Evaluation of Patient Satisfaction and Color Difference Between Natural Teeth and Monolithic All-ceramic Crowns Fabricated From Celtra Press Treated With Different Surface Finishing Protocols

March 1, 2019 updated by: Nurhan Sayed Saleh Ahmed, Cairo University

Evaluation of Patient Satisfaction and Color Difference Between Natural Teeth and Monolithic All-ceramic Crowns Fabricated From Zirconia Reinforced Lithium Silicate Ceramics "Celtra Press" Treated With Different Surface Finishing Protocols.

investigating the effect of glazing and polishing on the color difference between natural teeth and all ceramic crowns made from celtra press (zirconia reinforced lithium silicate ceramic).

Study Overview

Detailed Description

Two groups of patients will be selected according to special inclusion criteria N=5 in each group total of 10 patients, one of the two groups will receive a glazed zirconia reinforced lithium silicate ''celtra press'' crowns and the other group will receive a polished ones of the same material , after crowns delivery color difference (ΔE) between the natural teeth and the celtra press crown will be measured by a spectrophotometer device (intra oral) and patient satisfaction will be recorded.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age range of the patients from 20-45 years old; able to read and sign the informed consent document, illiterate patient will be avoided.
  • Patients able physically and psychologically to tolerate conventional restorative procedures.
  • Patients with no active periodontal or pulpal diseases, having teeth with good restorations.
  • Patients with teeth problems indicated for full coverage restoration ( coronal fracture where partial coverage would lack retention, malposed or malformed teeth).
  • Patients with root canal treated teeth requiring full coverage restorations with contralatral tooth not filled or fractured.
  • 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
  • Deep discoloration of abutment .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: polished celtra press full coverage crowns
a full coverage crown in esthetic area made from celtra press ceramic( zirconia reinforced lithium silicate) and finished by just polishing
a full coverage crown in esthetic area made from celtra press ceramic( zirconia reinforced lithium silicate) and finished by just polishing
Other Names:
  • polished all ceramic crown
Experimental: glazed celtra press full coverage crowns
a full coverage crown in esthetic area made from celtra press ceramic( zirconia reinforced lithium silicate) and finished by glazing
a full coverage crown in esthetic area made from celtra press ceramic( zirconia reinforced lithium silicate) and finished by glazing
Other Names:
  • glazed all ceramic crown
Active Comparator: contralateral natural teeth
the poilshed and glazed all ceramic crowns will be compared by the contralateral natural teeth
the polished and glazed all ceramic crowns will be compared by the contralateral natural teeth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
color match
Time Frame: immediately after crown delivery

Color match will be measured using "United states pulplic health service " system .

Scale system :

  • Alpha : Excellent colour match and shade between restoration and adjacent tooth, restoration almost invisible
  • Bravo : Slightly mismatching between the restoration and the adjacent tooth, which is in the normal range of tooth colour, translucence, and/or shade
  • Charlie : Obvious mismatch, beyond the normal range
  • Delta : Gross mismatch/aesthetically displeasing colour, shade, and/or translucence
immediately after crown delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Color difference
Time Frame: immediately after crown delivery
The color difference (ΔE) will be measured using spectrophotometer
immediately after crown delivery

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2019

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

January 17, 2019

First Submitted That Met QC Criteria

January 22, 2019

First Posted (Actual)

January 23, 2019

Study Record Updates

Last Update Posted (Actual)

March 4, 2019

Last Update Submitted That Met QC Criteria

March 1, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CEBD-CU-2018-09-23

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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