- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03813628
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
Status
Unknown
Conditions
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
- Name: nourhan sayed
- Phone Number: 01117911384
- Email: nourhan.sayed@dentistry.cu.edu.eg
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:
|
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:
|
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 :
|
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.
Sponsor
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
Additional Relevant MeSH Terms
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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