Family-centered Oral Health Promotion for New Parents

Sponsor
The University of Hong Kong (Other)
Overall Status
Completed
CT.gov ID
NCT02937194
Collaborator
Department of Health, Hong Kong SAR Government (Other), Hospital Authority, Hong Kong (Other)
580
Enrollment
1
Location
2
Arms
66
Actual Duration (Months)
8.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Personal oral health instruction + pamphlets distribution
  • Behavioral: Pamphlets distribution
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
580 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Family-centered Oral Health Promotion for New Parents and Their Infants: a Randomized Controlled Trial
Actual Study Start Date :
Jun 1, 2014
Actual Primary Completion Date :
Dec 1, 2019
Actual Study Completion Date :
Dec 1, 2019

Arms and Interventions

ArmIntervention/Treatment
Experimental: 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.

Behavioral: Personal oral health instruction + pamphlets distribution
Personal oral health instruction (OHI) and oral health pamphlets distribution

Active Comparator: 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.

Behavioral: Pamphlets distribution
Oral health pamphlets distribution

Outcome Measures

Primary Outcome Measures

  1. Early Childhood Caries (ECC) [36 months]

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

  2. Parental Toothbrushing on Infants [12 months]

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

Secondary Outcome Measures

  1. Feeding Habits on Infants [12 months]

    Proportion of infants falling asleep during milk-feeding

  2. Ratio of Mutans Streptococci (MS) [24 months]

    Proportion of MS with respect to the total bacterial count

  3. Mothers' Gingival Bleeding [12 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1The University of Hong KongHong KongChina

Sponsors and Collaborators

  • The University of Hong Kong
  • Department of Health, Hong Kong SAR Government
  • Hospital Authority, Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Professor May C.M. Wong, Professor, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT02937194
Other Study ID Numbers:
  • GRF HKU 782213M
First Posted:
Oct 18, 2016
Last Update Posted:
Apr 22, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Professor May C.M. Wong, Professor, The University of Hong Kong
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment DetailsThe 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.
Pre-assignment Detail
Arm/Group TitlePersonal Oral Health Instruction + Pamphlets DistributionPamphlets Distribution
Arm/Group DescriptionPersonal 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 distributionPamphlets 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
Period Title: 1-year Followup
STARTED294286
COMPLETED223218
NOT COMPLETED7168
Period Title: 1-year Followup
STARTED294286
COMPLETED216208
NOT COMPLETED7878
Period Title: 1-year Followup
STARTED294286
COMPLETED228208
NOT COMPLETED6678

Baseline Characteristics

Arm/Group TitlePersonal Oral Health Instruction + Pamphlets DistributionPamphlets DistributionTotal
Arm/Group DescriptionPersonal 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 distributionPamphlets 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 distributionTotal of all reporting groups
Overall Participants294286580
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
31.7
(3.7)
31.6
(4.2)
31.7
(4.0)
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
33.9
(5.1)
33.4
(5.2)
33.6
(5.1)
Sex/Gender, Customized (Families) [Number]
Mother
294
286
580
Father
294
286
580
Race/Ethnicity, Customized (Families) [Number]
Chinese
294
286
580

Outcome Measures

1. Primary Outcome
TitleEarly Childhood Caries (ECC)
DescriptionPrevalence of early childhood caries (ECC) among study children at 36 months
Time Frame36 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitlePersonal Oral Health Instruction + Pamphlets DistributionPamphlets Distribution
Arm/Group DescriptionPersonal 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 distributionPamphlets 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
Measure Participants228208
Count of Participants [Participants]
8
2.7%
41
14.3%
2. Primary Outcome
TitleParental Toothbrushing on Infants
DescriptionProportion of parents who brushed their infants' teeth regularly twice daily at 12 months
Time Frame12 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitlePersonal Oral Health Instruction + Pamphlets DistributionPamphlets Distribution
Arm/Group DescriptionPersonal 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 distributionPamphlets 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
Measure Participants223218
Count of Participants [Participants]
74
25.2%
76
26.6%
3. Secondary Outcome
TitleFeeding Habits on Infants
DescriptionProportion of infants falling asleep during milk-feeding
Time Frame12 months

Outcome Measure Data

Analysis Population Description
The numbers of participants analyzed here are those who finished basiline and one-year follow-up examination.
Arm/Group TitlePersonal Oral Health Instruction + Pamphlets DistributionPamphlets Distribution
Arm/Group DescriptionPersonal 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 distributionPamphlets 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
Measure Participants218223
Count of Participants [Participants]
57
19.4%
63
22%
4. Secondary Outcome
TitleRatio of Mutans Streptococci (MS)
DescriptionProportion of MS with respect to the total bacterial count
Time Frame24 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitlePersonal Oral Health Instruction + Pamphlets DistributionPamphlets Distribution
Arm/Group DescriptionPersonal 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 distributionPamphlets 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
Measure Participants216208
Mean (Standard Deviation) [Ratio of MS in the total bacterial count]
6.1
(15.7)
11.6
(17.8)
5. Secondary Outcome
TitleMothers' Gingival Bleeding
DescriptionPercentage of probing sites with gingival bleeding (BOP%, range 0-100%)
Time Frame12 months

Outcome Measure Data

Analysis Population Description
The numbers of participants analyzed here are those who finished basiline and one-year follow-up gingival bleeding examination.
Arm/Group TitlePersonal Oral Health Instruction + Pamphlets DistributionPamphlets Distribution
Arm/Group DescriptionPersonal 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 distributionPamphlets 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
Measure Participants188181
Mean (Standard Deviation) [Percentage of sites with bleeding]
35
(29)
46
(26)

Adverse Events

Time Frame1 year, 2 years and 3 years followup
Adverse Event Reporting Description
Arm/Group TitlePersonal Oral Health Instruction + Pamphlets DistributionPamphlets Distribution
Arm/Group DescriptionPersonal 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 distributionPamphlets 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
All Cause Mortality
Personal Oral Health Instruction + Pamphlets DistributionPamphlets Distribution
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/294 (0%) 0/286 (0%)
Serious Adverse Events
Personal Oral Health Instruction + Pamphlets DistributionPamphlets Distribution
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/294 (0%) 0/286 (0%)
Other (Not Including Serious) Adverse Events
Personal Oral Health Instruction + Pamphlets DistributionPamphlets Distribution
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/294 (0%) 0/286 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleProf Wong, May Chun Mei
OrganizationThe University of Hong Kong
Phone852-28590422
Emailmcmwong@hku.hk
Responsible Party:
Professor May C.M. Wong, Professor, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT02937194
Other Study ID Numbers:
  • GRF HKU 782213M
First Posted:
Oct 18, 2016
Last Update Posted:
Apr 22, 2021
Last Verified:
Mar 1, 2021