Color Stability of E.Max CAD Laminate Veneers Cemented With Light Cure Versus Dual Cure Amine Free Adhesive Resin Cement
Primary Purpose
Tooth Discoloration
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
E.Max CAD Laminate Veneers cemented with dual cure amine free adhesive resin cement
E.Max CAD Laminate Veneers cemented with light cured adhesive resin cement
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
dual cure amine free adhesive resin cement
light cured adhesive resin cement
Arm Description
resin cement that get activated by both light and chemicals
resin cement that only get activated by light
Outcomes
Primary Outcome Measures
Color stability assessed clinically using easy shade vita device
Color stability
Secondary Outcome Measures
Patient satisfaction assessed using a Questionnaire
Questionnaire for the patient satisfaction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02943395
Brief Title
Color Stability of E.Max CAD Laminate Veneers Cemented With Light Cure Versus Dual Cure Amine Free Adhesive Resin Cement
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
5. Study Description
Brief Summary
Light curing cements used for laminate veneers may be not totally cured in certain areas, so dual cured resin cements may solve this problem yet the dual cured cements containing amines cause yellowish discoloration of the veneers after time.
A new dual cured cement which is amine free is introduced so the investigators have to try it clinically using parallel groups in 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
dual cure amine free adhesive resin cement
Arm Type
Experimental
Arm Description
resin cement that get activated by both light and chemicals
Arm Title
light cured adhesive resin cement
Arm Type
Active Comparator
Arm Description
resin cement that only get activated by light
Intervention Type
Other
Intervention Name(s)
E.Max CAD Laminate Veneers cemented with dual cure amine free adhesive resin cement
Intervention Type
Other
Intervention Name(s)
E.Max CAD Laminate Veneers cemented with light cured adhesive resin cement
Primary Outcome Measure Information:
Title
Color stability assessed clinically using easy shade vita device
Description
Color stability
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Patient satisfaction assessed using a Questionnaire
Description
Questionnaire for the 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud Elkomy, B.D.s
Phone
01113735370
Email
mahmoud.hossam919@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jylan elguindy
12. IPD Sharing Statement
Citations:
PubMed Identifier
24118675
Citation
Magalhaes AP, Cardoso Pde C, de Souza JB, Fonseca RB, Pires-de-Souza Fde C, Lopez LG. Influence of activation mode of resin cement on the shade of porcelain veneers. J Prosthodont. 2014 Jun;23(4):291-5. doi: 10.1111/jopr.12098. Epub 2013 Oct 7.
Results Reference
background
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
Learn more about this trial
Color Stability of E.Max CAD Laminate Veneers Cemented With Light Cure Versus Dual Cure Amine Free Adhesive Resin Cement
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