Skip to content

Family-centered Oral Health Promotion for New Parents

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02937194
Enrollment
580
Registered
2016-10-18
Start date
2014-06-30
Completion date
2019-12-31
Last updated
2021-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

Keywords

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

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.

Interventions

BEHAVIORALPersonal oral health instruction + pamphlets distribution

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

BEHAVIORALPamphlets distribution

Oral health pamphlets distribution

Sponsors

Hong Kong Government
CollaboratorOTHER_GOV
Hospital Authority, Hong Kong
CollaboratorOTHER_GOV
The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Early Childhood Caries (ECC)36 monthsPrevalence of early childhood caries (ECC) among study children at 36 months
Parental Toothbrushing on Infants12 monthsProportion of parents who brushed their infants' teeth regularly twice daily at 12 months

Secondary

MeasureTime frameDescription
Feeding Habits on Infants12 monthsProportion of infants falling asleep during milk-feeding
Ratio of Mutans Streptococci (MS)24 monthsProportion of MS with respect to the total bacterial count
Mothers' Gingival Bleeding12 monthsPercentage of probing sites with gingival bleeding (BOP%, range 0-100%)

Countries

China

Participant flow

Recruitment details

The pregnant women and their husbands were recruited from the Obstetrics & Gynaecology Department of three public hospitals and from two Maternal and Child Health Centers in Hong Kong. The potential participants were approached during their prenatal visits with minimal disturbance to the routine care at the recruitment sites. Written informed consent was obtained from both the pregnant woman and the husband. The recruitment period was from June 2014 to June 2016.

Participants by arm

ArmCount
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. Personal oral health instruction + pamphlets distribution: Personal oral health instruction (OHI) and oral health pamphlets distribution
294
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. Pamphlets distribution: Oral health pamphlets distribution
286
Total580

Baseline characteristics

CharacteristicPersonal Oral Health Instruction + Pamphlets DistributionPamphlets DistributionTotal
Age, Continuous33.9 years
STANDARD_DEVIATION 5.1
33.4 years
STANDARD_DEVIATION 5.2
33.6 years
STANDARD_DEVIATION 5.1
Race/Ethnicity, Customized
Chinese
294 Families286 Families580 Families
Sex/Gender, Customized
Father
294 Families286 Families580 Families
Sex/Gender, Customized
Mother
294 Families286 Families580 Families

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2940 / 286
other
Total, other adverse events
0 / 2940 / 286
serious
Total, serious adverse events
0 / 2940 / 286

Outcome results

Primary

Early Childhood Caries (ECC)

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

Time frame: 36 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Personal Oral Health Instruction + Pamphlets DistributionEarly Childhood Caries (ECC)8 Participants
Pamphlets DistributionEarly Childhood Caries (ECC)41 Participants
Primary

Parental Toothbrushing on Infants

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

Time frame: 12 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Personal Oral Health Instruction + Pamphlets DistributionParental Toothbrushing on Infants74 Participants
Pamphlets DistributionParental Toothbrushing on Infants76 Participants
Secondary

Feeding Habits on Infants

Proportion of infants falling asleep during milk-feeding

Time frame: 12 months

Population: The numbers of participants analyzed here are those who finished basiline and one-year follow-up examination.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Personal Oral Health Instruction + Pamphlets DistributionFeeding Habits on Infants57 Participants
Pamphlets DistributionFeeding Habits on Infants63 Participants
Secondary

Mothers' Gingival Bleeding

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

Time frame: 12 months

Population: The numbers of participants analyzed here are those who finished basiline and one-year follow-up gingival bleeding examination.

ArmMeasureValue (MEAN)Dispersion
Personal Oral Health Instruction + Pamphlets DistributionMothers' Gingival Bleeding35 Percentage of sites with bleedingStandard Deviation 29
Pamphlets DistributionMothers' Gingival Bleeding46 Percentage of sites with bleedingStandard Deviation 26
Secondary

Ratio of Mutans Streptococci (MS)

Proportion of MS with respect to the total bacterial count

Time frame: 24 months

ArmMeasureValue (MEAN)Dispersion
Personal Oral Health Instruction + Pamphlets DistributionRatio of Mutans Streptococci (MS)6.1 Ratio of MS in the total bacterial countStandard Deviation 15.7
Pamphlets DistributionRatio of Mutans Streptococci (MS)11.6 Ratio of MS in the total bacterial countStandard Deviation 17.8

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026