Back to resultsEvaluation of the Antimicrobial Fiber Reinforced Composite Resin Space Maintainer Modified With Silver Nano Particles
Primary Purpose
Dental Caries in Children
Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Fiber reinforced composite resin space maintainer
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries in Children
Eligibility Criteria
Inclusion Criteria: Premature loss of primary molar. Presence of teeth on the mesial and distal sides of the extraction space. Normal primary molar relation. No root resorption of abutment teeth. Presence of a succedaneous tooth bud. Absence of pathology on the eruption track of the succedaneous tooth. The age will be ranged from 4 to 9 years. Exclusion Criteria: Carious buccal and lingual surface of abutment teeth. Absence of teeth on the mesial and distal sides of the extraction.
Sites / Locations
- Alazhar university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Fiber reinforced composite space maintainer
Fiber reinforced space maintainer with silver nano particles
Arm Description
12 children received fiber reinforced composite (FRC) space maintainer without silver nanoparticle.
12 children received fiber reinforced composite (FRC) space maintainers modified with silver nanoparticles.
Outcomes
Primary Outcome Measures
Evaluation of strepetoccous mutant and lactobacilli from sample of saliva
Streptococcus mutants : One loop (1/1000th ml of sample) was inoculated on the Mitis Salivarius (MSA)* agar with 0.2 U/ml bacitracin and sucrose (15% w/v) bacitracin. The plates were incubated aerobically ( 5% CO2) at 37°C for 48 h.(10) For determination of S. mutans count: After 48 h , colony characteristics were studied and the number of colony forming units of SM (CFU/ml) in saliva was determined manually .
Lactobacilli : One loop (1/1000th ml of sample) was inoculated on the Rogosa **SL agar plate. The plates were incubated aerobically ( 5% CO2) at 37°C for 48 h.(11) For determination of lactobacilli count: After 48 h , colony characteristics were studied and the number of colony forming units of lactobacilli (CFU/ml) in saliva was determined manually
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05902975
Brief Title
Evaluation of the Antimicrobial Fiber Reinforced Composite Resin Space Maintainer Modified With Silver Nano Particles
Official Title
Evaluation of the Antimicrobial Fiber Reinforced Composite Resin Space Maintainer Modified With Silver Nano Particles
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 21, 2022 (Actual)
Primary Completion Date
May 15, 2023 (Actual)
Study Completion Date
July 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Fiber reinforced composite resin space maintainer
Detailed Description
Evaluation of the antimicrobial fiber reinforced composite resin space maintainer modified by silver nano particles.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries in Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fiber reinforced composite space maintainer
Arm Type
Experimental
Arm Description
12 children received fiber reinforced composite (FRC) space maintainer without silver nanoparticle.
Arm Title
Fiber reinforced space maintainer with silver nano particles
Arm Type
Experimental
Arm Description
12 children received fiber reinforced composite (FRC) space maintainers modified with silver nanoparticles.
Intervention Type
Device
Intervention Name(s)
Fiber reinforced composite resin space maintainer
Intervention Description
Bonding of fiber reinforced with composite resin on primary second molar and primary canine under rubber dam isolation
Primary Outcome Measure Information:
Title
Evaluation of strepetoccous mutant and lactobacilli from sample of saliva
Description
Streptococcus mutants : One loop (1/1000th ml of sample) was inoculated on the Mitis Salivarius (MSA)* agar with 0.2 U/ml bacitracin and sucrose (15% w/v) bacitracin. The plates were incubated aerobically ( 5% CO2) at 37°C for 48 h.(10) For determination of S. mutans count: After 48 h , colony characteristics were studied and the number of colony forming units of SM (CFU/ml) in saliva was determined manually .
Lactobacilli : One loop (1/1000th ml of sample) was inoculated on the Rogosa **SL agar plate. The plates were incubated aerobically ( 5% CO2) at 37°C for 48 h.(11) For determination of lactobacilli count: After 48 h , colony characteristics were studied and the number of colony forming units of lactobacilli (CFU/ml) in saliva was determined manually
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Premature loss of primary molar.
Presence of teeth on the mesial and distal sides of the extraction space.
Normal primary molar relation.
No root resorption of abutment teeth.
Presence of a succedaneous tooth bud.
Absence of pathology on the eruption track of the succedaneous tooth.
The age will be ranged from 4 to 9 years.
Exclusion Criteria:
Carious buccal and lingual surface of abutment teeth.
Absence of teeth on the mesial and distal sides of the extraction.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alaa eldin Mahmoud Abdallah
Organizational Affiliation
Associate professior
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hamdy Mahmoud Badereldin
Organizational Affiliation
Lecture
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmed Akram Elawady
Organizational Affiliation
Lecture
Official's Role
Study Director
Facility Information:
Facility Name
Alazhar university
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Antimicrobial Fiber Reinforced Composite Resin Space Maintainer Modified With Silver Nano Particles
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