One Year Clinical Evaluation of New Gradient Technology Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns in Dental Esthetic Zone With Vertical Versus Conventional Preparation Techniques
Primary Purpose
Single Anterior Crowns, Badly Decayed Teeth, Endodontically Treated Teeth
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Vertical preparation technique
Conventional Preparation technique
Sponsored by
About this trial
This is an interventional treatment trial for Single Anterior Crowns
Eligibility Criteria
Inclusion Criteria:
- From 21-50 years old, be able to read and sign the informed consent document.
- Have no active periodontal or pulpal diseases, have teeth with good restorations.
- Psychologically and physically able to withstand conventional dental procedures.
Patients with teeth problems indicated for all ceramic crowns in esthetic zone;
- Badly decayed teeth
- Teeth restored with large filling restorations
- Endodontically treated teeth
- Malformed teeth
- Malposed teeth (Tilted, over-erupted, rotated, etc.)
- Able to return for follow-up examinations and evaluation.
- Thick gingival biotype.
Exclusion Criteria:
- Patient less than 21or more than 50 years.
- Patient with active resistant periodontal diseases.
- Patients with poor oral hygiene and uncooperative patients.
- Pregnant women.
- Patients in the growth stage with partially erupted teeth.
- Psychiatric problems or unrealistic expectations.
- Patient with periodontal problems.
- Patients with malocclusion or parafunctional habits.
Sites / Locations
- Cairo universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional preparation technique
Vertical preprartion
Arm Description
Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns using conventional preparation technique.
Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns using Vertical preparation technique.
Outcomes
Primary Outcome Measures
Marginal integrity
Measured by using Modified United States Public Health Service criteria (USPHS criteria)
Alpha (A) the explorer does not catch when drawn across the surface of the restoration toward the tooth, or, if the explorer does not catch, there is no visible crevice along the periphery of the restoration (visual inspection explorer)
Bravo (B) the explorer catches and the is visible evidence of the crevice, which the explorer penetrates, indicating that the edge of the restoration does not adapt closely to the tooth structure. The dentin and/or the base is not exposed, and the restoration is not mobile ( visual inspection and explorer)
Charlie (C) the explorer penetrates crevice defect extended to the dento-enamel junction (explorer)
Secondary Outcome Measures
Gingival discoloration
Measured by using Modified United States Public Health Service criteria (USPHS criteria)
Alpha (A) None,
Bravo (B) Slight discoloration, removable by finishing,
Charlie (C) Discoloration, localized not removable,
Delta (D) Strong discoloration in major parts of the margin not removable
Gingival inflammation
Measured by using Modified United States Public Health Service criteria (USPHS criteria) Alpha (A) Non, Bravo (B) Slight, Charlie (C) Moderate, Delta (D) Severe
Restoration color stability
Measured by using Modified United States Public Health Service criteria (USPHS criteria) Alpha(A) No change, Bravo(B) change in comparison to baseline condition
Secondary caries
Measured by using Modified United States Public Health Service criteria (USPHS criteria) Alpha (A) Non, Bravo (B) Caries present
patient satisfaction
Measured by Visual Analog Scale VAS (Questionnaire) a numerical scale from ("0" unsatisfied to "10" satisfied)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04738513
Brief Title
One Year Clinical Evaluation of New Gradient Technology Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns in Dental Esthetic Zone With Vertical Versus Conventional Preparation Techniques
Official Title
One Year Clinical Evaluation of New Gradient Technology Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns in Dental Esthetic Zone With Vertical Versus Conventional Preparation Techniques (Randomized Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Anticipated)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (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
Yes
5. Study Description
Brief Summary
The aim of this study is to evaluate the clinical behavior of zirconia crowns in dental esthetic zone with vertical versus conventional preparation techniques using a new gradient technology monolithic zirconia (5Y-TZP/3Y-TZP).
Detailed Description
Introduction: A good relationship between dental restorations and the periodontium is one of the most important aspects to ensure clinical success both in terms of esthetics and function. Dental preparation for fixed prostheses can take various forms classified as horizontal preparation with a defined margin (chamfer), or vertical, or without a margin/finish line. According to some clinical reports, vertical preparation technique provides an increases in the gingival thickness and a greater stability of the gingival margin. Moreover, vertical preparation is characterized by being more conservative with tooth structure. Also, taking impressions is easier since it is a finish area and not a defined line.
Null hypothesis:
There will be no difference between vertical and conventional preparations in the clinical behavior of zirconia crowns in dental esthetic zone at baseline,3,6,9,12 months evaluation.
There will be no difference between vertical and conventional preparations in the patient satisfaction of zirconia crowns in dental esthetic zone at baseline,3,6,9,12 months evaluation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Single Anterior Crowns, Badly Decayed Teeth, Endodontically Treated Teeth, Spacing Between Anterior Teeth, Malposed Teeth(Tilted,Overerupted,Totated,Etc.)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional preparation technique
Arm Type
Active Comparator
Arm Description
Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns using conventional preparation technique.
Arm Title
Vertical preprartion
Arm Type
Experimental
Arm Description
Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns using Vertical preparation technique.
Intervention Type
Procedure
Intervention Name(s)
Vertical preparation technique
Other Intervention Name(s)
Vertiprep
Intervention Description
Teeth in dental esthetic zone will receive Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns using vertical preparation technique.
Intervention Type
Procedure
Intervention Name(s)
Conventional Preparation technique
Intervention Description
Teeth in dental esthetic zone will receive Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns using conventional preparation technique.
Primary Outcome Measure Information:
Title
Marginal integrity
Description
Measured by using Modified United States Public Health Service criteria (USPHS criteria)
Alpha (A) the explorer does not catch when drawn across the surface of the restoration toward the tooth, or, if the explorer does not catch, there is no visible crevice along the periphery of the restoration (visual inspection explorer)
Bravo (B) the explorer catches and the is visible evidence of the crevice, which the explorer penetrates, indicating that the edge of the restoration does not adapt closely to the tooth structure. The dentin and/or the base is not exposed, and the restoration is not mobile ( visual inspection and explorer)
Charlie (C) the explorer penetrates crevice defect extended to the dento-enamel junction (explorer)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Gingival discoloration
Description
Measured by using Modified United States Public Health Service criteria (USPHS criteria)
Alpha (A) None,
Bravo (B) Slight discoloration, removable by finishing,
Charlie (C) Discoloration, localized not removable,
Delta (D) Strong discoloration in major parts of the margin not removable
Time Frame
1 year
Title
Gingival inflammation
Description
Measured by using Modified United States Public Health Service criteria (USPHS criteria) Alpha (A) Non, Bravo (B) Slight, Charlie (C) Moderate, Delta (D) Severe
Time Frame
1 year
Title
Restoration color stability
Description
Measured by using Modified United States Public Health Service criteria (USPHS criteria) Alpha(A) No change, Bravo(B) change in comparison to baseline condition
Time Frame
1 year
Title
Secondary caries
Description
Measured by using Modified United States Public Health Service criteria (USPHS criteria) Alpha (A) Non, Bravo (B) Caries present
Time Frame
1 year
Title
patient satisfaction
Description
Measured by Visual Analog Scale VAS (Questionnaire) a numerical scale from ("0" unsatisfied to "10" satisfied)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
From 21-50 years old, be able to read and sign the informed consent document.
Have no active periodontal or pulpal diseases, have teeth with good restorations.
Psychologically and physically able to withstand conventional dental procedures.
Patients with teeth problems indicated for all ceramic crowns in esthetic zone;
Badly decayed teeth
Teeth restored with large filling restorations
Endodontically treated teeth
Malformed teeth
Malposed teeth (Tilted, over-erupted, rotated, etc.)
Able to return for follow-up examinations and evaluation.
Thick gingival biotype.
Exclusion Criteria:
Patient less than 21or more than 50 years.
Patient with active resistant periodontal diseases.
Patients with poor oral hygiene and uncooperative patients.
Pregnant women.
Patients in the growth stage with partially erupted teeth.
Psychiatric problems or unrealistic expectations.
Patient with periodontal problems.
Patients with malocclusion or parafunctional habits.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Menna ElGendy, MSD
Phone
00201093302027
Email
mennaelgendy@dentisrty.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Rana Sherif, Professor
Facility Information:
Facility Name
Cairo university
City
Cairo
ZIP/Postal Code
11865
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Menna ElGendy, Master
Phone
00201093302027
Email
mennaelgendy@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name & Degree
Rana Sherif
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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One Year Clinical Evaluation of New Gradient Technology Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns in Dental Esthetic Zone With Vertical Versus Conventional Preparation Techniques
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