Back to resultsWear of Enamel Antagonist to Two Different Types of Monolithic Zirconia Monolithic Zirconia
Primary Purpose
Wear, Occlusal
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Newly Introduced Gradient Monolithic Zirconia
Full Strength Monolithic Zirconia
Sponsored by
About this trial
This is an interventional treatment trial for Wear, Occlusal
Eligibility Criteria
Inclusion Criteria:
-
All subjects are required to be:
- From 18-50 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 planned for a single coverage restoration in the posterior area.
- Patients with a natural (not crowned) opposing antagonist.
- Able to return for follow-up examinations and evaluation.
Exclusion Criteria:
- Patient less than 18 or more than 50 years 2. Patients with severe clenching or bruxing habits. 3. Patient with active resistant periodontal diseases 4. Patients with poor oral hygiene and uncooperative patients 5. Pregnant women 6. Patients in the growth stage with partially erupted teeth 7. Psychiatric problems or unrealistic expectations 8. Lack of opposing dentition at the area of interest. 9. Presence of dental prosthesis in the opposing arch at the area of interest.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
tested material
comparator material
Arm Description
Newly Introduced Gradient Monolithic Zirconia (Intervention)
Full Strength Monolithic Zirconia (Comparator)
Outcomes
Primary Outcome Measures
Enamel wear of teeth opposing the restorations to be tested opposing to tested restorations
measured by Geomagic professional software
Secondary Outcome Measures
Wear of restorations to tested opposed to natural teeth
measured by Geomagic professional software
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04798300
Brief Title
Wear of Enamel Antagonist to Two Different Types of Monolithic Zirconia Monolithic Zirconia
Official Title
Wear of Enamel Antagonist to Two Different Types of Monolithic Zirconia: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2021 (Anticipated)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 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 the present study is to evaluate the wear of enamel opposed by Newly Introduced Gradient Monolithic Zirconia compared to that of enamel opposed by Full Strength Monolithic Zirconia
Detailed Description
The aim of the present study is to evaluate the wear of enamel opposed by Newly Introduced Gradient Monolithic Zirconia compared to that of enamel opposed by Full Strength Monolithic Zirconia Teeth preparation and impressions, placement and permanent cementation of the final restoration using resin cement, and optical scanning of both the restoration and the opposing tooth. Follow up postoperatively after six and twelve months, and optical scanning of both the restoration and the opposing tooth.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wear, Occlusal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
tested material
Arm Type
Other
Arm Description
Newly Introduced Gradient Monolithic Zirconia (Intervention)
Arm Title
comparator material
Arm Type
Active Comparator
Arm Description
Full Strength Monolithic Zirconia (Comparator)
Intervention Type
Procedure
Intervention Name(s)
Newly Introduced Gradient Monolithic Zirconia
Intervention Description
Fabrication of full-coverage crowns over posterior teeth using Newly Introduced Gradient Monolithic Zirconia to measure wear
Intervention Type
Procedure
Intervention Name(s)
Full Strength Monolithic Zirconia
Intervention Description
Fabrication of full-coverage crowns over posterior teeth using Full Strength Monolithic Zirconia to measure wear
Primary Outcome Measure Information:
Title
Enamel wear of teeth opposing the restorations to be tested opposing to tested restorations
Description
measured by Geomagic professional software
Time Frame
one year
Secondary Outcome Measure Information:
Title
Wear of restorations to tested opposed to natural teeth
Description
measured by Geomagic professional software
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
-
All subjects are required to be:
From 18-50 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 planned for a single coverage restoration in the posterior area.
Patients with a natural (not crowned) opposing antagonist.
Able to return for follow-up examinations and evaluation.
Exclusion Criteria:
Patient less than 18 or more than 50 years 2. Patients with severe clenching or bruxing habits. 3. Patient with active resistant periodontal diseases 4. Patients with poor oral hygiene and uncooperative patients 5. Pregnant women 6. Patients in the growth stage with partially erupted teeth 7. Psychiatric problems or unrealistic expectations 8. Lack of opposing dentition at the area of interest. 9. Presence of dental prosthesis in the opposing arch at the area of interest.
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Wear of Enamel Antagonist to Two Different Types of Monolithic Zirconia Monolithic Zirconia
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