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临床试验/CTRI/2026/02/102990
CTRI/2026/02/102990尚未招募4 期

Effectiveness of multi-disciplinary pre and postnatal interventions in first-time expectant mothers and their children for the prevention of early childhood caries: A Randomized Controlled Trial

Bharati Vidyapeeth ( Deemed to be University) Dental College and Hospital, Pune2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年2月19日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
200
试验地点
2
主要终点
1. Occurrence of new carious lesions (Incidence of ECC) in children after multi-disciplinary pre and postnatal interventions

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
25.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • Healthy women, aged 25-35 years reporting to the Gynaecology OPD of Bharati Vidyapeeth Medical Hospital, Pune
  • Women in their second trimester of pregnancy
  • First Time Mothers
  • Women residing in Pune city and planning on residing here for next 3 years.

排除标准

  • Expectant Mothers with a high risk of pregnancy due to any known systemic disorders
  • Pregnant Women on long term antibiotics/ steroids/ antihistaminics/antiepileptics
  • Pregnant Women who do not consent to study
  • Newborns with any congenital conditions.

结局指标

主要结局

1. Occurrence of new carious lesions (Incidence of ECC) in children after multi-disciplinary pre and postnatal interventions

时间窗: 1.DMFT scores and Caries Risk Assessment for the mothers will be done at baseline, 9 months pre-partum and at 6 and 12 months post-delivery | 2.Caries Risk Assessment for children will be done at baseline, 6 and 12 months after birth | 3.Occurrence of ECC will be assessed at 12 months after birth | 1.Carious lesions will be detected according to ICDAS (The International Caries Detection and Assessment System) method for caries detection and staging | 2.Caries risk of the mothers will be determined using CAMBRA (Caries Management by Risk Assessment) 123 CRA Tool.

2. Occurrence of new carious lesions in first-time expectant mothers after multi-disciplinary pre and postnatal interventions

时间窗: 1.DMFT scores and Caries Risk Assessment for the mothers will be done at baseline, 9 months pre-partum and at 6 and 12 months post-delivery | 2.Caries Risk Assessment for children will be done at baseline, 6 and 12 months after birth | 3.Occurrence of ECC will be assessed at 12 months after birth | 1.Carious lesions will be detected according to ICDAS (The International Caries Detection and Assessment System) method for caries detection and staging | 2.Caries risk of the mothers will be determined using CAMBRA (Caries Management by Risk Assessment) 123 CRA Tool.

3. Changes in Caries risk of children after multi-disciplinary pre and postnatal interventions

时间窗: 1.DMFT scores and Caries Risk Assessment for the mothers will be done at baseline, 9 months pre-partum and at 6 and 12 months post-delivery | 2.Caries Risk Assessment for children will be done at baseline, 6 and 12 months after birth | 3.Occurrence of ECC will be assessed at 12 months after birth | 1.Carious lesions will be detected according to ICDAS (The International Caries Detection and Assessment System) method for caries detection and staging | 2.Caries risk of the mothers will be determined using CAMBRA (Caries Management by Risk Assessment) 123 CRA Tool.

4. Changes in Caries risk of first-time expectant mothers after multi-disciplinary pre and postnatal interventions

时间窗: 1.DMFT scores and Caries Risk Assessment for the mothers will be done at baseline, 9 months pre-partum and at 6 and 12 months post-delivery | 2.Caries Risk Assessment for children will be done at baseline, 6 and 12 months after birth | 3.Occurrence of ECC will be assessed at 12 months after birth | 1.Carious lesions will be detected according to ICDAS (The International Caries Detection and Assessment System) method for caries detection and staging | 2.Caries risk of the mothers will be determined using CAMBRA (Caries Management by Risk Assessment) 123 CRA Tool.

5. Association of caries risk between first-time expectant mothers and children after multi-disciplinary pre and postnatal interventions

时间窗: 1.DMFT scores and Caries Risk Assessment for the mothers will be done at baseline, 9 months pre-partum and at 6 and 12 months post-delivery | 2.Caries Risk Assessment for children will be done at baseline, 6 and 12 months after birth | 3.Occurrence of ECC will be assessed at 12 months after birth | 1.Carious lesions will be detected according to ICDAS (The International Caries Detection and Assessment System) method for caries detection and staging | 2.Caries risk of the mothers will be determined using CAMBRA (Caries Management by Risk Assessment) 123 CRA Tool.

次要结局

  • 1. Compliance of participants to this study design and protocol(2. Effect of various confounding variables like socio-economic factors, diet and feeding practices, effect of pre-term delivery and/or low birth weight on development of early childhood caries)

研究者

发起方
Bharati Vidyapeeth ( Deemed to be University) Dental College and Hospital, Pune
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Gandhali Malgaonkar Joshi

Bharati Vidyapeeth Dental College and Hospital,Pune

研究点 (2)

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