Investigating the Bactericidal Effect of Probiotics on Chromogenic Bacteria in Children An In Vivo and In Vitro Study

Effect of Probiotics on Chromogenic Bacteria and Extrinsic Stains in Children

To investigate the bactericidal effect of probiotics (Streptococcus salivarius M18 and Lactobacillus reuteri) on two types of bacteria (Aggregatibacter actinomycetemcomitans and Actinomyces naeslundii) causing black stains of teeth in vitro.

Study Overview

• Status: Completed
• Conditions: Black Stains
• Intervention / Treatment: Drug: Probiotic with Prebiotic

Detailed Description

In vitro:

An unstimulated salivary sample will be taken from patients having black stains. The two types of bacteria of each condition will be cultured, amplified, and measured in the laboratory from the saliva of these patients. After that, one type of probiotics will be applied to these bacteria separately and the same bacterial measurement will be done to evaluate the bactericidal effect of the probiotics on these bacteria, aiming to find the minimal inhibitory concentration of the probiotics.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11566
    • faculty of dentistry .Ain shams university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients with black stains on teeth scored via modified Lobene index scores 1-3.
• Medically free patients

Exclusion Criteria:

• Stains other than black.
• Patients on antibiotic treatment or any other medication for the last 2 weeks.
• Patients allergic to prophylaxis powder.
• Parents refusing to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: before and after probiotic administration; all patients will submit an unstimulated salivary sample of 1ml will in sealed test tube; then the patients will receive probiotics for 14 days .; after 14 days and another salivary sample will be collected

Drug: Probiotic with Prebiotic; After assigning the patients , all patients will submit an unstimulated salivary sample of 1ml will in sealed test tubes then stored in a deep freezer until microbiological evaluation, then they'll receive an oral prophylaxis session.; The patients will receive probiotics for 14 days given to them in a sealed box.; All patients will be followed up after 14 days and another salivary sample will be collected and sent for microbiological assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
chromogenic bacterial count before and after probiotic application	bacterial count	two weeks

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2024
• Primary Completion (Actual): February 20, 2025
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: February 14, 2025
• First Submitted That Met QC Criteria: February 14, 2025
• First Posted (Actual): February 19, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 13, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: probiotics; black stains; chromogenic bacteria
• Other Study ID Numbers: FDASU-Rec IR102420

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No