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NCT Number: NCT07356869

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

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.

Recruiting

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Azhar University (Faculty of Dentistry)

Cairo, 11651, Egypt

Location status: Recruiting

Location contact

Adel F Hussein, MD

SUB_INVESTIGATOR

Alsayed E Mekky, MD

SUB_INVESTIGATOR

Mohamed O Abdelrazik, MBBCH

CONTACT

[email protected]

00201017005990

Ramy S Khairallah, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic mouthwash

Other

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

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.

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.

Primary outcomes

  1. S. mutans count

    Time frame: 28 days post-intervention

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

Secondary outcomes

  1. 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).

  2. Salivary pH

    Time frame: 28 days post-intervention

    Salivary pH measurements will be carried out by pH strips or pH meter.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed O Abdelrazik, MBBCH

CONTACT

[email protected]

00201017005990

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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