Clinical Evaluation of the Fracture Resistance for E-max Cad and Vita Suprinity Laminate Veneers

July 18, 2017 updated by: Ahmed mohamed osman Youssef, Cairo University
Patients need laminate veneer for their teeth usually use Emax CAD as an etchable ceramic. Yet fracture may occur so a stronger material is needed. Vita Suprinity is a recent material with glass ceramic enriched with zirconia (approx. 10% by weight) that offer practices and laboratories a high-strength, zirconia-reinforced lithium silicate ceramic (ZLS) and can be used to fabricate laminate veneers but the investigators have to know clinically it is fracture resistance, so the investigators are going to have Parallel groups in a randomized clinical trial.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Not Applicable

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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
Experimental: Vita suprinity
Vita Suprinity is a recent material with glass ceramic enriched with zirconia (approx. 10 % by weight) that offer practices and laboratories a high-strength, zirconia-reinforced lithium silicate ceramic (ZLS).
Other: Vita suprinity
New glass ceramic material
Other Names:
  • zirconia-reinforced lithium silicate ceramic
Active Comparator: Emax cad
lithium disilicate glass-ceramic which is etchable and proved to have good success rate if used for laminate venners
Other: Emax CAD
standard etchable glass ceramic used for laminate venneers
Other Names:
  • lithium disilicate glass ceramic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fracture resistance assessed by clinical evaluation using dental mirror and probe according to the modified united states public health criteria
Time Frame: 1 Year
clinical evaluation of Fracture resistance
1 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction assessed using a Questionnaire
Time Frame: 1 Year
Questionnaire for patient satisfaction
1 Year

Collaborators and Investigators

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

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2017

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

October 19, 2016

First Submitted That Met QC Criteria

October 19, 2016

First Posted (Estimate)

October 21, 2016

Study Record Updates

Last Update Posted (Actual)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • emax_vita

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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.

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