Clinical Evaluation of the Fracture Resistance for E-max Cad and Vita Suprinity Laminate Veneers
Primary Purpose
Tooth Discoloration
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vita suprinity
Emax 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 18-60 years old, and 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 (e.g. discoloration, fracture not involve more than 50% enamel loss, mild malposition, ….)
- Willing to return for follow-up examinations and evaluation
Exclusion Criteria:
- Patients in the growth stage with partially erupted teeth
- Patient with fractured teeth of more than 50% enamel loss
- Patients with poor oral hygiene and motivation
- Pregnant women
- Psychiatric problems or unrealistic expectations
- Lack of opposite occluding dentition in the area intended for restoration
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vita suprinity
Emax cad
Arm Description
Vita Suprinity is a recent material with glass ceramic enriched with zirconia (approx. 10 % by weight) that offer practices and laboratories a high-strength, zirconia-reinforced lithium silicate ceramic (ZLS).
lithium disilicate glass-ceramic which is etchable and proved to have good success rate if used for laminate venners
Outcomes
Primary Outcome Measures
Fracture resistance assessed by clinical evaluation using dental mirror and probe according to the modified united states public health criteria
clinical evaluation of Fracture resistance
Secondary Outcome Measures
Patient satisfaction assessed using a Questionnaire
Questionnaire for patient satisfaction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02940717
Brief Title
Clinical Evaluation of the Fracture Resistance for E-max Cad and Vita Suprinity Laminate Veneers
Official Title
Clinical Evaluation of the Fracture Resistance for E-max Cad and Vita Suprinity Laminate Veneers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients need laminate veneer for their teeth usually use Emax CAD as an etchable ceramic. Yet fracture may occur so a stronger material is needed. Vita Suprinity is a recent material with glass ceramic enriched with zirconia (approx. 10% by weight) that offer practices and laboratories a high-strength, zirconia-reinforced lithium silicate ceramic (ZLS) and can be used to fabricate laminate veneers but the investigators have to know clinically it is fracture resistance, so the investigators are going to have Parallel groups in a randomized clinical trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Discoloration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vita suprinity
Arm Type
Experimental
Arm Description
Vita Suprinity is a recent material with glass ceramic enriched with zirconia (approx. 10 % by weight) that offer practices and laboratories a high-strength, zirconia-reinforced lithium silicate ceramic (ZLS).
Arm Title
Emax cad
Arm Type
Active Comparator
Arm Description
lithium disilicate glass-ceramic which is etchable and proved to have good success rate if used for laminate venners
Intervention Type
Other
Intervention Name(s)
Vita suprinity
Other Intervention Name(s)
zirconia-reinforced lithium silicate ceramic
Intervention Description
New glass ceramic material
Intervention Type
Other
Intervention Name(s)
Emax CAD
Other Intervention Name(s)
lithium disilicate glass ceramic
Intervention Description
standard etchable glass ceramic used for laminate venneers
Primary Outcome Measure Information:
Title
Fracture resistance assessed by clinical evaluation using dental mirror and probe according to the modified united states public health criteria
Description
clinical evaluation of Fracture resistance
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Patient satisfaction assessed using a Questionnaire
Description
Questionnaire for patient satisfaction
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 18-60 years old, and 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 (e.g. discoloration, fracture not involve more than 50% enamel loss, mild malposition, ….)
Willing to return for follow-up examinations and evaluation
Exclusion Criteria:
Patients in the growth stage with partially erupted teeth
Patient with fractured teeth of more than 50% enamel loss
Patients with poor oral hygiene and motivation
Pregnant women
Psychiatric problems or unrealistic expectations
Lack of opposite occluding dentition in the area intended for restoration
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27087687
Citation
Elsaka SE, Elnaghy AM. Mechanical properties of zirconia reinforced lithium silicate glass-ceramic. Dent Mater. 2016 Jul;32(7):908-14. doi: 10.1016/j.dental.2016.03.013. Epub 2016 Apr 14.
Results Reference
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PubMed Identifier
22821429
Citation
Gresnigt MM, Kalk W, Ozcan M. Clinical longevity of ceramic laminate veneers bonded to teeth with and without existing composite restorations up to 40 months. Clin Oral Investig. 2013 Apr;17(3):823-32. doi: 10.1007/s00784-012-0790-5. Epub 2012 Jul 21.
Results Reference
background
PubMed Identifier
27004277
Citation
Weyhrauch M, Igiel C, Scheller H, Weibrich G, Lehmann KM. Fracture Strength of Monolithic All-Ceramic Crowns on Titanium Implant Abutments. Int J Oral Maxillofac Implants. 2016 Mar-Apr;31(2):304-9. doi: 10.11607/jomi.4601.
Results Reference
background
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Clinical Evaluation of the Fracture Resistance for E-max Cad and Vita Suprinity Laminate Veneers
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