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

Dental Caries in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05902975
• Other study ID #: Space maintainer
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 21, 2022
• Est. completion date: July 15, 2023

Study information

• Verified date: June 2023
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Fiber reinforced composite resin space maintainer

Description:

Evaluation of the antimicrobial fiber reinforced composite resin space maintainer modified by silver nano particles.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: July 15, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

Device:
• Fiber reinforced composite resin space maintainer
Bonding of fiber reinforced with composite resin on primary second molar and primary canine under rubber dam isolation

Locations

Country	Name	City	State
Egypt	Alazhar university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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