Family-centered Oral Health Promotion for New Parents

Dental Caries Clinical Trial

Official title:

Family-centered Oral Health Promotion for New Parents and Their Infants: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02937194
• Other study ID #: GRF HKU 782213M
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: December 2019

Study information

• Verified date: March 2021
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Early childhood caries (ECC) is a global health problem that causes pain and infection to the children affected. It is a common disease among preschool children in Hong Kong. There is a great need to improve at-home ECC preventive measures through oral health promotional activities as early as possible to parents.

The investigators will propose a 4-year randomized controlled trial of family-centered oral health promotion for new parents which aims to increase the proportion of parents brushing their infants' teeth at 1 year, establishing proper feeding and dietary habits, reducing the transfer of MS from the parents to their infants and then reducing the risk of ECC of the children at 3 years. The investigators also aim to improve the oral hygiene status of the new parents and prevention of oral diseases among themselves.

First-time expectant mothers and their husbands will be recruited. The recruited families will be randomly allocated to the test and control groups. In the test group, personal hygiene instruction (OHI) for the expectant mothers and their husbands together with oral health education materials on infant's tooth development and eruption, establishment of proper feeding, dietary and toothbrushing habits will be given before the delivery of the new born babies. Reinforcement of OHI and demonstrations on how to clean the infant's oral cavities and perform toothbrushing will be delivered after the babies are born. Comprehensive data will be collected from the mothers, fathers and the infants in both the test and control groups at different time points through dental examination, biological testing and questionnaire survey. The CONSORT statement will be strictly followed when conducting the clinical trial, analyzing the data and reporting the results.

It is anticipated that the effectiveness of oral health promotion starting at the pregnancy period and for both expecting mothers and their husbands will be greater in preventing the infants from developing ECC. Furthermore, establishing good oral health care habits will have long term benefits, helping safeguard the oral health of the children as they grow and the family as a whole. This study will also provide much needed evidence for the further development of oral health policies and oral health promotion programmes in Hong Kong; specifically how these can be integrated into family health education so as to achieve a higher effectiveness. This will contribute significantly to the improvement of oral health in the population of Hong Kong.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 580
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• First-time pregnancy

• Of Chinese ethnicity

• Ability to speak Cantonese and read traditional Chinese

Exclusion Criteria:

• Pregnant women with any communication difficulties noted

• Informed consent not obtained

Related Conditions & MeSH terms

• Dental Caries

Intervention

Behavioral:
• Personal oral health instruction + pamphlets distribution
Personal oral health instruction (OHI) and oral health pamphlets distribution
• Pamphlets distribution
Oral health pamphlets distribution

Locations

Country	Name	City	State
China	The University of Hong Kong	Hong Kong

Sponsors (3)

Lead Sponsor	Collaborator
The University of Hong Kong	Department of Health, Hong Kong SAR Government, Hospital Authority, Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early Childhood Caries (ECC)	Prevalence of early childhood caries (ECC) among study children at 36 months	36 months
Primary	Parental Toothbrushing on Infants	Proportion of parents who brushed their infants' teeth regularly twice daily at 12 months	12 months
Secondary	Feeding Habits on Infants	Proportion of infants falling asleep during milk-feeding	12 months
Secondary	Ratio of Mutans Streptococci (MS)	Proportion of MS with respect to the total bacterial count	24 months
Secondary	Mothers' Gingival Bleeding	Percentage of probing sites with gingival bleeding (BOP%, range 0-100%)	12 months