Clinical Evaluation and Patient Satisfaction of Shade Matching Between Natural Teeth and Monolithic All-ceramic Crowns Fabricated From Two Materials

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Primary Purpose

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Celtra Press

About this trial

This is an interventional treatment trial for Natural Optical Properties

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1. Age range of the patients from 20-45 years old; able to read and sign the informed consent document, illiterate patient will be avoided.
2. Patients able physically and psychologically to tolerate conventional restorative procedures.
3. Patients with no active periodontal or pulpal diseases, having teeth with good restorations.
4. Patients with teeth problems indicated for full coverage restoration ( coronal fracture where partial coverage would lack retention, malposed or malformed teeth).
5. Patients with root canal treated teeth requiring full coverage restorations with contralatral tooth not filled orfractured.
6. Patients willing to return for follow-up examinations and evaluation.

Exclusion Criteria:

Patients in the growth stage with partially erupted teeth.
Patients with poor oral hygiene and motivation.
Pregnant women's to avoid any complication that may occur in dental office due to pregnancy or due to injected anesthetic solution.
Patients with psychiatric problems or unrealistic expectation
Patients have no opposite occluding dentition in the area intended for restoration\
Patients suffer from parafunctional habits.
deep discoloration of abutment .
Smokers and heavy caffeine consumers.
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Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

IPS e.max Press(lithium di silicate)

Celtra Press

Arm Description

Lithium disilicate reinforced glass ceramics are available in the market in two forms according to the technique of manufacturing, either heat pressed ingots or CAD/CAM blocks for milling. The heat pressed lithium disilicate glass ceramic consists of approximately 70% lithium disilicatecrystals(the main crystal phase) having a needle like shape that are embedded in a glassy matrix. The crystals length is about 3 to 6 μm. The heat pressed ingots are fully crystallized and the restoration is fabricated by the lost wax technique where the lithium disilicate ingots are pressed into the investment mold at high temperature. The pressed lithium disilicate has strong flexural strength values(range 400 ± 40 MPa)

new class of zirconia-reinforced lithium silicate material available to labs for pressing. This unique material provides top aesthetics and is virtually impossible to tell apart from a natural tooth. Celtra Press is a multiphase ceramic consisting of a glass matrix and lithium disilicate crystals having a crystal length of about 1.5 µm plus nano-scale lithium phosphate . In addition to Li2O and SiO2, Celtra Press contains about 10% zirconia (ZrO2), which is dissolved completely in the glass phase rather than in crystalline form. Celtra Press is characterized by a high strength of about 500 MPa and excellent flow properties during pressing.

Outcomes

Primary Outcome Measures

Color match

using USPHS scoring system

Secondary Outcome Measures

Patient satisfaction

Patient satisfaction using Visual Analogue scale- Binary (Satisfied or not satisfied)

Full Information

NCT ID

NCT03779607

First Posted

November 12, 2018

Last Updated

January 17, 2019

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03779607

Brief Title

Clinical Evaluation and Patient Satisfaction of Shade Matching Between Natural Teeth and Monolithic All-ceramic Crowns Fabricated From Two Materials

Official Title

Clinical Evaluation and Patient Satisfaction Ofshade Matching Between Natural Teeth and Monolithic All-ceramic Crowns Fabricated From Two Materials (Randomized Controlled Clinical Trial)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 2019 (Anticipated)

Primary Completion Date

November 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

evaluation of color difference between zirconia reinforced lithium silicate (celtra press) VS lithium disilicate (Emax) in relation to natural tooth structure to determine which monolithic material will provide restoration with exact shade and optical properties as natural tooth structure.

Detailed Description

eligible patients will be randomized in 2 equal group between study group (celtra press) and control group (Emax) . Single tooth in esthetic zone requiring full coverage crown is prepared to receive an all ceramic crown of . Grouping: The crowns will be divided into two groups: I:Teeth receiving crowns fabricated from IPS emax press ( ivoclarvivadent) II:Teeth receiving crowns fabricatedfrom Celtrapress(dentsplysirona). Shade will be measured using intraoral spectrophotometer and evaluated. The color difference (ΔE ) will be calculated for each sample using the following equation: ΔE =[(ΔL*)²+(Δa*)² + (Δb*)²]½ ΔE (perceptibility threshold ) will be evaluated for each group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Natural Optical Properties

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IPS e.max Press(lithium di silicate)

Arm Type

Active Comparator

Arm Description

Lithium disilicate reinforced glass ceramics are available in the market in two forms according to the technique of manufacturing, either heat pressed ingots or CAD/CAM blocks for milling. The heat pressed lithium disilicate glass ceramic consists of approximately 70% lithium disilicatecrystals(the main crystal phase) having a needle like shape that are embedded in a glassy matrix. The crystals length is about 3 to 6 μm. The heat pressed ingots are fully crystallized and the restoration is fabricated by the lost wax technique where the lithium disilicate ingots are pressed into the investment mold at high temperature. The pressed lithium disilicate has strong flexural strength values(range 400 ± 40 MPa)

Arm Title

Celtra Press

Arm Type

Experimental

Arm Description

new class of zirconia-reinforced lithium silicate material available to labs for pressing. This unique material provides top aesthetics and is virtually impossible to tell apart from a natural tooth. Celtra Press is a multiphase ceramic consisting of a glass matrix and lithium disilicate crystals having a crystal length of about 1.5 µm plus nano-scale lithium phosphate . In addition to Li2O and SiO2, Celtra Press contains about 10% zirconia (ZrO2), which is dissolved completely in the glass phase rather than in crystalline form. Celtra Press is characterized by a high strength of about 500 MPa and excellent flow properties during pressing.

Intervention Type

Other

Intervention Name(s)

Celtra Press

Intervention Description

new class of zirconia-reinforced lithium silicate material available to labs for pressing. This unique material provides top aesthetics and is virtually impossible to tell apart from a natural tooth. Celtra Press is a multiphase ceramic consisting of a glass matrix and lithium disilicate crystals having a crystal length of about 1.5 µm plus nano-scale lithium phosphate . In addition to Li2O and SiO2, Celtra Press contains about 10% zirconia (ZrO2), which is dissolved completely in the glass phase rather than in crystalline form. Celtra Press is characterized by a high strength of about 500 MPa and excellent flow properties during pressing.

Primary Outcome Measure Information:

Title

Color match

Description

using USPHS scoring system

Time Frame

immediately after crown cementation

Secondary Outcome Measure Information:

Title

Patient satisfaction

Description

Patient satisfaction using Visual Analogue scale- Binary (Satisfied or not satisfied)

Time Frame

immediately after crown cementation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 1. Age range of the patients from 20-45 years old; able to read and sign the informed consent document, illiterate patient will be avoided. 2. Patients able physically and psychologically to tolerate conventional restorative procedures. 3. Patients with no active periodontal or pulpal diseases, having teeth with good restorations. 4. Patients with teeth problems indicated for full coverage restoration ( coronal fracture where partial coverage would lack retention, malposed or malformed teeth). 5. Patients with root canal treated teeth requiring full coverage restorations with contralatral tooth not filled orfractured. 6. Patients willing to return for follow-up examinations and evaluation. Exclusion Criteria: Patients in the growth stage with partially erupted teeth. Patients with poor oral hygiene and motivation. Pregnant women's to avoid any complication that may occur in dental office due to pregnancy or due to injected anesthetic solution. Patients with psychiatric problems or unrealistic expectation Patients have no opposite occluding dentition in the area intended for restoration\ Patients suffer from parafunctional habits. deep discoloration of abutment . Smokers and heavy caffeine consumers. -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

mohamed bekhiet, master degree student

Phone

01224238808

Email

mohamed.bekhet@dentistry.cu.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohamed zamzam, professor

Organizational Affiliation

Fixed Prosthodontics Faculty of Oral and dental medicine Cairo University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Maha Taymour, Associate professor

Organizational Affiliation

Fixed Prosthodontics Faculty of Oral and dental medicine Cairo University

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Natural Optical Properties

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial