Clinical Evaluation of Wear Behavior of Human Enamel and Chipping of Veneered Zirconia Against Monolithic Zirconia
Primary Purpose
Broken Tooth With Complication, Non Vital Teeth, Mutilated Teeth
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Veneered zirconia
Monolithic zirconia
Sponsored by
About this trial
This is an interventional supportive care trial for Broken Tooth With Complication focused on measuring mutilated, root canal treated teeth, and coronal fracture
Eligibility Criteria
Inclusion Criteria:
- Age range of the patients from 20-60 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 (e.g. Moderate to severe discoloration, coronal fracture where partial coverage would lack retention, malposed or malformed teeth).
- Patients with root canal treated teeth requiring full coverage restorations.
- 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.
- A pregnant woman'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 (patient that has phobia from dental treatments or needle bunch).
- Patients have no opposite occluding dentition in the area intended for restoration.
- Patients suffer from Para functional habits.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
veneered zirconia full coverage restorations
Monolithic zirconia full coverage restorations
Arm Description
InCoris zirconia material (TZI-Densupply sirona)
InCoris (TZI-Densupply sirona)
Outcomes
Primary Outcome Measures
Chipping
chipping of the restoration by modified USPHs criteria as Alpha (Excellent) ideal,Bravo (Acceptable) less than ideal but no modifications required, Charlie (Acceptable but modifications needed) staining or other shade modifications required, and Delta (Unacceptable) remake.
Secondary Outcome Measures
tooth wear
Measuring the effect on natural tooth by modified USPHs criteria as Alpha(Excellent) ideal,Bravo (Acceptable) less than ideal but no modifications requiredCharlie (Acceptable but modifications needed) staining or other shade modifications required, and Delta (Unacceptable) remake.
Full Information
NCT ID
NCT03295513
First Posted
September 15, 2017
Last Updated
September 24, 2017
Sponsor
Cairo University
1. Study Identification
Unique Protocol Identification Number
NCT03295513
Brief Title
Clinical Evaluation of Wear Behavior of Human Enamel and Chipping of Veneered Zirconia Against Monolithic Zirconia
Official Title
Clinical Evaluation of Wear Behavior of Human Enamel and Chipping of Veneered Zirconia Against Monolithic Zirconia (Randomized Controlled Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2017 (Anticipated)
Primary Completion Date
December 1, 2018 (Anticipated)
Study Completion Date
February 1, 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
No
5. Study Description
Brief Summary
The aim of this study is to evaluate chipping and the degree of natural enamel loss opposing to monolithic zirconia compared to veneered zirconia restoration.
Detailed Description
While increase using of zirconia in extra coronal restoration as a substitute for metal ceramic restoration still high rate of technical complications specifically chipping of veneering ceramic and wear of antagonist are usually associated with veneered zirconia restoration which led to development of new monolithic zirconia to overcome these technical complications.
Therefore this study will be conducted to evaluate chipping and wear of antagonist of veneered zirconia versus monolithic zirconia all ceramic crowns in posterior area.
Benefits of the research to the patient:
Patient will receive a restoration with superior function, esthetics, and quality.
It will save teeth such as mutilated teeth, endodontically treated and teeth with massive loss of tooth structure that cannot be restored with direct restoration.
As a result of properly functioning restoration, teeth will be restored with predictable prognosis and the patient will be psychologically improved.
Benefits of the research to the clinician:
Practitioner will have the advantage to clinically assess a new material that can be used in different situations for better function and esthetic outcomes.
It will improve patient confidence with the dentist.
Explanation for choice of comparators:
The use of veneered zirconia is well documented in the literatures as successful restoration modality. A two Clinical performance of two different CAD/CAM-fabricated ceramic crowns revealed no chipping for veneered zirconia.
A 3 years Randomized Controlled Clinical Trial of Zirconia-Ceramic and Metal-Ceramic Posterior Fixed Dental Prostheses reported Alpha Scores A=66.6%, B =25% , C=5.6% and Only D= 2.8 A 5 years prospective clinical study of posterior zirconia fixed dental prosthesis reported Alpha scores greater than 95% indicating no predictable changes during the 5 years Another 3 years Randomized controlled clinical Trial of Posterior veneered zirconia for fixed dental prostheses revealed 20% chipping and also 30% reported alpha for antagonist wear and 70% reported bravo after 3 years of clinical use.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Broken Tooth With Complication, Non Vital Teeth, Mutilated Teeth
Keywords
mutilated, root canal treated teeth, and coronal fracture
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patient will receive a restoration with superior function, esthetics, and quality.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
veneered zirconia full coverage restorations
Arm Type
Active Comparator
Arm Description
InCoris zirconia material (TZI-Densupply sirona)
Arm Title
Monolithic zirconia full coverage restorations
Arm Type
Experimental
Arm Description
InCoris (TZI-Densupply sirona)
Intervention Type
Other
Intervention Name(s)
Veneered zirconia
Intervention Description
he use of veneered zirconia is well documented in the literatures as successful restoration modality. A two Clinical performance of two different CAD/CAM-fabricated ceramic crowns revealed no chipping for veneered zirconia
Intervention Type
Other
Intervention Name(s)
Monolithic zirconia
Intervention Description
Monolithic zirconia product presented a new generation of polycrystalline material by which full anatomical crowns and bridges can be produced
Primary Outcome Measure Information:
Title
Chipping
Description
chipping of the restoration by modified USPHs criteria as Alpha (Excellent) ideal,Bravo (Acceptable) less than ideal but no modifications required, Charlie (Acceptable but modifications needed) staining or other shade modifications required, and Delta (Unacceptable) remake.
Time Frame
12 month
Secondary Outcome Measure Information:
Title
tooth wear
Description
Measuring the effect on natural tooth by modified USPHs criteria as Alpha(Excellent) ideal,Bravo (Acceptable) less than ideal but no modifications requiredCharlie (Acceptable but modifications needed) staining or other shade modifications required, and Delta (Unacceptable) remake.
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age range of the patients from 20-60 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 (e.g. Moderate to severe discoloration, coronal fracture where partial coverage would lack retention, malposed or malformed teeth).
Patients with root canal treated teeth requiring full coverage restorations.
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.
A pregnant woman'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 (patient that has phobia from dental treatments or needle bunch).
Patients have no opposite occluding dentition in the area intended for restoration.
Patients suffer from Para functional habits.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nouran M Ibrahim
Phone
01149928886
Ext
+20
Email
nouran.mahmoud@dentistry.cu.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of Wear Behavior of Human Enamel and Chipping of Veneered Zirconia Against Monolithic Zirconia
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