Evaluation of the Antimicrobial Fiber Reinforced Composite Resin Space Maintainer Modified With Silver Nano Particles

Not Applicable

Active, not recruiting

• Conditions: Dental Caries in Children
• Interventions: Device: Fiber reinforced composite resin space maintainer

• Registration Number: NCT05902975
• Lead Sponsor: Al-Azhar University

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.

Study Timeline

• Study Start: 2022-05-21
• Primary Completion: 2023-05-15
• Study First Submitted: 2023-05-21
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-13
• Last Update Submitted: 2023-06-13
• Study First Posted: 2023-06-15
• Last Update Posted: 2023-06-15
• Study Completion: 2023-07-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fiber reinforced composite space maintainer	Fiber reinforced composite resin space maintainer	12 children received fiber reinforced composite (FRC) space maintainer without silver nanoparticle.
Fiber reinforced space maintainer with silver nano particles	Fiber reinforced composite resin space maintainer	12 children received fiber reinforced composite (FRC) space maintainers modified with silver nanoparticles.

Primary Outcome Measures

Name	Time	Method
Evaluation of strepetoccous mutant and lactobacilli from sample of saliva	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

Trial Locations

Locations (1)

Alazhar university; 🇪🇬 Cairo, Egypt