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Effect of Preparation Design on the Functional and Esthetic Outcome of CAD/CAM Lithium Disilicate Laminate Veneers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04840524
Recruitment Status : Active, not recruiting
First Posted : April 12, 2021
Last Update Posted : June 18, 2021
Sponsor:
Information provided by (Responsible Party):
Baher Ahmed Moustafa Ali, Cairo University

Study Description
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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

Condition or disease Intervention/treatment Phase
Dental Disorders Hard Tissues of Teeth Tooth Discoloration Procedure: Laminate veneers preparation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Preparation Design on the Functional and Esthetic Outcome of CAD/CAM Lithium Disilicate Laminate Veneers (Split Mouth Randomized Clinical Trial)
Actual Study Start Date : January 26, 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : July 2023
Arms and Interventions
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Arm Intervention/treatment
Conventional preparation design (Chamfer finish line with Butt joint incisal preparation design)
conventional treatment
 Procedure: Laminate veneers preparation
facial laminate veneers teeth preparation
Experimental: New preparation design (Feather edge finish line with feather edge incisal preparation design)
New preparation design
 Procedure: Laminate veneers preparation
facial laminate veneers teeth preparation


Outcome Measures
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Primary Outcome Measures :
  1. marginal gap distance [ Time Frame: at time of laminate cementation ]
    the gap between the laminate and the prepared tooth is measured before cementation using silicon replica and digital microscope


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04840524


Locations
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Egypt
Faculty of Dentistry - Cairo University
Cairo, Egypt
Sponsors and Collaborators
Cairo University
More Information
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Responsible Party: Baher Ahmed Moustafa Ali, Assosiate lecturer of Fixed Prosthodontics, Cairo University
ClinicalTrials.gov Identifier: NCT04840524    
Other Study ID Numbers: 20-1-21
20-1-21 ( Registry Identifier: Research Ethics Committee )
First Posted: April 12, 2021    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Baher Ahmed Moustafa Ali, Cairo University:
Laminates
Vertical preparation
veneers
Additional relevant MeSH terms:
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Tooth Discoloration
Tooth Diseases
Stomatognathic Diseases