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
   Response - Informed Consent Form
   Response - Clinical Study Report
   Response -  Analytic Code
   
   
3. Who will be able to view these files?
   Response - Anyone
   


4. For what types of analyses will this data be available?
   Response - Any purpose.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [rao.apeksha97@gmail.com].
   


6. For how long will this data be available start date provided 01-04-2023 and end date provided 07-01-2025?
   Response - Immediately following publication. No end date.
   


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

Dental resin composites have revolutionized dental care and enabled minimally invasive dentistry to preserve healthy tooth structure and provide natural-appearing esthetic results¹.

Nevertheless, the development of recurrent caries at tooth-restoration interfaces still remains as one of the principal reasons for replacement of different kinds of restorations.

Based on this, one of the greatest challenges in the field of restorative dentistry involves the development of restorative biomaterials that have the ability of avoiding demineralization or promoting remineralization of hard dental tissues affected by caries ².

Bioactive materials promote a biological response at the interface of the material and the tissue, generating a union between them³.

Manufacturers have claimed Bioactive dental materials help regulate the chemistry of teeth and saliva and contribute to the maintenance of oral health.

This type of bioactivity is known in the field to equate to stronger bonds between the restoration and tooth, penetration and filling of micro-gaps, reduction in sensitivity, guarding against secondary caries, and sealing of margins against microleakage and failure.

Such material is also indicated in cases where the isolation is compromised or impossible and in patients with high caries index due to its fluoride-releasing properties

3Mâ„¢ Filtekâ„¢ Bulk Fill Posterior Restorative (3M, ESPE) is a nanocomposite composite material showing no bioactive properties

Predicta Bioactive Bulk (PREDICTA, Parkell) is bioactive and releases calcium and phosphate ions and releases and recharges fluoride ions to stimulate mineral apatite formation and remineralization at the material-tooth interface.

Since bioactive composites have reminearlizing and antibacterial effect, we would like to evaluate the same properties in high caries risk individuals. Since there is no literature comparing the bioactive composites with non bioactive composites, we would like to evaluate the same in high caries risk patients.

PURPOSE OF STUDY:

To compare bioactive and non-bioactive composite resin in class V lesions of high-risk caries patients by using FDI criteria.

 OBJECTIVES OF THE STUDY:

• To assess the marginal staining, marginal adaptation, marginal gap and recurrence of caries in bioactive composite Predicta Bioactive Bulk (PREDICTA, Parkell) in high caries risk patients using FDI criteria.
• To assess the marginal staining, marginal adaptation, marginal gap and recurrence of caries in non-bioactive composite 3Mâ„¢ Filtekâ„¢ Bulk Fill Posterior Restorative (3, ESPE) in high caries risk patients using FDI criteria.
• To compare bioactive and non-bioactive composites on the basis of marginal staining, marginal adaptation, marginal gap and recurrence of caries in high caries risk patients using FDI criteria.