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CTRI Number  CTRI/2024/09/074311 [Registered on: 25/09/2024] Trial Registered Prospectively
Last Modified On: 05/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic
Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effects of probiotics on oral microorganisms causing dental caries 
Scientific Title of Study   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 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dipanshu Kumar 
Designation  Assistant Professor 
Affiliation  Department of Dentistry, AIIMS, Gorakhpur 
Address  OPD Room no 4, Department of Dentistry, AIIMS, Gorakhpur

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  9013190478  
Fax    
Email  drdipanshu.kumar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dipanshu Kumar 
Designation  Assistant Professor 
Affiliation  Department of Dentistry, AIIMS, Gorakhpur 
Address  OPD Room no 4, Department of Dentistry, AIIMS, Gorakhpur

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  9013190478  
Fax    
Email  drdipanshu.kumar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Dipanshu Kumar 
Designation  Assistant Professor 
Affiliation  Department of Dentistry, AIIMS, Gorakhpur 
Address  OPD Room no 4, Department of Dentistry, AIIMS, Gorakhpur

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  9013190478  
Fax    
Email  drdipanshu.kumar@gmail.com  
 
Source of Monetary or Material Support  
Department of Dentistry, AIIMS, Gorakhpur, Uttar Pradesh, 273008 
 
Primary Sponsor  
Name  Dr Dipanshu Kumar 
Address  Room no 4, Dept of Dentistry, AIIMS, Gorakhpur, UP 273008 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dipanshu Kumar  AIIMS, Gorakhpur  OPD room no 4, Department Of Dentistry
Gorakhpur
UTTAR PRADESH 		 9013190478

drdipanshu.kumar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IHEC, AIIMS, Gorakhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Children aged 6-12 years visiting Dentistry OPD  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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 oral health, particularly in the prevention and management of dental caries. This study aims to evaluate and compare the effects of Streptococcus salivarius K12 & M18 probiotic lozenges on the pH, buffering capacity, counts of S. mutans and Lactobacillus in the saliva of children aged 6 to 12 years. 
Comparator Agent  Streptococcus salivarius K12 probiotic lozenges  Oral lozenges containing 2.5 billion Streptococcus salivarius K12 strain 
Comparator Agent  Streptococcus salivarius M18 probiotic lozenges  Oral lozenges containing 2.5 billion Streptococcus salivarius M18 strain 
Comparator Agent  Sugarfree candies  Isomalt based sugarfree candies containg no added sugar used for control/placebo 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The change in the counts of Streptococcus mutans and Lactobacillus in saliva  1. Baseline
2. 1-hour post consumption
3. After 7 days  
 
Secondary Outcome  
Outcome  TimePoints 
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. 		 1. Baseline
2. 1-hour post consumption
3. After 7 days 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

According to the Global Burden of Disease Study 2017, oral diseases affect approximately 3.5 billion people worldwide, with dental caries being the most common condition. In children, especially those aged 6 to 12 years, dental caries can cause pain, difficulty eating, and disrupted sleep, adversely affecting their overall quality of life and development. Therefore, there is a critical need for effective preventive and management strategies for dental caries in this age group.

Probiotics have emerged as a promising intervention for oral health, particularly in preventing and managing dental caries. Probiotics are live microorganisms that confer health benefits to the host when administered in adequate amounts. They work by modulating the oral microbiota, inhibiting the growth of pathogenic bacteria like S. mutans, and promoting a balanced microbial ecosystem. Among various probiotic strains, Streptococcus salivarius K12 has shown potential in reducing S. mutans levels and improving oral health. Additionally, combinations of multiple probiotic strains are being investigated for their synergistic effects on oral health.

This study aims to evaluate and compare the effects of Streptococcus salivarius K12 & M18 lozenges on the counts of S. mutans and Lactobacillus in the saliva of children aged 6 to 12 years. By understanding the efficacy of these probiotics, this research hopes to contribute to the development of effective strategies for the prevention and management of dental caries in school going children.

 
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