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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07356869

Enrollment

Registered

2026-01-21

Start date

2025-08-15

Completion date

2026-09-01

Last updated

2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

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.

Interventions

OTHERProbiotic mouthwash

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

OTHEREthyl 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.

OTHERProfessional 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to 12 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Plaque index score	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).
Salivary pH	28 days post-intervention	Salivary pH measurements will be carried out by pH strips or pH meter.

Countries

Egypt

Contacts

CONTACTMohamed O Abdelrazik, MBBCH

mohamedghitany96@gmail.com00201017005990

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026