A clinical trial to assess the effect of time-to-time maternal oral health counselling though psychological / oral health interventions on the caries incidence of both pregnant women and their childre
- Conditions
- Health Condition 1: K026- Dental caries on smooth surfaceHealth Condition 2: O00-O9A- Pregnancy, childbirth and the puerperium
- Registration Number
- CTRI/2022/07/044124
- Lead Sponsor
- Amrita School of Dentistry
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Nulliparous pregnant women aged 20-35 years.
2. Non cavitated or restorable dental carious lesions [ICDAS 1-5] of DMFT = 3, consenting to fulfil all their dental needs at the prescribed study interval.
3. Understands the importance of dental caries prevention and accepts preventive dental measures as beneficial for themselves and their children.
4. Absence of any relevant systemic medical condition.
5. Consent to comply with all the trial requirements.
1. High risk and multiple pregnancies
2. Developmental dental abnormalities or grossly destructed teeth that may be difficult to restore or undergo surgical removal during the trial period.
3. With known cognitive and psychological impairment.
4. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial.
5. Participants who have participated in any similar research trial in the past 12 weeks.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dental Caries incidence of infantsTimepoint: Age 1 and 2 of infants
- Secondary Outcome Measures
Name Time Method DMFT, Gingival index and Caries Risk Assessment of the motherTimepoint: 3rd and 7th month of gestation, 1 and 2 years post-delivery;Oral Health Knowledge, Attitudes and Practices (KAP) of infant caregivers.Timepoint: At Age 1 and 2 of infant;Oral Health Knowledge, Attitudes and Practices (KAP) of mothersTimepoint: 3rd month of gestation, 1 and 2 years post delivery.;Postnatal Infant Attachment of mothersTimepoint: Mothers at 4weeks, 4 months, 8months, 1 year and 2 years post delivery;Prenatal Maternal Fetal attachment of mothersTimepoint: 7th month of gestation