One Year Clinical Evaluation of Shade Matching and Patien... | NCT04738526

Studies
One Year Clinical Evaluation of Shade Matching and Patient Satisfaction of New Gradient Technology Monolithic Zirconia (5Y-TZP\3Y-TZP) Compared to Lithium Disilicate Crowns in Dental Esthetic Zone

NCT04738526

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Feb 5, 2021Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Decayed Teeth
Malposed Teeth
Endodontically Treated Teeth
Teeth Restored With Large Filling Restorations
Single Anterior Crowns
Single Premolars Crowns

Interventions

lithium disilicate (IPS e-max) ceramic crown
New gradient technology zirconia (5Y-TZP\ 3Y-TZP) IPS e.max ZirCad Prime ceramic crown
natural tooth

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2021Estimated

Primary Completion Date

Mar 1, 2022Estimated

Completion Date

Jun 1, 2022Estimated

First Submitted Date

Jan 31, 2021

First Submission Date that Met QC Criteria

Jan 31, 2021

First Posted Date

Feb 4, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2021

Last Update Posted Date

Feb 5, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Although zirconia is widely used for fabrication of restorations, the 3Y-TZP zirconia where limited for posterior region for its high strength and bad esthetic. While the 5Y-TZP zirconia is limited for the anterior region due to its good esthetic and low strength. For that reason, the introduction of the new gradient technology zirconia (5Y-TZP\3Y-TZP) (IPS e.max Zircad Prime) has offered a solution to solve this problem be combining the esthetic of 5Y-TZP and the high strength of 3Y-TZP. The aim of the present study is to evaluate shade matching to natural tooth and patient satisfaction of the new gradient technology zirconia (5Y-TZP\3Y-TZP) and lithium disilicate ceramic crowns.

Detailed Description

Restorative dentistry is a mix of science and art. The success of restorative dentistry is determined on the basis of functional and esthetic results. Closely matching natural teeth with an artificial restoration can be one of the most challenging procedures in restorative dentistry. Natural teeth vary greatly in color and shape.The color of a ceramic restoration is affected by the shade of the ceramic material, its thickness, and, the color of the underlying material. The restoration's color is influenced by ceramic firing temperature, the color of the prepared tooth, translucency and thickness of veneering porcelain.

The rational of this study is newly introduced gradient technology zirconia (5Y-TZP\3Y-TZP) (IPS e.max Zircad Prime) with improved optical properties to solve the drawbacks of esthetic properties of zirconia.

Null hypothesis of the study will be:

There would be no difference in shade matching of the new gradient technology zirconia (5Y-TZP\3Y-TZP) and lithium disilicate ceramic crowns used in the esthetic zone.
There would be no difference in patient satisfaction of new gradient technology zirconia (5Y-TZP\3Y-TZP) and lithium disilicate ceramic crowns at baseline, 3, 6, 9, 12 months used in the esthetic zone.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
natural tooth	Active Comparator		Other: natural tooth
lithium disilicate (IPS e-max) ceramic crown	Experimental	monolithic lithium disilicate (IPS e-max) ceramic crown for crowns in esthetic zone	Other: lithium disilicate (IPS e-max) ceramic crown
New gradient technology zirconia (5Y-TZP\ 3Y-TZP) IPS e.max ZirCad Prime ceramic crown	Experimental		Other: New gradient technology zirconia (5Y-TZP\ 3Y-TZP) IPS e.max ZirCad Prime ceramic crown

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lithium disilicate (IPS e-max) ceramic crown	Other	monolithic lithium disilicate ceramic crown	lithium disilicate (IPS e-max) ceramic crown

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
shade match	measured by Modified United States Public Health Service criteria (USPHS criteria) Score Alpha(A):matches tooth Bravo(B):acceptable mismatch Charlie(C):unacceptable mismatch	1 year

Secondary Outcomes

Measure	Description	Time Frame
Shade match	measured by Vita Easyshade V spectrophotometer	1 year

Other Outcomes

Measure	Description	Time Frame
Patient satisfaction	measured by Visual Analog Scale Questionnaire (VAS Questionnaire) ("0" unsatisfied - "10" satisfied)	1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

From 21-50 years old, be able to read and sign the informed consent document.
Have no active periodontal or pulpal diseases, have teeth with good restorations.
Psychologically and physically able to withstand conventional dental procedures.
Patient with thick gingival biotype.
Patients with teeth problems indicated for single all ceramic restoration in esthetic zone
1. Badly decayed teeth.
2. Teeth restored with large filling restorations.
3. Endodontically treated teeth.
4. Malformed teeth.
5. Malposed teeth (Tilted, over-erupted, rotated, etc.).
6. Spacing between teeth in esthetic zone.
Able to return for follow-up examinations and evaluation.

Exclusion Criteria:

Patient less than 21 or more than 50 years.
Patient with active resistant periodontal diseases.
Patients with poor oral hygiene and uncooperative patients.
Pregnant women.
Patients in the growth stage with partially erupted teeth.
Psychiatric problems or unrealistic expectations.
Patient with periodontal problems.
Patients with malocclusion or parafunctional habits.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Noha Khaled Eid, M.D.s	Contact	01223976400		noha.khaled@dentistry.cu.edu.eg
Rana Mahmoud sherif, professor	Contact

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D003731	Dental Caries
D019553	Tooth, Nonvital

ID	Term
D017001	Tooth Demineralization
D014076	Tooth Diseases
D009057	Stomatognathic Diseases
D003788	Dental Pulp Diseases