Black StainsPhase 4NCT06834815
Investigating the Bactericidal Effect of Probiotics on Chromogenic Bacteria in Children An In Vivo and In Vitro Study
A Phase 4 study testing Probiotic with Prebiotic in people with Black Stains, run by Ain Shams University at 1 site in Egypt.
Trial summary
To investigate the bactericidal effect of probiotics (Streptococcus salivarius M18 and Lactobacillus reuteri) on two types of bacteria (Aggregatibacter actinomycetemcomitans and Actinomyces naeslundii) causing black stains of teeth in vitro. Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Black Stains
- What is being tested?
- Probiotic with Prebiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Nov 2024to 1 Mar 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients with black stains on teeth scored via modified Lobene index scores 1-3.
- Medically free patients
Who cannot join
- Stains other than black.
- Patients on antibiotic treatment or any other medication for the last 2 weeks.
- Patients allergic to prophylaxis powder.
- Parents refusing to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Probiotics on Chromogenic Bacteria and Extrinsic Stains in Children
To investigate the bactericidal effect of probiotics (Streptococcus salivarius M18 and Lactobacillus reuteri) on two types of bacteria (Aggregatibacter actinomycetemcomitans and Actinomyces naeslundii) causing black stains of teeth in vitro.
Read the detailed description
In vitro:
An unstimulated salivary sample will be taken from patients having black stains. The two types of bacteria of each condition will be cultured, amplified, and measured in the laboratory from the saliva of these patients. After that, one type of probiotics will be applied to these bacteria separately and the same bacterial measurement will be done to evaluate the bactericidal effect of the probiotics on these bacteria, aiming to find the minimal inhibitory concentration of the probiotics.
- Conditions
- Black Stains
- Being tested
- Probiotic with Prebiotic
- Keywords
- probiotics, chromogenic bacteria, black stains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic with PrebioticDrug
After assigning the patients , all patients will submit an unstimulated salivary sample of 1ml will in sealed test tubes then stored in a deep freezer until microbiological evaluation, then they'll receive an oral prophylaxis session.
- The patients will receive probiotics for 14 days given to them in a sealed box.
- All patients will be followed up after 14 days and another salivary sample will be collected and sent for microbiological assessment.
| Study group | Role | What they receive |
|---|---|---|
| before and after probiotic administration | Experimental | all patients will submit an unstimulated salivary sample of 1ml will in sealed test tube
* then the patients will receive probiotics for 14 days .
* after 14 days and another salivary sample will be collected Receives: Drug: Probiotic with Prebiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
chromogenic bacterial count before and after probiotic application
bacterial count
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start5 Nov 2024
- Primary completion20 Feb 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Black StainsStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- probiotics
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834815
- Sponsor's protocol ID
- FDASU-Rec IR102420
- Status last verified
- Nov 2024
- First submitted
- 14 Feb 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotics on Chromogenic Bacteria and Extrinsic Stains in Children
- ClinicalTrials.gov ID
- NCT06834815
- Acronym / sponsor ID
- FDASU-Rec IR102420
- Conditions
- Black Stains
- Keywords
- probiotics, chromogenic bacteria, black stains
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 19 Feb 2025 (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.
To investigate the bactericidal effect of probiotics (Streptococcus salivarius M18 and Lactobacillus reuteri) on two types of bacteria (Aggregatibacter actinomycetemcomitans and Actinomyces naeslundii) causing black stains of teeth in vitro.
Detailed description
In vitro:
An unstimulated salivary sample will be taken from patients having black stains. The two types of bacteria of each condition will be cultured, amplified, and measured in the laboratory from the saliva of these patients. After that, one type of probiotics will be applied to these bacteria separately and the same bacterial measurement will be done to evaluate the bactericidal effect of the probiotics on these bacteria, aiming to find the minimal inhibitory concentration of the probiotics.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- probiotics
| Arm | Type | Receives |
|---|---|---|
| before and after probiotic administration | Experimental | Drug: Probiotic with Prebioticall patients will submit an unstimulated salivary sample of 1ml will in sealed test tube * then the patients will receive probiotics for 14 days . * after 14 days and another salivary sample will be collected |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients with black stains on teeth scored via modified Lobene index scores 1-3.
- Medically free patients
Key exclusion criteria (4 listed)
- Stains other than black.
- Patients on antibiotic treatment or any other medication for the last 2 weeks.
- Patients allergic to prophylaxis powder.
- Parents refusing to participate
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 with PrebioticAfter assigning the patients , all patients will submit an unstimulated salivary sample of 1ml will in sealed test tubes then stored in a deep freezer until microbiological evaluation, then they'll receive an oral prophylaxis session. * The patients will receive probiotics for 14 days given to them in a sealed box. * All patients will be followed up after 14 days and another salivary sample will be collected and sent for microbiological assessment. | Drug | before and after probiotic administration |
Primary outcome
chromogenic bacterial count before and after probiotic application
Time frame: two weeks
bacterial count
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Probiotic with Prebiotic in people with Black Stains, run by Ain Shams 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 2 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: finished, as of the sponsor's last update on 16 Apr 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
chromogenic bacterial count before and after probiotic application (time frame: two weeks). 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 16 Apr 2025.