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

Sponsor

Al-Azhar University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05902975

Collaborator

(none)

Enrollment

Location

Arms

13.8

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Fiber reinforced composite resin space maintainer

Condition or Disease	Intervention/Treatment	Phase
Dental Caries in Children	Device: Fiber reinforced composite resin space maintainer	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 21, 2022

Actual Primary Completion Date :

May 15, 2023

Anticipated Study Completion Date :

Jul 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fiber reinforced composite space maintainer 12 children received fiber reinforced composite (FRC) space maintainer without silver nanoparticle.	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
Experimental: Fiber reinforced space maintainer with silver nano particles 12 children received fiber reinforced composite (FRC) space maintainers modified with silver nanoparticles.	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

Arm

Intervention/Treatment

Experimental: Fiber reinforced composite space maintainer

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

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

Experimental: Fiber reinforced space maintainer with silver nano particles

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 9 Years

Sexes Eligible for Study:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alazhar university	Cairo		Egypt

Sponsors and Collaborators

Al-Azhar University

Investigators

Study Director: Alaa eldin Mahmoud Abdallah, Associate professior
Study Director: Hamdy Mahmoud Badereldin, Lecture
Study Director: Ahmed Akram Elawady, Lecture

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Nada Mohamed Elsadany, Mohamed nada Mohamed elsadany, Al-Azhar University

ClinicalTrials.gov Identifier:

NCT05902975

Other Study ID Numbers:

Space maintainer

First Posted:

Jun 15, 2023

Last Update Posted:

Jun 15, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dental Caries

Study Results

No Results Posted as of Jun 15, 2023