Clinical Performance of Ceramic Laminate Veneers Made With Celtra Duo Press and IPS e.Max Press Ceramic
Primary Purpose
Fracture, Tooth Discoloration
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
celtra duo press
IPS e.max press
Sponsored by
About this trial
This is an interventional treatment trial for Fracture focused on measuring cetra duo press,e.max press,clinical performance
Eligibility Criteria
Inclusion Criteria:
- All subjects were required to be
- at least 18 years old
- able to read and sign the informed consent document
- physically and psychologically able to tolerate conventional restorative procedures
- no active periodontal or pulpal diseases and teeth with good restorations
- teeth problems indicated for laminate veneer (e.g. discoloration, enamel fracture, chipping and mild malposition….)
- willing to return for follow-up examinations and evaluation
- Existing composite restorations of good quality, presenting no caries, ditching, or marginal staining were not removed prior to tooth preparation.
- normal bite (class I Kennedy classification)
Exclusion Criteria:
- Patients in the growth stage with partially erupted teeth
- fractured teeth of more than 50% enamel loss
- poor oral hygiene and motivation
- Pregnant women's
- endodontically treated teeth
- Psychiatric problems
Sites / Locations
- department of fixed prosthodontic-Cairo universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Celtra duo press
IPS e.max press
Arm Description
Celtra duo press ingot 20g for three laminate veneers
IPS e.max press ingot 20g for three laminate veneers
Outcomes
Primary Outcome Measures
color matching
shad matching of both laminate veneers made with two materials compared to normal teeth will be evaluated using modified united state public health service criteria (USPHS) 0 Excellent colour match and shade between restoration and adjacent tooth, almost invisible.
1 Slightly mismatching between the restoration and the adjacent tooth, which is in the normal range of tooth colour, translucence and/or shade.
3 Obvious mismatch, beyond the normal range. 4 Gross mismatch/aesthetically displeasing colour, shade and/or translucence.
Secondary Outcome Measures
fracture
fracture of dental laminate veneers made with two materials will be evaluated using modified united state public health service criteria (USPHS) 0 no fracture
minor cracks line over the restoration
minor chipping of the restoration (1/4)
moderate chipping of the restoration (1/2)
sever chipping of the restoration
complete fracture
patient satisfaction
Primary objective to assess clinical performance (patient satisfaction) of laminate veneers made with celtra duo press ceramic and IPS e.max press ceramic with incisal wrap design using questionnaire.
Questions
Are you satisfied with new laminate? Are you satisfied with your laminate color? Have you noticed any color change in your crown till now? Do you feel that your laminate looks natural? Have you suffered from any kind of pain or problem during laminate use? Do you like your laminate alignment? Do you like your general appearance? Do you feel that the laminate is in harmony with the adjacent teeth? Have you experienced gingival or periodontal inflammation around the laminate after its insertion? Has the laminate stability affected through this year?
the participant should be answer yes or no
Marginal adaptation
Marginal adaptation of both laminate veneers made with two materials will be evaluated using modified united state public health service criteria (USPHS) 0= smooth margin
enamel exposed
base or dentin exposed
debonding from one end
debonding from both ends
sensitivity
sensitivity of teeth that restored with laminate veneers made with two materials will be evaluated using modified united state public health service criteria (USPHS) 0 no sensitivity
slight sensitivity
moderate sensitivity
sever sensitivity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03713970
Brief Title
Clinical Performance of Ceramic Laminate Veneers Made With Celtra Duo Press and IPS e.Max Press Ceramic
Official Title
Clinical Performance of Ceramic Laminate Veneers Made With Celtra Duo Press and IPS e.Max Press Ceramic. Randomized Controlled Clinical Trial-one Year Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 25, 2021 (Anticipated)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
August 1, 2022 (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 aim of the present study is to assess the clinical performance (patient satisfaction, fracture, shade matching, Marginal adaptation and sensitivity) of laminate veneers made with celtra duo press ceramic and IPS e.max press ceramic with incisal wrap design.
Detailed Description
Ceramic materials are widely used for esthetic restorations because of their physical and optical properties that enhance patient satisfaction to dental restorations. several ceramic materials are currently available, including the lithium-reinforced glass ceramic like e.max press, which stands out for its excellent esthetic appearance and mechanical properties.also ZLS (zirconia-reinforced lithium silicate) are a function of its unique micro structure (500-700 nm in size, correspond exactly to the wavelength range of natural daylight). The presence of 10% zirconia in the glass phase in atomically dissolved form provides high strength and ensures safe and long-lasting restorations .The result is a large number of very fine-grained lithium silicate crystals, whose high glass content give the material its excellent light-optical and mechanical properties.
Translucency, opalescence, fluorescence and the chameleon effect all benefit, with high edge stability and excellent polishability being an added plus.3 Despite the recent introduction of improved ceramic materials, patient satisfaction with restoration contour,symmetry,margins and shade matching natural teeth with ceramic restorations is still one of the major challenges in clinical practice. The determination and interpretation of natural tooth color involve the selection and reproduction of ceramic shade and choice of restorative material. These factors have had a major influence on the final color of restorative treatments. Color-measuring instruments assist in shade analysis, thus minimizing the subjective variables of this process. Color readings allow improved determination of the restoration shade and better communication with the dental laboratory.4The influences of underlying substrate,8-9 luting agent,ceramic thickness and translucency, and restoration type14 on the color variation of ceramic restorations have been investigated in in vitro studies. Thus, the purpose of this study was to evaluate clinical performance of celtra duo press ceramic and IPS e.max press ceramic laminate veneers including patient satisfaction, fracture, shad matching, marginal adaptation and sensitivity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture, Tooth Discoloration
Keywords
cetra duo press,e.max press,clinical performance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two groups withe different laminate veneers restorations(celtra duo press and IPS e.max press)
Masking
ParticipantInvestigator
Masking Description
After examining the participant for eligibility,each participant will be given a number start from one by Shafeq(the main researcher )i.e. each participant will be assigned by numbers and allocated to different groups using these numbers.(for example, the odd numbers to the intervention and the even numbers to the control group)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Celtra duo press
Arm Type
Experimental
Arm Description
Celtra duo press ingot 20g for three laminate veneers
Arm Title
IPS e.max press
Arm Type
Active Comparator
Arm Description
IPS e.max press ingot 20g for three laminate veneers
Intervention Type
Procedure
Intervention Name(s)
celtra duo press
Intervention Description
celtra duo press ingot
Intervention Type
Procedure
Intervention Name(s)
IPS e.max press
Intervention Description
IPS e.max press ingot
Primary Outcome Measure Information:
Title
color matching
Description
shad matching of both laminate veneers made with two materials compared to normal teeth will be evaluated using modified united state public health service criteria (USPHS) 0 Excellent colour match and shade between restoration and adjacent tooth, almost invisible.
1 Slightly mismatching between the restoration and the adjacent tooth, which is in the normal range of tooth colour, translucence and/or shade.
3 Obvious mismatch, beyond the normal range. 4 Gross mismatch/aesthetically displeasing colour, shade and/or translucence.
Time Frame
0ne year
Secondary Outcome Measure Information:
Title
fracture
Description
fracture of dental laminate veneers made with two materials will be evaluated using modified united state public health service criteria (USPHS) 0 no fracture
minor cracks line over the restoration
minor chipping of the restoration (1/4)
moderate chipping of the restoration (1/2)
sever chipping of the restoration
complete fracture
Time Frame
one year
Title
patient satisfaction
Description
Primary objective to assess clinical performance (patient satisfaction) of laminate veneers made with celtra duo press ceramic and IPS e.max press ceramic with incisal wrap design using questionnaire.
Questions
Are you satisfied with new laminate? Are you satisfied with your laminate color? Have you noticed any color change in your crown till now? Do you feel that your laminate looks natural? Have you suffered from any kind of pain or problem during laminate use? Do you like your laminate alignment? Do you like your general appearance? Do you feel that the laminate is in harmony with the adjacent teeth? Have you experienced gingival or periodontal inflammation around the laminate after its insertion? Has the laminate stability affected through this year?
the participant should be answer yes or no
Time Frame
one year
Title
Marginal adaptation
Description
Marginal adaptation of both laminate veneers made with two materials will be evaluated using modified united state public health service criteria (USPHS) 0= smooth margin
enamel exposed
base or dentin exposed
debonding from one end
debonding from both ends
Time Frame
one year
Title
sensitivity
Description
sensitivity of teeth that restored with laminate veneers made with two materials will be evaluated using modified united state public health service criteria (USPHS) 0 no sensitivity
slight sensitivity
moderate sensitivity
sever sensitivity
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All subjects were required to be
at least 18 years old
able to read and sign the informed consent document
physically and psychologically able to tolerate conventional restorative procedures
no active periodontal or pulpal diseases and teeth with good restorations
teeth problems indicated for laminate veneer (e.g. discoloration, enamel fracture, chipping and mild malposition….)
willing to return for follow-up examinations and evaluation
Existing composite restorations of good quality, presenting no caries, ditching, or marginal staining were not removed prior to tooth preparation.
normal bite (class I Kennedy classification)
Exclusion Criteria:
Patients in the growth stage with partially erupted teeth
fractured teeth of more than 50% enamel loss
poor oral hygiene and motivation
Pregnant women's
endodontically treated teeth
Psychiatric problems
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
shafeq hashem aqlan, M.D.S
Phone
00201148677138
Email
shafeqaqlan@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
lamia sayed kheiralla, PHD
Phone
00201143110707
Email
lamiask@yahoo.com
Facility Information:
Facility Name
department of fixed prosthodontic-Cairo university
City
Cairo
ZIP/Postal Code
02
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
dina ahmed moqbil, phd
Phone
01148677132
First Name & Middle Initial & Last Name & Degree
amged aqlan, phd
Phone
01143647134
12. IPD Sharing Statement
Citations:
PubMed Identifier
25408598
Citation
Alhekeir DF, Al-Sarhan RA, Al Mashaan AF. Porcelain laminate veneers: Clinical survey for evaluation of failure. Saudi Dent J. 2014 Apr;26(2):63-7. doi: 10.1016/j.sdentj.2014.02.003. Epub 2014 Mar 26.
Results Reference
result
PubMed Identifier
20621154
Citation
Chu SJ, Trushkowsky RD, Paravina RD. Dental color matching instruments and systems. Review of clinical and research aspects. J Dent. 2010;38 Suppl 2:e2-16. doi: 10.1016/j.jdent.2010.07.001. Epub 2010 Aug 1.
Results Reference
result
PubMed Identifier
20122985
Citation
Stevenson B, Ibbetson R. The effect of the substructure on the colour of samples/restorations veneered with ceramic: a literature review. J Dent. 2010 May;38(5):361-8. doi: 10.1016/j.jdent.2010.01.009. Epub 2010 Feb 1.
Results Reference
result
Learn more about this trial
Clinical Performance of Ceramic Laminate Veneers Made With Celtra Duo Press and IPS e.Max Press Ceramic
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