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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

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ClinicalTrials.gov Identifier: NCT03813628
Recruitment Status : Not yet recruiting
First Posted : January 23, 2019
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
Nurhan Sayed Saleh Ahmed, Cairo University

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Natural Optical Properties Other: polished celtra press full coverage crown Other: glazed celtra press full coverage crowns Other: contralateral natural teeth Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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
Other: polished celtra press full coverage crown
a full coverage crown in esthetic area made from celtra press ceramic( zirconia reinforced lithium silicate) and finished by just polishing
Other Name: 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
Other: 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
Other Name: glazed all ceramic crown

Active Comparator: contralateral natural teeth
the poilshed and glazed all ceramic crowns will be compared by the contralateral natural teeth
Other: contralateral natural teeth
the polished and glazed all ceramic crowns will be compared by the contralateral natural teeth




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Color difference [ Time Frame: immediately after crown delivery ]
    The color difference (ΔE) will be measured using spectrophotometer


Other Outcome Measures:
  1. patient satisfaction [ Time Frame: immediately after crown delivery ]
    Patient satisfaction using Visual Analogue scale- Binary (Satisfied or not satisfied)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03813628


Contacts
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Contact: nourhan sayed 01117911384 nourhan.sayed@dentistry.cu.edu.eg

Sponsors and Collaborators
Cairo University

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Responsible Party: Nurhan Sayed Saleh Ahmed, Principal investigator - Fixed prosthodontic department, faculty of oral and dental medicine, Cairo University
ClinicalTrials.gov Identifier: NCT03813628     History of Changes
Other Study ID Numbers: CEBD-CU-2018-09-23
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nurhan Sayed Saleh Ahmed, Cairo University:
celtra press

Additional relevant MeSH terms:
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Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Lithium Carbonate
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs