Back to resultsOne Year Clinical Evaluation of IPS Empress CAD Versus Polished Celtra Duo Ceramic Laminate Veneers
Primary Purpose
Tooth Discoloration, Tooth Fractures, Diastema
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
IPS Empress CAD
polished Celtra Duo
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.
- Have no active periodontal or pulpal diseases, have teeth with good restorations
- Psychologically and physically able to tolerate conventional dental procedures
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
- Able to return for follow-up examinations and evaluation
Exclusion Criteria:
- Patient with post and core endodontically treated teeth
- Patient with fractured teeth of more than 50% enamel loss
- Patients with poor oral hygiene and motivation
- Pregnant women's
- Patients in the growth stage with partially erupted teeth
- Psychiatric problems or unrealistic expectations
- Lack of opposing dentition in the area of interest
- Patients involved in contact sports
- Teeth with deep discoloration
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
IPS Empress CAD
polished Celtra Duo
Arm Description
Leucite Based glass Ceramics which is etchable ceramics and proved to have good success rate if used for laminate veneers
Zirconia reinforced lithium silicate, it is a recent material with glass ceramics enriched with 10% zirconia that offers high strength properties
Outcomes
Primary Outcome Measures
Fracture
number of fractured laminates
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03136276
Brief Title
One Year Clinical Evaluation of IPS Empress CAD Versus Polished Celtra Duo Ceramic Laminate Veneers
Official Title
One Year Clinical Evaluation of IPS Empress CAD Versus Polished Celtra Duo Ceramic Laminate Veneers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2017 (Anticipated)
Primary Completion Date
July 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
Data Monitoring Committee
No
5. Study Description
Brief Summary
When restoring teeth with IPS Empress laminate veneers, fracture of restorations may occur. So, material with higher mechanical properties is required. Celtra Duo is a new material with glass ceramics infiltrated by 10% zirconia particles which increase the fracture resistance of the material.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Discoloration, Tooth Fractures, Diastema
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
double blind
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IPS Empress CAD
Arm Type
Active Comparator
Arm Description
Leucite Based glass Ceramics which is etchable ceramics and proved to have good success rate if used for laminate veneers
Arm Title
polished Celtra Duo
Arm Type
Experimental
Arm Description
Zirconia reinforced lithium silicate, it is a recent material with glass ceramics enriched with 10% zirconia that offers high strength properties
Intervention Type
Other
Intervention Name(s)
IPS Empress CAD
Other Intervention Name(s)
leucite based glass ceramics
Intervention Description
standard etchable glass ceramics
Intervention Type
Other
Intervention Name(s)
polished Celtra Duo
Other Intervention Name(s)
zirconia reinforced lithium silicate (ZLS)
Intervention Description
new glass ceramic material
Primary Outcome Measure Information:
Title
Fracture
Description
number of fractured laminates
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 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.
Have no active periodontal or pulpal diseases, have teeth with good restorations
Psychologically and physically able to tolerate conventional dental procedures
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
Able to return for follow-up examinations and evaluation
Exclusion Criteria:
Patient with post and core endodontically treated teeth
Patient with fractured teeth of more than 50% enamel loss
Patients with poor oral hygiene and motivation
Pregnant women's
Patients in the growth stage with partially erupted teeth
Psychiatric problems or unrealistic expectations
Lack of opposing dentition in the area of interest
Patients involved in contact sports
Teeth with deep discoloration
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hayat El-Banna, M.D.s
Phone
01001248734
Email
hayat.elbanna@dentistry.cu.edu.eg
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
One Year Clinical Evaluation of IPS Empress CAD Versus Polished Celtra Duo Ceramic Laminate Veneers
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