- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04784676
Internal Fit Evaluation of Indirect Restorations Using Cone Beam CT (CBCT)
March 3, 2021 updated by: Shereen Hafez Ibrahim Mohamed, Cairo University
Internal Fit Evaluation of Indirect Restorations Fabricated From CAD/CAM Composite Blocks Versus Ceramic Blocks in Badly Broken Teeth Using Cone Beam CT (CBCT)
this study was conducted to evaluate the internal fit of indirect restoration fabricated from CAD/CAM composite blocks versus ceramic blocks in badly broken vital teeth using cone beam CT
Study Overview
Status
Terminated
Intervention / Treatment
Detailed Description
two parallel groups (n=42 restorations), patient having badly broken vital teeth minimum of two remaining wall will be randomly enrolled in this trial and receive restoration fabricated either from Grandio composite blocks or E-max ceramic blocks.
internal fit evaluation of the fabricated restoration over their corresponding casts will be performed using cone beam CT just prior cementation of the restorations.
data will be collected and statistically analyzed.
Study Type
Interventional
Enrollment (Actual)
42
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 Locations
-
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Please Select...
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Cairo, Please Select..., Egypt, 11553
- Faculty of Dentistry, Cairo University
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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 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients with badly broken vital teeth young adult males or females (20-50 years) good oral hygeine cooperative patients approving to participate in the study
Exclusion Criteria:
- patients with acompromised medical history severe or active periodontal disease severe medical complications lack of compliance
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: nanohybrid composite blocks
nanohybrid composite CAD/CAM blocks
|
indirect restoration
|
|
Active Comparator: ceramic blocks
ceramic CAD/CAM blocks emax
|
indirect restoration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
internal fit evaluation
Time Frame: on cast before delivery
|
in millimeter
|
on cast before delivery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shereen H Ibrahim, PhD, associate professor of conservative Dentistry, faculty of dentistry Cairo university Egypt
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Actual)
April 1, 2019
Primary Completion (Actual)
April 5, 2020
Study Completion (Actual)
April 5, 2020
Study Registration Dates
First Submitted
March 3, 2021
First Submitted That Met QC Criteria
March 3, 2021
First Posted (Actual)
March 5, 2021
Study Record Updates
Last Update Posted (Actual)
March 5, 2021
Last Update Submitted That Met QC Criteria
March 3, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 8-3-19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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