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

NCT06834815 | Completed Phase 4

• 1 other identifier: FDASU-Rec IR102420
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Black Stains

Keywords

probiotics; chromogenic bacteria; black stains

Outcome Measures

Primary Outcomes (1)

• chromogenic bacterial count before and after probiotic application

  bacterial count

  two weeks

Study Arms (1)

before and after probiotic administration

EXPERIMENTAL

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

Interventions

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.

before and after probiotic administration

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

faculty of dentistry .Ain shams university

Cairo, 11566, Egypt

Location

MeSH Terms

Interventions

Probiotics; Prebiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: probiotics

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 19, 2025
• Study Start: November 5, 2024
• Primary Completion: February 20, 2025
• Study Completion: March 1, 2025
• Last Updated: April 16, 2025

Record last verified: 2024-11

Locations

EG (1)