An interventional study of Probiotic lozenges containing Streptococcus salivarius, Lactobacillus reuteri, and Lactobacillus paracasei and Xylitol-based moisturizing lozenges in Dental Caries in Children, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Ain Shams University · Not applicable, Interventional, and Prevention
Among 17 studies in Dental Caries by Ain Shams University — 5 open to participants now, 7 under way, none of them phase 3. Dental Caries · Ain Shams University.
Among the 17 studies in Dental Caries by Ain Shams University, this one is the 6th largest by enrollment of the 15 interventional ones, is the only one that started in 2026, is one of 12 with no phase, and was the 14th registered.
1,171 studies on the registry are indexed under Dental Caries; 209 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 967 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →5 of the 17 studies in Dental Caries by Ain Shams University are open now, in 1 country. Each count lists the studies.
Of the 86 Dental Caries studies recruiting now, 18 (21%) set no upper age limit and 66 (77%) stop at 75 or younger; 60 take children under 18; 53 take healthy volunteers.
This study: 6 Years to 12 Years · all sexes · healthy volunteers too.
The full table on the hub →17 studies; the count open now beside each. This study's row is marked.
First in 2018; this study’s year is marked. 1 started in 2026.
Median enrollment 40 across the 15 interventional studies, 276 across the 2 observational. Of the 9 that completed or were terminated, 0 (0%) have results posted.
Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
1 of the studies in Dental Caries by Ain Shams University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05943782Ain Shams UniversityEvaluation of CAD/CAM Onlays Fabricated by Subtractive Versus Additive Digital Manufacturing Techniques. | 2026-12-01 |
Among the 17 studies in Dental Caries by Ain Shams University, from their registry updates:
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.
I. 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:
2) 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.
3) Evaluate the effect of the same type of probiotics lozenges on plaque accumulation in 6-12 year old children.
Materials and methods:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: Probiotic lozenges containing Streptococcus salivarius, Lactobacillus reuteri, and Lactobacillus paracasei
Participants will receive xylitol-based moisturizing lozenges once daily at home for 4 weeks.
Dietary Supplement: Xylitol-based moisturizing lozenges
Participants will not receive any lozenges but will follow standardized oral hygiene practices during the 4-week period.
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.
Also known as: SUPERTEETH DENTAL PROBIOTIC
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.
Also known as: XyliDENT
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).
Time frame: 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).
Time frame: Baseline and 4 weeks after intervention
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 4 weeks after intervention
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2026 to primary completion in Oct 2026, 1 month.
Of 469 non-industry interventional studies with no phase under Dental Caries, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's 1 month is below that.
Counting every sponsor, half of 502 studies reached it within 15 months; a quarter within 7 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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