Back to resultsEffect of Preparation Design on the Functional and Esthetic Outcome of CAD/CAM Lithium Disilicate Laminate Veneers
Primary Purpose
Dental Disorders Hard Tissues of Teeth, Tooth Discoloration
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Laminate veneers preparation
Sponsored by
About this trial
This is an interventional treatment trial for Dental Disorders Hard Tissues of Teeth focused on measuring Laminates, Vertical preparation, veneers
Eligibility Criteria
Inclusion Criteria:
- From 18-60 years old, and able to read and sign the informed consent document.
- Patients with teeth problems indicated for laminate veneers.
- Physically and psychologically able to tolerate conventional restorative procedures.
- Have no active periodontal or pulpal diseases.
- Maintenance of good oral hygiene .
- Willing to return for follow-up examinations and evaluation.
Exclusion Criteria:
- Patients in the growth stage with partially erupted teeth.
- Patients with para-functional habits.
- Cases that need modification in the incisal edge.
- Patients with poor oral hygiene and motivation .
- Psychiatric problems or unrealistic expectations.
Sites / Locations
- Faculty of Dentistry - Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Conventional preparation design (Chamfer finish line with Butt joint incisal preparation design)
New preparation design (Feather edge finish line with feather edge incisal preparation design)
Arm Description
conventional treatment
New preparation design
Outcomes
Primary Outcome Measures
marginal gap distance
the gap between the laminate and the prepared tooth is measured before cementation using silicon replica and digital microscope
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04840524
Brief Title
Effect of Preparation Design on the Functional and Esthetic Outcome of CAD/CAM Lithium Disilicate Laminate Veneers
Official Title
Effect of Preparation Design on the Functional and Esthetic Outcome of CAD/CAM Lithium Disilicate Laminate Veneers (Split Mouth Randomized Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 26, 2021 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
July 2023 (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
Yes
5. Study Description
Brief Summary
Conservatism is considered the main concern in any treatment plan, the feather edge preparation design of laminate veneers have been introduced yet clinical studies are lacking to evaluate their clinical performance.The aim of this study is to evaluate the effect of the two different preparation designs on the functional and esthetic outcome of laminate veneers in terms of marginal adaptation, retention, fracture, marginal discoloration and patient satisfaction
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Disorders Hard Tissues of Teeth, Tooth Discoloration
Keywords
Laminates, Vertical preparation, veneers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional preparation design (Chamfer finish line with Butt joint incisal preparation design)
Arm Type
Other
Arm Description
conventional treatment
Arm Title
New preparation design (Feather edge finish line with feather edge incisal preparation design)
Arm Type
Experimental
Arm Description
New preparation design
Intervention Type
Procedure
Intervention Name(s)
Laminate veneers preparation
Intervention Description
facial laminate veneers teeth preparation
Primary Outcome Measure Information:
Title
marginal gap distance
Description
the gap between the laminate and the prepared tooth is measured before cementation using silicon replica and digital microscope
Time Frame
at time of laminate cementation
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:
From 18-60 years old, and able to read and sign the informed consent document.
Patients with teeth problems indicated for laminate veneers.
Physically and psychologically able to tolerate conventional restorative procedures.
Have no active periodontal or pulpal diseases.
Maintenance of good oral hygiene .
Willing to return for follow-up examinations and evaluation.
Exclusion Criteria:
Patients in the growth stage with partially erupted teeth.
Patients with para-functional habits.
Cases that need modification in the incisal edge.
Patients with poor oral hygiene and motivation .
Psychiatric problems or unrealistic expectations.
Facility Information:
Facility Name
Faculty of Dentistry - Cairo University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Preparation Design on the Functional and Esthetic Outcome of CAD/CAM Lithium Disilicate Laminate Veneers
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