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One Year Clinical Evaluation of IPS Empress CAD Versus Polished Celtra Duo Ceramic 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: NCT03136276
Recruitment Status : Unknown
Verified April 2017 by Hayat Ibrahim Mahrous Ibrahim, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : May 2, 2017
Last Update Posted : May 2, 2017
Sponsor:
Information provided by (Responsible Party):
Hayat Ibrahim Mahrous Ibrahim, Cairo University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tooth Discoloration Tooth Fractures Diastema Other: IPS Empress CAD Other: polished Celtra Duo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: double blind
Primary Purpose: Treatment
Official Title: One Year Clinical Evaluation of IPS Empress CAD Versus Polished Celtra Duo Ceramic Laminate Veneers
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

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 Name: 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 Name: zirconia reinforced lithium silicate (ZLS)




Primary Outcome Measures :
  1. Fracture [ Time Frame: 1 year ]
    number of fractured laminates



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03136276


Contacts
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Contact: Hayat El-Banna, M.D.s 01001248734 hayat.elbanna@dentistry.cu.edu.eg
Contact: Jylan EL-Guindy

Sponsors and Collaborators
Cairo University

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Responsible Party: Hayat Ibrahim Mahrous Ibrahim, assisstant lecturer, fixed prosthodontic department, faculty of oral and dental medicine, Cairo University
ClinicalTrials.gov Identifier: NCT03136276     History of Changes
Other Study ID Numbers: 19786
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Tooth Discoloration
Tooth Fractures
Diastema
Tooth Diseases
Stomatognathic Diseases
Tooth Injuries
Wounds and Injuries
Tooth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors