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

June 13, 2023 updated by: Mohamed Nada Mohamed Elsadany, Al-Azhar University
Fiber reinforced composite resin space maintainer

Study Overview

Status

Active, not recruiting

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt
        • Alazhar University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fiber reinforced composite space maintainer
12 children received fiber reinforced composite (FRC) space maintainer without silver nanoparticle.
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.
Bonding of fiber reinforced with composite resin on primary second molar and primary canine under rubber dam isolation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2022

Primary Completion (Actual)

May 15, 2023

Study Completion (Estimated)

July 15, 2023

Study Registration Dates

First Submitted

May 21, 2023

First Submitted That Met QC Criteria

June 13, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Space maintainer

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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