Frame: 1 year ]
    scores



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All subjects are required to be

    1. From 18-50 years old, be able to read and sign the informed consent document.
    2. Physically and psychologically able to tolerate conventional restorative procedures
    3. have no active periodontal or pulpal diseases, have teeth with good restorations
    4. Patients with teeth problems indicated for laminate veneer:

      1. Discoloration
      2. Fracture not involving more than 50% enamel loss
      3. Mild malposition
      4. Diastema
      5. Enamel fluorosis
      6. Stained or defective restorations
    5. Willing to return for follow-up examinations and evaluation

Exclusion Criteria:

  • 1. Patients in the growth stage with partially erupted teeth 2. Patient with fractured teeth of more than 50% enamel loss 3. Patients with poor oral hygiene and motivation 4. Pregnant women's 5. Patient with post and core endodontically treated teeth 6. Psychiatric problems or unrealistic expectations 7. Lack of opposite occluding dentition in the area intended for restoration 8. Patients involved in contact sports 9. Teeth with deep discoloration

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): NCT03129711


Contacts
Layout table for location contacts
Contact: Omnia Wafik El mesallamy, MDS 01006595375 omniawafik@gmail.com
Contact: Jylan El Guindy

Sponsors and Collaborators
Cairo University

Layout table for additonal information
Responsible Party: Omnia Mohammed Wafik, Assistant lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT03129711     History of Changes
Other Study ID Numbers: 1691985
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Tooth Discoloration
Tooth Fractures
Tooth Diseases
Stomatognathic Diseases
Tooth Injuries
Wounds and Injuries