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Evaluation of Antagonist Wear Behavior and Patient Satisfaction of Zirconia Reinforced Lithium Silicate Glass When Compared to Monolithic Zirconia

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ClinicalTrials.gov Identifier: NCT03697018
Recruitment Status : Unknown
Verified October 2018 by Esraa Mohamed Hany, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : October 5, 2018
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Esraa Mohamed Hany, Cairo University

Study Description
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Brief Summary:
evaluation of wear behavior and patient satisfaction of monolithic zirconia and zirconia reinforced glass crowns after follow-up periods 0,3,6,12 months.

Condition or disease Intervention/treatment Phase
Wear of the Natural Enamel Other: zirconia reinforced lithium silicate glass ceramic Not Applicable

Detailed Description:
two groups of patients will be selected according to special inclusion criteria n=13 in each group total of 26. each group will receive one of the crowns used in this study either ( monolithic zirconia or zirconia reinforced lithium silicate glass) after crown delivery wear and patient satisfaction will be recorded at 0,3,6,12 moths follow-up periods.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: double blind
Primary Purpose: Treatment
Official Title: Evaluation of Antagonist Wear Behavior and Patient Satisfaction of Monolithic Zirconia Versus Lithium Silicate Zirconia Crowns
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: zirconia reinforced lithium silicate glass ceramic
It represent a new generation of glass ceramic material, enriched with zirconia (10% by weight), the material offers natural esthetics with successful outcome.
 Other: zirconia reinforced lithium silicate glass ceramic
It represent a new generation of glass ceramic material. Using an innovative manufacturing process the glass ceramic is enriched with zirconia (10% by weight) for dental CAD/CAM applications for the fabrication of inlays, onlays, crowns and anterior and posterior single tooth restorations on implant abutments.
Active Comparator: monolithic zirconia
Zirconia or zirconium dioxide (ZrO2) is a highly attractive ceramic material in prosthodontics due to its excellent mechanical properties. It is widely used to build prosthetic devices.
 Other: zirconia reinforced lithium silicate glass ceramic
It represent a new generation of glass ceramic material. Using an innovative manufacturing process the glass ceramic is enriched with zirconia (10% by weight) for dental CAD/CAM applications for the fabrication of inlays, onlays, crowns and anterior and posterior single tooth restorations on implant abutments.


Outcome Measures
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Primary Outcome Measures :
  1. wear of the antagonist natural enamel [ Time Frame: from baseline till one year ]
    loss of opposing tooth structure which will be measured by 3D Profilometer


Secondary Outcome Measures :
  1. patient satisfaction [ Time Frame: from baseline till one year ]
    visual analogue scale (VAS): scale range from 0-10 for describing the intensity of pain the patient suffering. 0: no pain, 5: moderate pain, 10: unbearable pain.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patient age range from 20-60 to be able to read and write in order to sign the informed consent document.
  2. Patients physically and psychologically able to tolerate conventional restorative procedures.
  3. Patients with no active periodontal and or pulpal diseases, having teeth with good restorations.
  4. Patients with root canal treated teeth requiring full coverage restorations.
  5. Patients indicated for full coverage (e.g. moderate to severe discoloration, coronal fracture, malposed or malformed teeth).
  6. Patients willing to return for follow-up examinations and assessments

Exclusion Criteria:

  1. Patients in the growth stage with partially erupted teeth.
  2. Patient with poor oral hygiene.
  3. Patients with psychiatric problems or unrealistic expectations
  4. Patient with no opposite occluding dentition in the area intended for restoration.
  5. Patient suffering from Para functional habits.
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): NCT03697018


Contacts
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Contact: esraa mohamed hany 00201005669044 esraamhany@gmail.com
Contact: hesham katamesh, professor 00201222102001

Sponsors and Collaborators
Cairo University
More Information
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Responsible Party: Esraa Mohamed Hany, PHD candidate, fixed prosthodontic department, faculty of Oral and dental Medicine, Cairo University
ClinicalTrials.gov Identifier: NCT03697018    
Other Study ID Numbers: CEBD-CU-2018-10-01
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: conditions and factors which increase degree and progression of wear and clinical behavior of monolithic zirconia and zirconia reinforced lithium silicate restorations.

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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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Lithium Carbonate
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs