Probiotic-Based Versus Ethyl Lauroyl Arginate-Containing Mouthwashes on Streptococcus Mutans Counts, Dental Plaque Accumulation, and Salivary pH in a Group of Egyptian School Children

January 13, 2026 updated by: Mohamed Osama Mohamed Abdelrazik, Al-Azhar University

Comparative Evaluation of Probiotic-Based Versus Ethyl Lauroyl Arginate-Containing Mouthwashes on Streptococcus Mutans Counts, Dental Plaque Accumulation, and Salivary pH in a Group of Egyptian School Children: A Randomized Controlled Clinical Trial

This study aims to compare the efficacy of probiotic-based mouthwashes versus ethyl lauroyl arginate-containing mouthwashes in reducing Streptococcus mutans count, dental plaque accumulation, and salivary pH among a group of Egyptian schoolchildren.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Dental caries remains one of the most prevalent chronic infectious diseases among Egyptian schoolchildren, with Streptococcus mutans (S. mutans) playing a primary etiological role due to its acidogenic and aciduric properties, which contribute to enamel demineralization and plaque formation.

Ethyl Lauroyl Arginate (LAE), a cationic surfactant derived from lauric acid and arginine, has demonstrated potent bactericidal activity against cariogenic organisms, including S. mutans, while also reducing biofilm formation and preserving oral microbiome balance.

Study Type

Interventional

Enrollment (Estimated)

66

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 Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 11651
        • Recruiting
        • Al-Azhar University (Faculty of Dentistry)
        • Contact:
        • Sub-Investigator:
          • Adel F Hussein, MD
        • Sub-Investigator:
          • Ramy S Khairallah, MD
        • Sub-Investigator:
          • Alsayed E Mekky, MD

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

No

Description

Inclusion Criteria:

  • Healthy Egyptian schoolchildren aged 6-12 years.
  • Good general health.
  • Mild to moderate dental plaque accumulation.
  • Parental/caregiver willingness to provide consent

Exclusion Criteria:

  • Antibiotic or antimicrobial use within the last month.
  • Allergies to the mouthwash components.
  • Systemic diseases affecting oral health.
  • Orthodontic appliances or extensive dental restorations.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Patients will be receive probiotic mouthwash and instructed to rinse 5ml twice daily for 30 seconds for 28 days.
Other: Probiotic mouthwash
Patients will be receive probiotic mouthwash and instructed to rinse 5ml twice daily for 30 seconds for 28 days.
Experimental: Group B
Patients will be treated with ethyl lauroyl arginate-containing mouthwash and instructed to rinse 5ml twice daily for 30 seconds for 28 days.
Other: Ethyl lauroyl arginate mouthwash
Patients will be treated with ethyl lauroyl arginate mouthwash and instructed to rinse 5ml twice daily for 30 seconds for 28 days.
Active Comparator: Group C
Patients will receive professional prophylaxis (scaling + polishing) at baseline and will use only regular toothpaste twice daily, with no adjunctive mouthwashes over 28 days.
Other: Professional prophylaxis (scaling + polishing)
Patients will receive professional prophylaxis (scaling + polishing) at baseline and will use only regular toothpaste twice daily, with no adjunctive mouthwashes over 28 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
S. mutans count
Time Frame: 28 days post-intervention
S. mutans count will be measured at baseline (0 day) and post-intervention (28 days).
28 days post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque index score
Time Frame: 28 days post-intervention

The plaque index score is classified as:

  • Score 0; No plaque
  • Score 1; Mild plaque accumulated along the gingival margin
  • Score 2; Moderate plaques accumulated along the gingival margin
  • Score 3; Heavy plaques accumulated along the gingival margin and adjacent tooth surface.

Plaque index score will be measured at baseline (0 day) and post-intervention (28 days).
28 days post-intervention
Salivary pH
Time Frame: 28 days post-intervention
Salivary pH measurements will be carried out by pH strips or pH meter.
28 days post-intervention

Collaborators and Investigators

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

Sponsor

Al-Azhar University

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)

August 15, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

January 13, 2026

First Submitted That Met QC Criteria

January 13, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1246/4697

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of study for one year.

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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