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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05902975
Other study ID # Space maintainer
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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