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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Esraa Mohamed Hany，Cairo University

Tracking Information

First Submitted Date ^ICMJE

October 2, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

October 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

patient satisfaction[ Time Frame: from baseline till one year ]
visual analogue scale for assessment of hypersensitivity, chewing efficiency and patient acceptance from 0-10.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Evaluation of Antagonist Wear Behavior and Patient Satisfaction of Monolithic Zirconia Versus Lithium Silicate Zirconia Crowns

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.

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 Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:double blind
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

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.

Study Arms

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.
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.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 2019

Estimated Primary Completion Date

October 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

20 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

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

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

Esraa Mohamed Hany，Cairo University

Study Sponsor ^ICMJE

Cairo University

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Cairo University

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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