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

Al-Azhar University

Status: Enrolling

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

Treatments: Other: Ethyl lauroyl arginate mouthwash; Other: Professional prophylaxis (scaling + polishing); Other: Probiotic mouthwash

Study type: Interventional

Funder types: Other

Identifiers

NCT07356869

1246/4697

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 3 patient groups

Group A

Experimental group

Description:

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

Treatment:

Other: Probiotic mouthwash

Group B

Experimental group

Description:

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

Treatment:

Other: Ethyl lauroyl arginate mouthwash

Group C

Active Comparator group

Description:

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

Treatment:

Other: Professional prophylaxis (scaling + polishing)