Patient Satisfaction of Glazed IPS Empress CAD Versus Glazed Celtra Duo Ceramic Laminate Veneers
Primary Purpose
Tooth Discoloration, Tooth Fractures
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
glazed Celtra Duo
IPS Empress CAD
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Discoloration
Eligibility Criteria
Inclusion Criteria:
All subjects are required to be
- From 18-50 years old, be able to read and sign the informed consent document.
- Physically and psychologically able to tolerate conventional restorative procedures
- have no active periodontal or pulpal diseases, have teeth with good restorations
Patients with teeth problems indicated for laminate veneer:
- Discoloration
- Fracture not involving more than 50% enamel loss
- Mild malposition
- Diastema
- Enamel fluorosis
- Stained or defective restorations
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
glazed Celtra Duo
Glazed IPS Empress CAD
Arm Description
zirconia reinforced lithium silicate glass ceramic is infiltrated with 10% zirconia by weight, producing zirconia reinforced lithium silicate ceramic
glazed Leucite based glass ceramics ,Its a glass ceramic which is etchable and proved to have good esthetics if used for laminate veneers
Outcomes
Primary Outcome Measures
fracture resistance
scores
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03129711
Brief Title
Patient Satisfaction of Glazed IPS Empress CAD Versus Glazed Celtra Duo Ceramic Laminate Veneers
Official Title
Patient Satisfaction and One Year Clinical Evaluation of Glazed IPS Empress CAD Versus Glazed Celtra Duo Ceramic Laminate Veneers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2017 (Anticipated)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Discoloration, Tooth Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
glazed Celtra Duo
Arm Type
Experimental
Arm Description
zirconia reinforced lithium silicate glass ceramic is infiltrated with 10% zirconia by weight, producing zirconia reinforced lithium silicate ceramic
Arm Title
Glazed IPS Empress CAD
Arm Type
Active Comparator
Arm Description
glazed Leucite based glass ceramics ,Its a glass ceramic which is etchable and proved to have good esthetics if used for laminate veneers
Intervention Type
Other
Intervention Name(s)
glazed Celtra Duo
Intervention Description
zirconia reinforced lithium silicate
Intervention Type
Other
Intervention Name(s)
IPS Empress CAD
Other Intervention Name(s)
Leucite based
Intervention Description
Standard etchable glass ceramic for laminate veneers
Primary Outcome Measure Information:
Title
fracture resistance
Description
scores
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All subjects are required to be
From 18-50 years old, be able to read and sign the informed consent document.
Physically and psychologically able to tolerate conventional restorative procedures
have no active periodontal or pulpal diseases, have teeth with good restorations
Patients with teeth problems indicated for laminate veneer:
Discoloration
Fracture not involving more than 50% enamel loss
Mild malposition
Diastema
Enamel fluorosis
Stained or defective restorations
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Omnia Wafik El mesallamy, MDS
Phone
01006595375
Email
omniawafik@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jylan El Guindy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Patient Satisfaction of Glazed IPS Empress CAD Versus Glazed Celtra Duo Ceramic Laminate Veneers
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