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Completed

NCT Number: NCT06834815

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

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.

Completed

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Key information

Conditions

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

faculty of dentistry .Ain shams university

Cairo, 11566, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic with Prebiotic

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.

Primary outcomes

  1. chromogenic bacterial count before and after probiotic application

    Time frame: two weeks

    bacterial count

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Effect of Probiotics on Chromogenic Bacteria and Extrinsic Stains in Children

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 19, 2025
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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