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

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

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.

Study Overview

• Status: Unknown
• Conditions: Natural Optical Properties
• Intervention / Treatment: Other: Celtra Press

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: mohamed bekhiet, master degree student; Phone Number: 01224238808; Email: mohamed.bekhet@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

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

8. Smokers and heavy caffeine consumers.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: IPS e.max Press(lithium di silicate); 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)	Other: Celtra Press; 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.
EXPERIMENTAL: Celtra Press; 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.	Other: Celtra Press; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Color match	using USPHS scoring system	immediately after crown cementation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Patient satisfaction using Visual Analogue scale- Binary (Satisfied or not satisfied)	immediately after crown cementation

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Mohamed zamzam, professor, Fixed Prosthodontics Faculty of Oral and dental medicine Cairo University; Study Director: Maha Taymour, Associate professor, Fixed Prosthodontics Faculty of Oral and dental medicine Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2019
• Primary Completion (ANTICIPATED): November 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: November 12, 2018
• First Submitted That Met QC Criteria: December 17, 2018
• First Posted (ACTUAL): December 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 18, 2019
• Last Update Submitted That Met QC Criteria: January 17, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: CEBD-CU-2018-11-13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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