Dental Caries in ChildrenNCT07904221
Evaluation of the Antibacterial Effect of Probiotics on Cariogenic Bacteria in Children
A study testing Probiotic lozenges containing Streptococcus salivarius, Lactobacillus reuteri, and Lactobacillus paracasei and Xylitol-based moisturizing lozenges in people with Dental Caries in Children, run by Ain Shams University at 1 site in Egypt.
Trial summary
This randomized controlled clinical trial aims to evaluate the effect of oral probiotic lozenges containing Streptococcus salivarius, Lactobacillus reuteri, and Lactobacillus paracasei on cariogenic bacteria (Streptococcus mutans, Lactobacillus acidophilus) , salivary pH, buffering capacity, and plaque accumulation in… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- Probiotic lozenges containing Streptococcus salivarius, Lactobacillus reuteri, and Lactobacillus paracasei and Xylitol-based moisturizing lozenges
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2026to 15 Oct 2026
- Phase
- Interventional
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 6-12-year-old children.
- High caries risk patient according to caries risk assessment (CAMBRA).
Who cannot join
- Patients or parents who refuse to participate.
- Children who have received antibiotics or corticosteroids in the previous 48 hours before being recruited.
- Children with mental and physical disabilities.
- Orphaned children.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Antibacterial Effect of Probiotics on Cariogenic Bacteria in Children : A Randomized Controlled Trial
This randomized controlled clinical trial aims to evaluate the effect of oral probiotic lozenges containing Streptococcus salivarius, Lactobacillus reuteri, and Lactobacillus paracasei on cariogenic bacteria (Streptococcus mutans, Lactobacillus acidophilus) , salivary pH, buffering capacity, and plaque accumulation in children aged 6-12 years at high caries risk. Sixty children will be assigned into three groups: probiotic, positive control (xylitol lozenges), and negative control (no lozenges). Salivary and plaque parameters will be assessed before and after a 4-week intervention period.
Read the detailed description
- Abstract
Statement of the problem:
Tooth decay is a common problem among children that significantly affects their oral health. Traditional preventive measures have achieved limited success. Therefore, this study aims to explore the potential of probiotic lozenges to improve oral health by reducing harmful bacteria and enhancing saliva properties, providing a new preventive approach.
The aim of this study is to:
- 1) Evaluate the antibacterial effect of oral probiotics lozenges containing Streptococcus salivarius, Lactobacillus reuteri, and Lactobacillus paracasei on the levels of cariogenic bacteria including Streptococcus mutans and Lactobacillus acidophilus in 6-12 year old children.
- Evaluate the effect of the same type of probiotics lozenges on the salivary pH and buffering capacity of the saliva in 6-12 year old children.
- Evaluate the effect of the same type of probiotics lozenges on plaque accumulation in 6-12 year old children.
Materials and methods:
- This is a single -blinded randomized controlled clinical trial that will involve children aged 6 to 12 years. Participants will be randomly selected, and their caries risk assessment (CAMBRA) will be evaluated for choosing 60 children with high caries risk.
- plaque accumulation will be measured using Oral Hygiene Index Simplified.
- Unstimulated pre-salivary samples will be collected.
- The salivary sample will be analyzed for the levels of Streptococcus mutans, Lactobacillus acidophilus, salivary pH, and buffering capacity.
- The children will be divided into three groups: an experimental group and two control groups. The experimental group will be provided with oral probiotic lozenges containing Streptococcus salivarius, Lactobacillus reuteri, and Lactobacillus paracasei for daily consumption once a day at home over a period of four weeks. The first control group will receive xylitol-based moisturizing lozenges as a positive control once a day, while the second control group will serve as a negative control, receiving no lozenges. All groups will be instructed to maintain standardized oral hygiene practices, and will be provided with fluoridated toothpaste and toothbrushes.
- After four weeks, plaque accumulation will be remeasured using Oral Hygiene Index Simplified.
- post-salivary samples will be collected and analyzed for the same parameters, including the levels of Streptococcus mutans, Lactobacillus acidophilus, salivary pH, and buffering capacity.
- Conditions
- Dental Caries in Children
- Being tested
- Probiotic lozenges containing Streptococcus salivarius, Lactobacillus reuteri, and Lactobacillus paracasei, Xylitol-based moisturizing lozenges
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic lozenges containing Streptococcus salivarius, Lactobacillus reuteri, and Lactobacillus paracaseiDietary supplement
Also called SUPERTEETH DENTAL PROBIOTIC
Participants in this group will receive oral probiotics lozenge for daily consumption for 28 days ,once a day (probiotic containing mainly Streptococcus salivarius, Lactobacillus reuteri, and Lactobacillus paracasei). Participants will be instructed to maintain standard oral hygiene practices using fluoridated toothpaste.
Xylitol-based moisturizing lozengesDietary supplement
Also called XyliDENT
Participants in this group will receive one xylitol-based moisturizing lozenge daily for four weeks. The lozenge is to be taken once a day at home. Participants will follow the same oral hygiene instructions as the other groups.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Lozenges Group | Experimental | Participants will receive oral probiotic lozenges containing Streptococcus salivarius, Lactobacillus reuteri, and Lactobacillus paracasei. Lozenges will be administered once daily at home for 4 weeks. Receives: Dietary Supplement: Probiotic lozenges containing Streptococcus salivarius, Lactobacillus reuteri, and Lactobacillus paracasei |
| Xylitol Lozenges Group | Active comparator | Participants will receive xylitol-based moisturizing lozenges once daily at home for 4 weeks. Receives: Dietary Supplement: Xylitol-based moisturizing lozenges |
| No Lozenges Group | No intervention | Participants will not receive any lozenges but will follow standardized oral hygiene practices during the 4-week period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary load of Streptococcus mutans
Change in salivary Streptococcus mutans load from baseline to 4 weeks after the intervention, measured using quantitative real-time polymerase chain reaction (qRT-PCR).
Measured: Baseline and 4 weeks after intervention
Salivary load of Lactobacillus acidophilus
Change in salivary Lactobacillus acidophilus load from baseline to 4 weeks after the intervention, measured using quantitative real-time polymerase chain reaction (qRT-PCR).
Measured: Baseline and 4 weeks after intervention
Secondary outcomes (3)
Clinical evaluation of plaque accumulation using Oral Hygiene Index Simplified
Change in the total Oral Hygiene Index-Simplified (OHI-S) score from baseline to 4 weeks after the intervention. The total score is calculated as the sum of the Simplified Debris Index (DI-S) and the Simplified Calculus Index (CI-S), ranging from 0 to 6.
Measured: Baseline and 4 weeks after intervention
Evaluation of Salivary pH.
Change in salivary pH from baseline to 4 weeks after the intervention, measured using a calibrated digital pH meter.
Measured: Baseline and 4 weeks after intervention
Evaluation of Buffering capacity
Change in salivary buffering capacity from baseline to 4 weeks after the intervention, assessed using the acid-titration method.
Measured: Baseline and 4 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Sep 2026
- Primary completion15 Oct 2026
- Study completion15 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries in ChildrenStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a parallel assignment model in which participants are randomly allocated into three groups: An experimental group receiving probiotic lozenges containing Streptococcus salivarius, Lactobacillus reuteri, and Lactobacillus paracasei once daily for four weeks. A positive control group receiving xylitol-based moisturizing lozenges. A negative control group receiving no lozenges. All participants will follow standardized oral hygiene instructions throughout the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sally Bashar Fahd, Ain Shams University
- Investigators
- Nour Wahba, Study chair, Ain Shams University - Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904221
- Sponsor's protocol ID
- PED-25_M-7
- Status last verified
- Oct 2026
- First submitted
- 29 Jul 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Antibacterial Effect of Probiotics on Cariogenic Bacteria in Children : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07904221
- Acronym / sponsor ID
- PED-25_M-7
- Conditions
- Dental Caries in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 15 Oct 2026 (actual)
- Study completion
- 15 Oct 2026 (actual)
- First posted
- 29 Oct 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 randomized controlled clinical trial aims to evaluate the effect of oral probiotic lozenges containing Streptococcus salivarius, Lactobacillus reuteri, and Lactobacillus paracasei on cariogenic bacteria (Streptococcus mutans, Lactobacillus acidophilus) , salivary pH, buffering capacity, and plaque accumulation in children aged 6-12 years at high caries risk. Sixty children will be assigned into three groups: probiotic, positive control (xylitol lozenges), and negative control (no lozenges). Salivary and plaque parameters will be assessed before and after a 4-week intervention period.
Detailed description
- Abstract
Statement of the problem:
Tooth decay is a common problem among children that significantly affects their oral health. Traditional preventive measures have achieved limited success. Therefore, this study aims to explore the potential of probiotic lozenges to improve oral health by reducing harmful bacteria and enhancing saliva properties, providing a new preventive approach.
The aim of this study is to:
- 1) Evaluate the antibacterial effect of oral probiotics lozenges containing Streptococcus salivarius, Lactobacillus reuteri, and Lactobacillus paracasei on the levels of cariogenic bacteria including Streptococcus mutans and Lactobacillus acidophilus in 6-12 year old children.
- Evaluate the effect of the same type of probiotics lozenges on the salivary pH and buffering capacity of the saliva in 6-12 year old children.
- Evaluate the effect of the same type of probiotics lozenges on plaque accumulation in 6-12 year old children.
Materials and methods:
- This is a single -blinded randomized controlled clinical trial that will involve children aged 6 to 12 years. Participants will be randomly selected, and their caries risk assessment (CAMBRA) will be evaluated for choosing 60 children with high caries risk.
- plaque accumulation will be measured using Oral Hygiene Index Simplified.
- Unstimulated pre-salivary samples will be collected.
- The salivary sample will be analyzed for the levels of Streptococcus mutans, Lactobacillus acidophilus, salivary pH, and buffering capacity.
- The children will be divided into three groups: an experimental group and two control groups. The experimental group will be provided with oral probiotic lozenges containing Streptococcus salivarius, Lactobacillus reuteri, and Lactobacillus paracasei for daily consumption once a day at home over a period of four weeks. The first control group will receive xylitol-based moisturizing lozenges as a positive control once a day, while the second control group will serve as a negative control, receiving no lozenges. All groups will be instructed to maintain standardized oral hygiene practices, and will be provided with fluoridated toothpaste and toothbrushes.
- After four weeks, plaque accumulation will be remeasured using Oral Hygiene Index Simplified.
- post-salivary samples will be collected and analyzed for the same parameters, including the levels of Streptococcus mutans, Lactobacillus acidophilus, salivary pH, and buffering capacity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This study uses a parallel assignment model in which participants are randomly allocated into three groups: An experimental group receiving probiotic lozenges containing Streptococcus salivarius, Lactobacillus reuteri, and Lactobacillus paracasei once daily for four weeks. A positive control group receiving xylitol-based moisturizing lozenges. A negative control group receiving no lozenges. All participants will follow standardized oral hygiene instructions throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Probiotic Lozenges Group | Experimental | Dietary Supplement: Probiotic lozenges containing Streptococcus salivarius, Lactobacillus reuteri, and Lactobacillus paracaseiParticipants will receive oral probiotic lozenges containing Streptococcus salivarius, Lactobacillus reuteri, and Lactobacillus paracasei. Lozenges will be administered once daily at home for 4 weeks. |
| Xylitol Lozenges Group | Active comparator | Dietary Supplement: Xylitol-based moisturizing lozengesParticipants will receive xylitol-based moisturizing lozenges once daily at home for 4 weeks. |
| No Lozenges Group | No intervention | –Participants will not receive any lozenges but will follow standardized oral hygiene practices during the 4-week period. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 6-12-year-old children.
- High caries risk patient according to caries risk assessment (CAMBRA).
Key exclusion criteria (4 listed)
- Patients or parents who refuse to participate.
- Children who have received antibiotics or corticosteroids in the previous 48 hours before being recruited.
- Children with mental and physical disabilities.
- Orphaned children.
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 lozenges containing Streptococcus salivarius, Lactobacillus reuteri, and Lactobacillus paracaseiAlso: SUPERTEETH DENTAL PROBIOTICParticipants in this group will receive oral probiotics lozenge for daily consumption for 28 days ,once a day (probiotic containing mainly Streptococcus salivarius, Lactobacillus reuteri, and Lactobacillus paracasei). Participants will be instructed to maintain standard oral hygiene practices using fluoridated toothpaste. | Dietary supplement | Probiotic Lozenges Group |
| Xylitol-based moisturizing lozengesAlso: XyliDENTParticipants in this group will receive one xylitol-based moisturizing lozenge daily for four weeks. The lozenge is to be taken once a day at home. Participants will follow the same oral hygiene instructions as the other groups. | Dietary supplement | Xylitol Lozenges Group |
Primary outcome
Salivary load of Streptococcus mutans
Time frame: Baseline and 4 weeks after intervention
Change in salivary Streptococcus mutans load from baseline to 4 weeks after the intervention, measured using quantitative real-time polymerase chain reaction (qRT-PCR).
Salivary load of Lactobacillus acidophilus
Time frame: Baseline and 4 weeks after intervention
Change in salivary Lactobacillus acidophilus load from baseline to 4 weeks after the intervention, measured using quantitative real-time polymerase chain reaction (qRT-PCR).
3 secondary outcomes
Clinical evaluation of plaque accumulation using Oral Hygiene Index Simplified
Time frame: Baseline and 4 weeks after intervention
Evaluation of Salivary pH.
Time frame: Baseline and 4 weeks after intervention
Evaluation of Buffering capacity
Time frame: Baseline and 4 weeks after intervention
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 29 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Nour Wahba study chair
Ain Shams University - Faculty of Dentistry
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 lozenges containing Streptococcus salivarius, Lactobacillus reuteri, and Lactobacillus paracasei and Xylitol-based moisturizing lozenges in people with Dental Caries in Children, 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 29 Oct 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?
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?
Salivary load of Streptococcus mutans (time frame: Baseline and 4 weeks after intervention). The study lists 2 primary outcomes in all. 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 29 Oct 2026.