- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04144062
Primary Molars Restoration Using CAD/CAM Crowns.
February 24, 2021 updated by: Ahmad Elheeny
CAD/CAM Crowns Versus Prefabricated Zirconia Crowns for Restoration of Primary Molars: A Prospective Study.
study aims to compare hybrid ceramic CAD/CAM and prefabricated zirconia crowns restoring primary molars through In-vivo evaluation of the clinical outcomes in terms of; treatment failure, amount of tooth wear in the opposing tooth and gingival health
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
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
-
-
-
Minya, Egypt, 61111
- Ahmad Elheeny
-
-
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
4 years to 7 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age range of the patients from 4 to 7 years old.
- Have no history of spontaneous pain or swelling.
- Patients willing to return for follow-up examinations and evaluation.
- Medically free patients or with controlled systemic disease ASA I or II.
- No active periodontal diseases.
- Patients with posterior pulpotomized tooth/teeth indicated for crown restoration (e.g. 2-3mm of teeth above cement-enamel junction).
Exclusion Criteria:
- Age range of the patients from 4 to 7 years old.
- Have no history of spontaneous pain or swelling.
- Patients willing to return for follow-up examinations and evaluation.
- Medically free patients or with controlled systemic disease ASA I or II.
- No active periodontal diseases.
- Patients with posterior pulpotomized tooth/teeth indicated for crown restoration (e.g. 2-3mm of teeth above cement-enamel junction).
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: Other
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Zirconia crowns
|
CAD/CAM crowns
|
Active Comparator: CAD/CAM crowns
|
CAD/CAM crowns
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
clinical success
Time Frame: 1 year
|
United States Public Health Service (USPHS) index
|
1 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 (Actual)
November 25, 2019
Primary Completion (Actual)
February 20, 2021
Study Completion (Actual)
February 20, 2021
Study Registration Dates
First Submitted
October 28, 2019
First Submitted That Met QC Criteria
October 28, 2019
First Posted (Actual)
October 30, 2019
Study Record Updates
Last Update Posted (Actual)
February 25, 2021
Last Update Submitted That Met QC Criteria
February 24, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 318
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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