- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05902975
Evaluation of the Antimicrobial Fiber Reinforced Composite Resin Space Maintainer Modified With Silver Nano Particles
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- Alazhar University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
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 |
|---|---|
|
Experimental: Fiber reinforced composite space maintainer
12 children received fiber reinforced composite (FRC) space maintainer without silver nanoparticle.
|
Bonding of fiber reinforced with composite resin on primary second molar and primary canine under rubber dam isolation
|
|
Experimental: Fiber reinforced space maintainer with silver nano particles
12 children received fiber reinforced composite (FRC) space maintainers modified with silver nanoparticles.
|
Bonding of fiber reinforced with composite resin on primary second molar and primary canine under rubber dam isolation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of strepetoccous mutant and lactobacilli from sample of saliva
Time Frame: 6 month
|
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 |
6 month
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Alaa eldin Mahmoud Abdallah, Associate professior
- Study Director: Hamdy Mahmoud Badereldin, lecture
- Study Director: Ahmed Akram Elawady, lecture
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Space maintainer
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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