Family-centered Oral Health Promotion for New Parents

NCT02937194 | Completed Results

• 1 other identifier: GRF HKU 782213M
• Study Type: interventional
• Target: 580
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Keywords

Early childhood caries (ECC); Oral health promotion; Randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Feeding Habits on Infants

  12 months

• Ratio of Mutans Streptococci (MS)

  24 months

• Mothers' Gingival Bleeding

  12 months

Study Arms (2)

Personal oral health instruction + pamphlets distribution

EXPERIMENTAL

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

Pamphlets distribution

ACTIVE COMPARATOR

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

Interventions

Personal oral health instruction + pamphlets distribution BEHAVIORAL

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

Personal oral health instruction + pamphlets distribution

Pamphlets distribution BEHAVIORAL

Oral health pamphlets distribution

Pamphlets distribution

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• First-time pregnancy
• Of Chinese ethnicity
• Ability to speak Cantonese and read traditional Chinese

You may not qualify if:

• Pregnant women with any communication difficulties noted
• Informed consent not obtained

Sponsors & Collaborators

• The University of Hong Kong: lead
• Hong Kong Government: collaborator
• Hospital Authority, Hong Kong: collaborator

Study Sites (1)

The University of Hong Kong

Hong Kong, China

Location

Related Publications (2)

• 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.

  PMID: 34515552 DERIVED

• 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.

  PMID: 33066773 DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Prof Wong, May Chun Mei
• Organization: The University of Hong Kong

mcmwong@hku.hk

852-28590422

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 5, 2016
• First Posted: October 18, 2016
• Study Start: June 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 22, 2021
• Results First Posted: April 22, 2021

Record last verified: 2021-03

Locations

CN (1)