One Year Clinical Evaluation of IPS Empress CAD Versus Polished Celtra Duo Ceramic Laminate Veneers

April 27, 2017 updated by: Hayat Ibrahim Mahrous Ibrahim, Cairo University
When restoring teeth with IPS Empress laminate veneers, fracture of restorations may occur. So, material with higher mechanical properties is required. Celtra Duo is a new material with glass ceramics infiltrated by 10% zirconia particles which increase the fracture resistance of the material.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Jylan EL-Guindy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

All subjects are required to be:

  1. From 18-50 years old, be able to read and sign the informed consent document.
  2. Have no active periodontal or pulpal diseases, have teeth with good restorations
  3. Psychologically and physically able to tolerate conventional dental procedures

  4. Patients with teeth problems indicated for laminate veneer:

    1. Discoloration
    2. Fracture not involving more than 50% enamel loss
    3. Mild malposition
    4. Diastema
    5. Enamel fluorosis
    6. Stained or defective restorations
  5. Able to return for follow-up examinations and evaluation

Exclusion Criteria:

  1. Patient with post and core endodontically treated teeth
  2. Patient with fractured teeth of more than 50% enamel loss
  3. Patients with poor oral hygiene and motivation
  4. Pregnant women's
  5. Patients in the growth stage with partially erupted teeth
  6. Psychiatric problems or unrealistic expectations
  7. Lack of opposing dentition in the area of interest
  8. Patients involved in contact sports
  9. Teeth with deep discoloration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: IPS Empress CAD
Leucite Based glass Ceramics which is etchable ceramics and proved to have good success rate if used for laminate veneers
Other: IPS Empress CAD
standard etchable glass ceramics
Other Names:
  • leucite based glass ceramics
Experimental: polished Celtra Duo
Zirconia reinforced lithium silicate, it is a recent material with glass ceramics enriched with 10% zirconia that offers high strength properties
Other: polished Celtra Duo
new glass ceramic material
Other Names:
  • zirconia reinforced lithium silicate (ZLS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fracture
Time Frame: 1 year
number of fractured laminates
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2017

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

April 10, 2017

First Submitted That Met QC Criteria

April 27, 2017

First Posted (Actual)

May 2, 2017

Study Record Updates

Last Update Posted (Actual)

May 2, 2017

Last Update Submitted That Met QC Criteria

April 27, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19786

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tooth Discoloration

Clinical Trials on IPS Empress CAD

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe