1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   
   
3. Who will be able to view these files?
   Response - Researchers who provide a methodologically sound proposal.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [sakshisharan123@gmail.com].
   


6. For how long will this data be available start date provided 14-11-2026 and end date provided 31-12-2030?
   Response - Beginning 3 months and ending 5 years following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Dental caries is among the most prevalent chronic diseases in children globally, affecting 60–90% of school-aged children according to the World Health Organization. It is primarily caused by the acidogenic activity of Streptococcus mutans, which thrives in dental biofilms formed in poor oral hygiene conditions. While fluoride-based toothpastes have long been the cornerstone of caries prevention, their excessive ingestion in children under 6 years can lead to dental fluorosis and systemic complications. This concern becomes more pressing in fluoride-rich regions like Chhattisgarh, where natural groundwater contains fluoride levels that often exceed the WHO safety limit of 1.5 mg/L, contributing to a high prevalence of Molar Incisor Hypomineralization (MIH) and enamel developmental defects.

To address this challenge, the present study proposes the development of a fluoride-free pediatric toothpaste, named Probiodent, incorporating two synergistic agents: a probiotic strain known for its anti-S. mutans activity and nano-hydroxyapatite, a synthetic biomimetic agent proven to aid in enamel remineralization comparable to or even better than fluoride in children.

The toothpaste will be formulated in a government-authorized laboratory at Smt Kishoritai Bhoyar College of Pharmacy, tested for physical parameters including pH, viscosity, spreadability, and foamability, and benchmarked against commercial pediatric dentifrices to determine its safety and suitability for daily use. 

In the second phase, in-vitro microbial testing will be conducted at the Department of Microbiology, Rungta College of Dental Sciences and Research. This will be followed by SEM analysis to check the remineralisation potential at IIT Bhilai. This study aims to provide a regionally relevant, biologically safe, and clinically effective alternative to fluoride toothpastes in pediatric dental care.