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

NCT ID: NCT06834815

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-05
• Study Completion Date: 2025-03-01

Brief Summary

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.

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.

Conditions

Black Stains

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Probiotic with Prebiotic

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

faculty of dentistry .Ain shams university

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FDASU-Rec IR102420

Identifier Type: -

Identifier Source: org_study_id