Family-centered Oral Health Promotion for New Parents

Study Overview
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Brief Summary
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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.

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

Conditions
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Dental Caries

Intervention / Treatment
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* Behavioral: Personal oral health instruction + pamphlets distribution
* Behavioral: Pamphlets distribution


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personal oral health instruction + pamphlets distribution<br>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<br>* Personal oral health instruction (OHI) and oral health pamphlets distribution<br>|
| Active Comparator: Pamphlets distribution<br>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<br>* Oral health pamphlets distribution<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral health promotion, Early childhood caries (ECC), Randomized controlled trial