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

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

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

Study Overview

• Status: Unknown
• Conditions: Wear of the Natural Enamel
• Intervention / Treatment: Other: zirconia reinforced lithium silicate glass ceramic

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: Interventional
• Enrollment (Anticipated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: esraa mohamed hany; Phone Number: 00201005669044; Email: esraamhany@gmail.com
• Study Contact Backup: Name: hesham katamesh, professor; Phone Number: 00201222102001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
wear of the antagonist natural enamel	loss of opposing tooth structure which will be measured by 3D Profilometer	from baseline till one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction	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.	from baseline till one year

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2018
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: October 2, 2018
• First Submitted That Met QC Criteria: October 3, 2018
• First Posted (Actual): October 5, 2018

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 5, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Antimanic Agents; Lithium Carbonate
• Other Study ID Numbers: CEBD-CU-2018-10-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: conditions and factors which increase degree and progression of wear and clinical behavior of monolithic zirconia and zirconia reinforced lithium silicate restorations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No