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 - Informed Consent Form
   Response - Clinical Study Report
   
   
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 - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (dayaswathi@gmail.com).
   


6. For how long will this data be available start date provided 25-06-2024 and end date provided 26-06-2025?
   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

This study focuses on evaluating the effectiveness of platelet-rich fibrin (PRF) and PRF-based nano biomaterials as pulpotomy agents in vital young permanent first molars in children aged 7-9 years. The randomized controlled trial aims to assess both clinical and radiographic outcomes of these treatments over intervals of 3, 6, 9, and 12 months. Key clinical criteria include the presence of pain, swelling, tenderness on percussion, pathological mobility, and purulent discharge, while radiographic criteria include the assessment of periapical radiolucency, furcal involvement, and root resorption. Additionally, the study monitors the duration required for apical closure.

Participants will be selected based on specific inclusion criteria, such as having caries in permanent mandibular first molars requiring vital pulp therapy, deep dentin caries with pulp exposure, and mild to moderate responses to stimuli. Teeth must be in Nolla’s stage 7 or 8 of root development. Exclusion criteria include teeth with irreversible pulpitis, mobility, abscesses, fistulas, significant radiolucency, and internal or external root resorption. Children with systemic problems, congenital abnormalities, or special needs are also excluded.

The study involves preparing PRF using Choukroun’s technique and agglomerating it with nanomaterials to ensure uniform distribution. The procedure includes local anesthesia, rubber-dam isolation, cavity preparation, and caries removal, followed by the application of the assigned pulpotomy agents. The PRF and nanomaterial mixture will be applied in a 3:1 ratio, covering the chamber floor and followed by Glass Ionomer Cement (GIC) and composite restoration. Radiographs will be taken using a standardized technique to ensure consistency.

The research aims to determine if the addition of nano chitosan and nano-hydroxyapatite to PRF enhances the healing process and accelerates the clinical outcomes, specifically the apical closure. By standardizing the treatment duration for apical closure in teeth at Nolla’s stage 7 and 8, the study could potentially extend the applicability of these biomaterials to teeth at various stages of root development. This could provide a more effective and faster treatment option for children with cariously exposed pulp in young permanent teeth, leveraging the regenerative properties of PRF and the biocompatibility of nano chitosan and nano-hydroxyapatite.