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Completed

NCT Number: NCT02937194

Family-centered Oral Health Promotion for New Parents

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Hong Kong

Hong Kong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Personal oral health instruction + pamphlets distribution

Behavioral

Personal oral health instruction (OHI) and oral health pamphlets distribution

Pamphlets distribution

Behavioral

Oral health pamphlets distribution

Primary outcomes

  1. Early Childhood Caries (ECC)

    Time frame: 36 months

    Prevalence of early childhood caries (ECC) among study children at 36 months

  2. Parental Toothbrushing on Infants

    Time frame: 12 months

    Proportion of parents who brushed their infants' teeth regularly twice daily at 12 months

Secondary outcomes

  1. Feeding Habits on Infants

    Time frame: 12 months

    Proportion of infants falling asleep during milk-feeding

  2. Ratio of Mutans Streptococci (MS)

    Time frame: 24 months

    Proportion of MS with respect to the total bacterial count

  3. Mothers' Gingival Bleeding

    Time frame: 12 months

    Percentage of probing sites with gingival bleeding (BOP%, range 0-100%)

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Hong Kong Government
  • Hospital Authority, Hong Kong

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Oct 18, 2016
Registry last updated
Apr 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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