Clinical trial NCT02937194: Family-centered Oral Health Promotion for New Parents
Official title: Family-centered Oral Health Promotion for New Parents and Their Infants: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: Early childhood caries (ECC)
Oral health promotion
Randomized controlled trial
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hong Kong Government
name: Hospital Authority, Hong Kong
First posted: 2016-10-18
Enrollment: 580
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Early Childhood Caries (ECC)
timeFrame: 36 months
measure: Parental Toothbrushing on Infants
timeFrame: 12 months
Secondary outcomes:
measure: Feeding Habits on Infants
timeFrame: 12 months
measure: Ratio of Mutans Streptococci (MS)
timeFrame: 24 months
measure: Mothers' Gingival Bleeding
timeFrame: 12 months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The University of Hong Kong
Study officials:
References:
citation: 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.
citation: 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.