1. What data in particular will be shared?
   Response (Others) -  De-identified individual participant data (IPD) underlying the results of the study will be shared upon reasonable request after publication of the primary results.


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response (Others) -  any other flow-charts or diagrams describing the study better
   
3. Who will be able to view these files?
   Response (Others) -  Researchers needing any additional information apart from that mentioned above will be provided the needful after they contact the corresponding author.


4. For what types of analyses will this data be available?
   Response (Others) -  The analyses thata will help achieve aims of the approved proposal


5. By what mechanism will data be made available?
   Response (Others) -  Link to the publication will be accessible indefinitely


6. For how long will this data be available start date provided 01-12-2028 and end date provided 01-12-2046?
   Response (Others) -  There will be no end date


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

Need for Research:

The prevalence of Early Childhood Caries (ECC) in India is quite high (49.6%). Treatment of ECC involves both, increased expenses as well as health risks. There is also an associated high rate of recurrence after such treatments. The major risk factors for Severe-ECC are often attributed to various pre, peri and post-natal causes like Maternally Derived S.Mutans Disease (MDSMD) and developmental defects in enamel due to low birth weight infants. It is well established that primary preventive intervention and oral-health instruction can significantly inhibit the MS levels of mothers and prevent caries in their children during the early years of life. This makes perinatal counselling one of the key elements of infant oral health care. Both, World Dental Federation (FDI) as well as the Indian Association of Paediatric Dentistry (IAPD) recommend a multidisciplinary approach for management of multiple risk factors associated with ECC. Apart from the dental personnel, it includes their parents, pediatricians and medical specialists, as well as any primary caregiver of the child.

Hence addressing this issue with evidence- based oral health is of utmost importance. Besides, the data for such studies from India is lacking.

Brief Resume of the Proposed Research

Background The major risk factors for Early Childhood Caries(ECC) are often attributed to various pre, peri and post-natal causes. Hence, the aim of this prospective study is to assess the effectiveness of multi-disciplinary perinatal behavioural and therapeutic interventions by maternal and child health care providers along with oral health professionals in expectant mothers and their children for prevention of ECC. Methodology This study will be conducted on 200 mother-child pairs who will be randomly allocated into either a study group or a control group (n 55 each). Mothers in the study group will be provided behavioural interventions such as 1) Oral Health Education at baseline, 2) pre-natal referrals by gynaecologists to paediatric dentists in the second trimester, 3) post-natal referrals by paediatricians to paediatric dentists at 1 month after birth, 4) pre and post-natal sustained anticipatory guidance by paediatric dentists. Therapeutic interventions will include oral examination of mothers and determination of their treatment needs, providing fluoride toothpastes, referrals to dentists for oral prophylaxis and caries stabilisation and any urgent dental care if necessary. There will be periodic re-enforcements of all the sessions by means of follow-up with phone calls and reminder messages twice monthly. Those in the control group will undergo one episode of oral health education and pre and post-natal anticipatory guidance by paediatric dentists at baseline. There will not be any pre and post-natal referrals from to paediatric dentists from the gynaecologists and paediatricians respectively. Therapeutic interventions will remain the same as the study group. However, there will not be any re-enforcements or follow-up of either the educational or the therapeutic sessions in this group. Caries Risk Assessment for both the groups will be done at baseline, 9 months pre-partum and at 6,12,18 months post-delivery for the mothers using the cariogram tool and at 6, 12 and 18 months after birth for children using the CRAFT tool. Novelty This will be one of the first studies to evaluate the effectiveness of inter-disciplinary perinatal interventions in India. Expected Outcome Based on the results of previous studies, such interventions in pregnant mothers are expected to prevent caries in children in early years of their life.