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Clinical Trials/NCT05902975
NCT05902975UnknownNot Applicable

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

Al-Azhar University1 site in 1 country24 target enrollmentStarted: May 21, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
24
Locations
1
Primary Endpoint
Evaluation of strepetoccous mutant and lactobacilli from sample of saliva

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
4 Years to 9 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Fiber reinforced composite space maintainer

Experimental

12 children received fiber reinforced composite (FRC) space maintainer without silver nanoparticle.

Intervention: Fiber reinforced composite resin space maintainer (Device)

Fiber reinforced space maintainer with silver nano particles

Experimental

12 children received fiber reinforced composite (FRC) space maintainers modified with silver nanoparticles.

Intervention: Fiber reinforced composite resin space maintainer (Device)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohamed Nada Mohamed Elsadany

Mohamed nada Mohamed elsadany

Al-Azhar University

Study Sites (1)

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