- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04798300
Wear of Enamel Antagonist to Two Different Types of Monolithic Zirconia Monolithic Zirconia
June 16, 2021 updated by: Sara Ismail Mohamed Hussein, Cairo University
Wear of Enamel Antagonist to Two Different Types of Monolithic Zirconia: A Randomized Clinical Trial
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
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
26
Phase
- Not Applicable
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
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
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 |
---|---|
Other: tested material
Newly Introduced Gradient Monolithic Zirconia (Intervention)
|
Fabrication of full-coverage crowns over posterior teeth using Newly Introduced Gradient Monolithic Zirconia to measure wear
|
Active Comparator: comparator material
Full Strength Monolithic Zirconia (Comparator)
|
Fabrication of full-coverage crowns over posterior teeth using Full Strength Monolithic Zirconia to measure wear
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Enamel wear of teeth opposing the restorations to be tested opposing to tested restorations
Time Frame: one year
|
measured by Geomagic professional software
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wear of restorations to tested opposed to natural teeth
Time Frame: one year
|
measured by Geomagic professional software
|
one year
|
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)
September 1, 2021
Primary Completion (Anticipated)
September 1, 2022
Study Completion (Anticipated)
September 1, 2022
Study Registration Dates
First Submitted
January 28, 2021
First Submitted That Met QC Criteria
March 12, 2021
First Posted (Actual)
March 15, 2021
Study Record Updates
Last Update Posted (Actual)
June 18, 2021
Last Update Submitted That Met QC Criteria
June 16, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 171020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
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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