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Recruiting 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

No phase Interventional Probiotic Ethyl Lauroyl Arginate Mouthwashes Streptococcus Mutans

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Probiotic mouthwash, Ethyl lauroyl arginate mouthwash, Professional prophylaxis (scaling + polishing).
Who it may be relevant to
Registry conditions: Probiotic, Ethyl Lauroyl Arginate, Mouthwashes, Streptococcus Mutans. Basic parameters: 6 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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

  • Other Probiotic mouthwash
    Patients will be receive probiotic 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.
  • 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.

Primary outcome measures

  • S. mutans count [Time frame: 28 days post-intervention]
Secondary outcome measures (2)
  • Plaque index score [Time frame: 28 days post-intervention]
  • Salivary pH [Time frame: 28 days post-intervention]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Al-Azhar University (Faculty of Dentistry) — Cairo

Identifiers

NCT: NCT07356869 · 1246/4697

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗