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Effects of probiotics on oral microorganisms causing dental caries

Comparative evaluation of Probiotic Streptococcus salivarius K12 and M18 lozenges on salivary Streptococcus mutans and Lactobacillus counts in school going children: A Randomized Controlled Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/074311
Enrollment
75
Registered
2024-09-25
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Preventive dental care: Dental caries is one of the most prevalent chronic diseases affecting both adults and children globally. Probiotics have emerged as a promising intervention for

Sponsors

Dr Dipanshu Kumar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children aged 6 to 12 years with or without dental caries. 2. Participants must be in good general health as determined by a medical history and physical examination. 3. Parents or guardians must provide written informed consent, and children must provide assent.

Exclusion criteria

Exclusion criteria: Children who have taken antibiotics or probiotics within the past 4 weeks. Children with any chronic illness or condition that could affect oral health or saliva production Children with a history of allergies to probiotics or any components of the lozenges or gummies. Children who are unable to comply with the study protocol, including regular attendance for follow-up visits. Children with a history of chronic use of medications that may affect oral flora, such as long-term steroid therapy.

Design outcomes

Primary

MeasureTime frame
The change in the counts of Streptococcus mutans and Lactobacillus in salivaTimepoint: 1. Baseline 2. 1-hour post consumption 3. After 7 days

Secondary

MeasureTime frame
1. The change in the pH and buffering capacity of saliva from baseline to 1-hour post consumption and after 7 days. 2. Adherence to and acceptability of the interventions, assessed through participant and caregiver reports and pill counts.Timepoint: 1. Baseline 2. 1-hour post consumption 3. After 7 days

Countries

India

Contacts

Public ContactDr Dipanshu Kumar

Department of Dentistry, AIIMS, Gorakhpur

drdipanshu.kumar@gmail.com9013190478

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026