Family-centered Oral Health Promotion for New Parents

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Behavioral: Personal oral health instruction + pamphlets distribution; Behavioral: Pamphlets distribution

• Study Type: Interventional
• Enrollment (Actual): 580
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • The University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personal oral health instruction + pamphlets distribution; Personal oral health 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 baby delivery. 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.	Behavioral: Personal oral health instruction + pamphlets distribution; Personal oral health instruction (OHI) and oral health pamphlets distribution
Active Comparator: Pamphlets distribution; Pamphlets for adults' and pregnant women's oral health care will be distributed when recruited and information on the babies' oral health care will be distributed before baby delivery.	Behavioral: Pamphlets distribution; Oral health pamphlets distribution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early Childhood Caries (ECC)	Prevalence of early childhood caries (ECC) among study children at 36 months	36 months
Parental Toothbrushing on Infants	Proportion of parents who brushed their infants' teeth regularly twice daily at 12 months	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feeding Habits on Infants	Proportion of infants falling asleep during milk-feeding	12 months
Ratio of Mutans Streptococci (MS)	Proportion of MS with respect to the total bacterial count	24 months
Mothers' Gingival Bleeding	Percentage of probing sites with gingival bleeding (BOP%, range 0-100%)	12 months

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Hospital Authority, Hong Kong; Department of Health, Hong Kong SAR Government

Publications and helpful links

General Publications

• Yu KF, Wen W, Liu P, Gao X, Lo ECM, Wong MCM. Effectiveness of Family-Centered Oral Health Promotion on Toddler Oral Health in Hong Kong. J Dent Res. 2022 Mar;101(3):286-294. doi: 10.1177/00220345211036663. Epub 2021 Sep 13.
• Liu P, Wen W, Yu KF, Gao X, Lo ECM, Wong MCM. Effectiveness of a family-centered behavioral and educational counselling approach to improve periodontal health of pregnant women: a randomized controlled trial. BMC Oral Health. 2020 Oct 16;20(1):284. doi: 10.1186/s12903-020-01265-6.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: October 5, 2016
• First Submitted That Met QC Criteria: October 16, 2016
• First Posted (Estimate): October 18, 2016

Study Record Updates

• Last Update Posted (Actual): April 22, 2021
• Last Update Submitted That Met QC Criteria: March 26, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Oral health promotion; Early childhood caries (ECC)
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: GRF HKU 782213M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED