1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


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 (Others) -  Data will be published in a journal after completion of the study


6. For how long will this data be available start date provided 02-08-2022 and end date provided 02-11-2023?
   Response (Others) -  Data will be available after publishing in a journal


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

We propose to conduct a prospective observational  case-control study involving healthy children aged between 2 years to 16 years diagnosed to have extensive dental caries or dental problems other than caries, presenting to either the department of Paediatrics unit 1, Kasturba Hospital, Manipal or the department of Paedodontics, Manipal College of Dental Sciences, Manipal. Children with extensive dental caries will be considered as cases and children with no dental caries undergoing dental evaluation for any other cause would be taken as controls. Institutional ethics committee approval will be obtained prior to the commencement of the study. The study will be registered under CTRI. A written informed consent will be obtained from care givers of each child prior to the recruitement into the study. A detailed history of presenting illness including dental history will be recorded. A detailed diet history and exposure to sunlight will be recorded. Oral examination of each child will be done by the investigator from Paedodontics department. Caries status of the children will be recorded using decayed, extracted, missing and filled teeth (DMFT) index. A detailed systemic examination will be conducted by the investigator from Paediatrics department unit 1. History and physical examination findings will be recorded in control population similar to the cases. A venous blood approximately 2.5ml will be obtained from the study participants (cases and controls) and sent to the biochemistry laboratory for estimation of serum vitamin D levels. Serum Vitamin D levels less than 20 ng/ml will be considered as deficient. All the data will be compiled and subjected to statistical analysis using mean, paired t-test, and simple linear regression, and compilation of the result will be done. The serum vitamin D levels will be compared between cases and controls for statistical significance.

Faculty seed money grant of INR 35000 has been approved for the study from MAHE (Seed money ID: 00000521). The cost of vitamin D levels testing is INR 1140 per sample at Kasturba Hospital Laboratory. As per the research policy 20% discount has been approved for the test samples. Hence the cost of Vitamin D level test would be INR 912 for the study subjects. A total of 38 samples will be tested as per the budget.