ProbioticNCT07356869
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 study testing Probiotic mouthwash, Ethyl lauroyl arginate mouthwash and Professional prophylaxis (scaling + polishing) in people with Probiotic and Ethyl Lauroyl Arginate, run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Probiotic, Ethyl Lauroyl Arginate, Mouthwashes
- What is being tested?
- Probiotic mouthwash, Ethyl lauroyl arginate mouthwash and Professional prophylaxis (scaling + polishing)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy Egyptian schoolchildren aged 6-12 years.
- Good general health.
- Mild to moderate dental plaque accumulation.
- Parental/caregiver willingness to provide consent
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Al-Azhar University (Faculty of Dentistry)
Cairo, 11651
Mohamed O Abdelrazik, MBBCH, 00201017005990, mohamedghitany96@gmail.com
Adel F Hussein, MD
About this study
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
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.
Read the 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.
- Conditions
- Probiotic, Ethyl Lauroyl Arginate, Mouthwashes, Streptococcus Mutans, Dental Plaque, Salivary pH
- Being tested
- Probiotic mouthwash, Ethyl lauroyl arginate mouthwash, Professional prophylaxis (scaling + polishing)
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic mouthwashOther
Patients will be receive probiotic mouthwash and instructed to rinse 5ml twice daily for 30 seconds for 28 days.
Ethyl lauroyl arginate mouthwashOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients will be receive probiotic mouthwash and instructed to rinse 5ml twice daily for 30 seconds for 28 days. Receives: 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. Receives: 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. Receives: Other: Professional prophylaxis (scaling + polishing) |
What is being measured
The primary outcome is the main question the study is designed to answer.
S. mutans count
- mutans count will be measured at baseline (0 day) and post-intervention (28 days).
Measured: 28 days post-intervention
Secondary outcomes (2)
Plaque index score
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).
Measured: 28 days post-intervention
Salivary pH
Salivary pH measurements will be carried out by pH strips or pH meter.
Measured: 28 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start15 Aug 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProbioticStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Osama Mohamed Abdelrazik, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356869
- Sponsor's protocol ID
- 1246/4697
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07356869
- Acronym / sponsor ID
- 1246/4697
- Conditions
- Probiotic, Ethyl Lauroyl Arginate, Mouthwashes, Streptococcus Mutans, Dental Plaque, Salivary pH
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Probiotic mouthwashPatients will be receive probiotic mouthwash and instructed to rinse 5ml twice daily for 30 seconds for 28 days. |
| Group B | Experimental | Other: Ethyl lauroyl arginate mouthwashPatients will be treated with ethyl lauroyl arginate-containing mouthwash and instructed to rinse 5ml twice daily for 30 seconds for 28 days. |
| Group C | Active comparator | 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy Egyptian schoolchildren aged 6-12 years.
- Good general health.
- Mild to moderate dental plaque accumulation.
- Parental/caregiver willingness to provide consent
Key exclusion criteria (4 listed)
- Antibiotic or antimicrobial use within the last month.
- Allergies to the mouthwash components.
- Systemic diseases affecting oral health.
- Orthodontic appliances or extensive dental restorations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic mouthwashPatients will be receive probiotic mouthwash and instructed to rinse 5ml twice daily for 30 seconds for 28 days. | Other | Group A |
| Ethyl lauroyl arginate mouthwashPatients will be treated with ethyl lauroyl arginate mouthwash and instructed to rinse 5ml twice daily for 30 seconds for 28 days. | Other | Group B |
| 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. | Other | Group C |
Primary outcome
S. mutans count
Time frame: 28 days post-intervention
S. mutans count will be measured at baseline (0 day) and post-intervention (28 days).
2 secondary outcomes
Plaque index score
Time frame: 28 days post-intervention
Salivary pH
Time frame: 28 days post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic mouthwash, Ethyl lauroyl arginate mouthwash and Professional prophylaxis (scaling + polishing) in people with Probiotic and Ethyl Lauroyl Arginate, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed O Abdelrazik, MBBCH (00201017005990, mohamedghitany96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
S. mutans count (time frame: 28 days post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.