- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04973761
Quality of Life for Children With Zirconium Anteroir Crowns Versus Strip Composite Crowns
August 2, 2021 updated by: Mahmoud Ahmed Mahmoud, Minia University
Evaliation of Oral Health Quality of Life for Children With Zirconium Crowns Versus Anteroir Strip Composite Crowns After 6 and 12 Months
Early Childhood Oral Health Impact Scale (ECOHIS) will be used for detection of oral health related quality of life for children using strip composite crowns versus zirconium crowns at 6 and 12 months
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
136
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
- Minia University
-
-
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:
- healthy children Cariuos primary anteroir teeth Cooperative children
Exclusion Criteria:
- children with systemic diseases Children with bad oral habits
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Strip composite crowns
|
Strip composite crowns
|
|
Experimental: Zirconium crowns
|
Prefabricated pirmary anteroir teeth zirconium crowns
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oral health related quality of life
Time Frame: 12 months
|
Early Childhood Oral Health Impact Scale (ECOHIS).
|
12 months
|
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)
March 1, 2018
Primary Completion (Actual)
November 1, 2020
Study Completion (Actual)
January 1, 2021
Study Registration Dates
First Submitted
July 17, 2021
First Submitted That Met QC Criteria
July 21, 2021
First Posted (Actual)
July 22, 2021
Study Record Updates
Last Update Posted (Actual)
August 3, 2021
Last Update Submitted That Met QC Criteria
August 2, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 401 (Other Identifier: AGORA HCL)
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.