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 children

Assessment of the Effect of Pre-natal and Post-natal Maternal Behavioral Change Communication (BCC) intervention on the Dental Caries Experience of their children - BCC-DPHP

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/07/044124

Enrollment

450

Registered

2022-07-19

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K026- Dental caries on smooth surface Health Condition 2: O00-O9A- Pregnancy, childbirth and the puerperium

Interventions

Intervention1: Psychological Intervention: The psychological intervention will comprise of two video lectures on Prenatal Bonding. One Lecture will be approximately 15–20-minute duration and will be s

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Dental Caries incidence of infantsTimepoint: Age 1 and 2 of infants	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactDr Balagopal R Varma

Amrita School of Dentistry

balvarma@hotmail.com9447032358

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026