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

Effect of Preparation Design on the Functional and Esthetic Outcome of CAD/CAM Lithium Disilicate Laminate Veneers (Split Mouth Randomized Clinical Trial)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Tooth Discoloration; Dental Disorders Hard Tissues of Teeth
• Intervention / Treatment: Procedure: Laminate veneers preparation

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry - Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
marginal gap distance	the gap between the laminate and the prepared tooth is measured before cementation using silicon replica and digital microscope	at time of laminate cementation

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2021
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: April 7, 2021
• First Submitted That Met QC Criteria: April 7, 2021
• First Posted (Actual): April 12, 2021

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 17, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: veneers; Laminates; Vertical preparation
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Discoloration
• Other Study ID Numbers: 20-1-21 (Registry Identifier: Research Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No