Back to resultsthe Antibacterial Effect of Zinc ,Silver and Fluoride
Primary Purpose
Dental Caries
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
silver modified glass ionomer
zinc modified
conventional glass ionomer
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries
Eligibility Criteria
Inclusion Criteria:
- patient need teeth extraction for orthodontic treatment
Exclusion Criteria:
- carious teeth deciduous teeth
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
conventional glass ionomer
zinc modified glass ionomer
silver modified glass ionomer
Arm Description
Outcomes
Primary Outcome Measures
bacterial count
streptococcus mutant count by culture of dentin sample excavated from the tooth after restoration removal
elementary analysis of dentin
elementary analysis of dentin component excavated from the cavity after restoration removal to detect the change in tooth mineral
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04329858
Brief Title
the Antibacterial Effect of Zinc ,Silver and Fluoride
Official Title
the Antibacterial Effect of Different Glass Ionomer Restoration Containing Zinc ,Silver and Fluoride Ion:in Situ Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2021 (Anticipated)
Primary Completion Date
July 15, 2021 (Anticipated)
Study Completion Date
July 15, 2021 (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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
natural teeth will be filled with the 3 different material then the dentin sample will be collected ,bacterial culture and elementary analysis will be done
Detailed Description
orthodontic patient with premolar indicated for extraction , teeth will restored with the different material 3 months before doing extraction
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
conventional glass ionomer
Arm Type
Active Comparator
Arm Title
zinc modified glass ionomer
Arm Type
Experimental
Arm Title
silver modified glass ionomer
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
silver modified glass ionomer
Intervention Description
occlusal cavity filled with silver modified
Intervention Type
Procedure
Intervention Name(s)
zinc modified
Intervention Description
occlusal cavity filled with zinc modified
Intervention Type
Procedure
Intervention Name(s)
conventional glass ionomer
Intervention Description
occlusal cavity filled with conventional glass ionomer
Primary Outcome Measure Information:
Title
bacterial count
Description
streptococcus mutant count by culture of dentin sample excavated from the tooth after restoration removal
Time Frame
3months
Title
elementary analysis of dentin
Description
elementary analysis of dentin component excavated from the cavity after restoration removal to detect the change in tooth mineral
Time Frame
3months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patient need teeth extraction for orthodontic treatment
Exclusion Criteria:
carious teeth deciduous teeth
12. IPD Sharing Statement
Learn more about this trial
the Antibacterial Effect of Zinc ,Silver and Fluoride
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