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

NCT05902975 | Unknown

• 1 other identifier: Space maintainer
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Fiber reinforced composite resin space maintainer

Conditions

Dental Caries in Children

Outcome Measures

Primary Outcomes (1)

• 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

  6 month

Study Arms (2)

Fiber reinforced composite space maintainer

EXPERIMENTAL

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

Device: Fiber reinforced composite resin space maintainer

Fiber reinforced space maintainer with silver nano particles

EXPERIMENTAL

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

Device: Fiber reinforced composite resin space maintainer

Interventions

Fiber reinforced composite resin space maintainer DEVICE

Bonding of fiber reinforced with composite resin on primary second molar and primary canine under rubber dam isolation

Fiber reinforced composite space maintainer; Fiber reinforced space maintainer with silver nano particles

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Carious buccal and lingual surface of abutment teeth.
• Absence of teeth on the mesial and distal sides of the extraction.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Alazhar university

Cairo, Egypt

Location

Study Officials

• Alaa eldin Mahmoud Abdallah

  Associate professior

  STUDY DIRECTOR

• Hamdy Mahmoud Badereldin

  Lecture

  STUDY DIRECTOR

• Ahmed Akram Elawady

  Lecture

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mohamed nada Mohamed elsadany

Study Record Dates

• First Submitted: May 21, 2023
• First Posted: June 15, 2023
• Study Start: May 21, 2022
• Primary Completion: May 15, 2023
• Study Completion: July 15, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

EG (1)