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

NCT07356869 | Recruiting

• 1 other identifier: 1246/4697
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Probiotic; Ethyl Lauroyl Arginate; Mouthwashes; Streptococcus Mutans; Dental Plaque; Salivary pH; Children

Outcome Measures

Primary Outcomes (1)

• S. mutans count

  S. mutans count will be measured at baseline (0 day) and post-intervention (28 days).

  28 days post-intervention

Secondary Outcomes (2)

• Plaque index score

  28 days post-intervention

• Salivary pH

  28 days post-intervention

Study Arms (3)

Group A

EXPERIMENTAL

Patients will be receive probiotic mouthwash and instructed to rinse 5ml twice daily for 30 seconds for 28 days.

Other: Probiotic mouthwash

Group B

EXPERIMENTAL

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

Group C

ACTIVE COMPARATOR

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)

Interventions

Probiotic mouthwash OTHER

Patients will be receive probiotic mouthwash and instructed to rinse 5ml twice daily for 30 seconds for 28 days.

Group A

Ethyl lauroyl arginate mouthwash OTHER

Patients will be treated with ethyl lauroyl arginate mouthwash and instructed to rinse 5ml twice daily for 30 seconds for 28 days.

Group B

Professional prophylaxis (scaling + polishing) OTHER

Patients will receive professional prophylaxis (scaling + polishing) at baseline and will use only regular toothpaste twice daily, with no adjunctive mouthwashes over 28 days.

Group C

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar University (Faculty of Dentistry)

Cairo, 11651, Egypt

RECRUITING

MeSH Terms

Conditions

Dental Plaque

Interventions

Tooth Exfoliation

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Central Study Contacts

Mohamed O Abdelrazik, MBBCH

CONTACT

00201017005990; mohamedghitany96@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: B.D.S, Faculty of Dental Medicine (Cairo-Boys), Al-Azhar University

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 21, 2026
• Study Start: August 15, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)